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Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

Primary Purpose

Lung Cancer, Solid Tumor, Gastric Cancer

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pemigatinib
Gemcitabine
Pembrolizumab
Docetaxel
Trastuzumab
Retifanlimab
Cisplatin
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring alterations in FGF or FGFR, squamous non-small cell lung cancer, gastric cancer, urothelial cancer, endometrial cancer, multiple myeloma, MPN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female subjects, age 18 years or older on day of signing consent
  2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
  3. Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
  4. Life expectancy > 12 weeks

  5. Eastern Cooperative Oncology Group (ECOG) performance status:

    • Part 1: 0 or 1
    • Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

  1. Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
  2. Prior receipt of a selective FGFR inhibitor
  3. History of a calcium/phosphate homeostasis disorder
  4. History and/or current evidence of ectopic mineralization/calcification
  5. Current evidence of corneal disorder/keratopathy
  6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
  7. Prior radiotherapy within 2 weeks of study treatment

Sites / Locations

  • University of Alabama At Birmingham Comprehensive Cancer Center
  • Cedars-Sinai Medical Center
  • Yale Cancer Center
  • Georgetown University Hospital
  • Hematology Oncology Associates of the Tr
  • Emory University - Winship Cancer Institute
  • University of Michigan Health System
  • Washington University School of Medicine
  • John Theurer Cancer Center, Hackensack University Medical Center
  • Montefiore Medical Center
  • Northwell Health - Monter Cancer Center
  • Duke University Medical Center
  • Ohio State University - Wexner Medical Center
  • Signal Point Clinical Research Center
  • Greenville Health System Cancer Institute
  • Mary Crowley Cancer Research Ctr
  • Md Anderson Cancer Center
  • South Texas Accelerated Research Therapeutics
  • Baylor Scott & White Health
  • The Finsen Centre National Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1: Intermittent pemigatinib 1/2/4 mg QD

Part 1: Intermittent pemigatinib 6 mg QD

Part 1: Intermittent pemigatinib 9 mg QD

Part 1: Intermittent pemigatinib 13.5 mg QD

Part 1: Intermittent pemigatinib 20 mg QD

Part 1: Continuous pemigatinib 9 mg QD

Part 1: Continuous pemigatinib 13.5 mg QD

Part 1: Continuous pemigatinib 20 mg QD

Part 1: Continuous pemigatinib 7.5 mg BID

Part 1: Continuous pemigatinib 10 mg BID

Part 2: Intermittent pemigatinib 9 mg QD

Part 2: Intermittent pemigatinib 13.5 mg QD

Part 2: Continuous pemigatinib 9 mg QD

Part 2: Continuous pemigatinib 13.5 mg QD

Part 2: Continuous pemigatinib 20 mg QD

Part 3: Gem/Cis/intermittent pemigatinib 9 mg

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg

Part 3: Tras/intermittent pemigatinib 13.5 mg

Part 3: Doc/intermittent pemigatinib 13.5 mg

Part 3: Pem/intermittent pemigatinib 9 mg

Part 3: Pem/intermittent pemigatinib 13.5 mg

Part 3: Pem/continuous pemigatinib 13.5 mg

Part 3: Ref/continuous pemigatinib 9 mg

Part 3: Ref/continuous pemigatinib 13.5 mg

Part 3: Ref/continuous pemigatinib 20 mg

Arm Description

Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.

Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.

Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m^2) (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.

Participants received gemcitabine intravenously starting at 1000 mg/m^2 (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.

Trastuzumab (Tras) was administered as an open-label, commercial product at an initial dose of 8 mg/kilograms (kg) over a 90-minute intravenous infusion, followed by 6 mg/kg over a 30- to 90-minute intravenous infusion once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.

Participants received docetaxel (Doc) intravenously starting at 75 mg/m^2 (1 hour) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.

Participants received pembrolizumab (Pem) intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Outcomes

Primary Outcome Measures

Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
Part 3: Number of Participants With Any TEAE
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
E0 was defined as the Baseline serum concentration of phosphate.
EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.
Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2
Serum phosphate concentration was assessed throughout Parts 1 and 2.

Secondary Outcome Measures

Part 2: Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Part 3: ORR
ORR was defined as the percentage of participants with a best overall response of CR or PR, per RECIST version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Cmax was defined as the maximum observed plasma concentration.
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
tmax was defined as the time to the maximum observed plasma concentration.
Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Cmax was defined as the maximum observed plasma concentration.
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
tmax was defined as the time to the maximum observed plasma concentration.
Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
CL/F was defined as the apparent oral dose clearance.
Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Vz/F was defined as the apparent volume of distribution.
Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.
Parts 1 and 2: Cmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Cmax was defined as the maximum observed plasma concentration.
Parts 1 and 2: Tmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
tmax was defined as the time to the maximum observed plasma concentration.
Parts 1 and 2: t1/2 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Parts 1 and 2: AUC0-24 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Parts 1 and 2: CL/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
CL/F was defined as the apparent oral dose clearance.
Parts 1 and 2: Vz/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Vz/F was defined as the apparent volume of distribution.
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Cmax was defined as the maximum observed plasma concentration.
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
tmax was defined as the time to the maximum observed plasma concentration.
Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Cmax was defined as the maximum observed plasma concentration.
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
tmax was defined as the time to the maximum observed plasma concentration.
Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
CL/F was defined as the apparent oral dose clearance.
Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Vz/F was defined as the apparent volume of distribution.
Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.

Full Information

First Posted
January 30, 2015
Last Updated
December 12, 2022
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02393248
Brief Title
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
Official Title
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Study Start Date
February 27, 2015 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Solid Tumor, Gastric Cancer, Urothelial Cancer, Endometrial Cancer, Multiple Myeloma, Myeloproliferative Neoplasms, Breast Cancer, Cholangiocarcinoma, UC, MPN
Keywords
alterations in FGF or FGFR, squamous non-small cell lung cancer, gastric cancer, urothelial cancer, endometrial cancer, multiple myeloma, MPN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Intermittent pemigatinib 1/2/4 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Arm Title
Part 1: Intermittent pemigatinib 6 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Arm Title
Part 1: Intermittent pemigatinib 9 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Arm Title
Part 1: Intermittent pemigatinib 13.5 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Arm Title
Part 1: Intermittent pemigatinib 20 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Arm Title
Part 1: Continuous pemigatinib 9 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 1: Continuous pemigatinib 13.5 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 1: Continuous pemigatinib 20 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 1: Continuous pemigatinib 7.5 mg BID
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 1: Continuous pemigatinib 10 mg BID
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 2: Intermittent pemigatinib 9 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Arm Title
Part 2: Intermittent pemigatinib 13.5 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Arm Title
Part 2: Continuous pemigatinib 9 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 2: Continuous pemigatinib 13.5 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 2: Continuous pemigatinib 20 mg QD
Arm Type
Experimental
Arm Description
Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 3: Gem/Cis/intermittent pemigatinib 9 mg
Arm Type
Experimental
Arm Description
Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m^2) (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
Arm Title
Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg
Arm Type
Experimental
Arm Description
Participants received gemcitabine intravenously starting at 1000 mg/m^2 (30 minutes) on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m^2 (1-4 hours) once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
Arm Title
Part 3: Tras/intermittent pemigatinib 13.5 mg
Arm Type
Experimental
Arm Description
Trastuzumab (Tras) was administered as an open-label, commercial product at an initial dose of 8 mg/kilograms (kg) over a 90-minute intravenous infusion, followed by 6 mg/kg over a 30- to 90-minute intravenous infusion once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.
Arm Title
Part 3: Doc/intermittent pemigatinib 13.5 mg
Arm Type
Experimental
Arm Description
Participants received docetaxel (Doc) intravenously starting at 75 mg/m^2 (1 hour) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.
Arm Title
Part 3: Pem/intermittent pemigatinib 9 mg
Arm Type
Experimental
Arm Description
Participants received pembrolizumab (Pem) intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
Arm Title
Part 3: Pem/intermittent pemigatinib 13.5 mg
Arm Type
Experimental
Arm Description
Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
Arm Title
Part 3: Pem/continuous pemigatinib 13.5 mg
Arm Type
Experimental
Arm Description
Participants received pembrolizumab intravenously at 200 mg (30 minutes) once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
Arm Title
Part 3: Ref/continuous pemigatinib 9 mg
Arm Type
Experimental
Arm Description
Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 3: Ref/continuous pemigatinib 13.5 mg
Arm Type
Experimental
Arm Description
Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
Arm Title
Part 3: Ref/continuous pemigatinib 20 mg
Arm Type
Experimental
Arm Description
Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial dose of 500 mg over a 60-minute intravenous infusion. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Other Intervention Name(s)
INCB054828
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Type
Drug
Intervention Name(s)
Retifanlimab
Other Intervention Name(s)
INCMGA00012
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Primary Outcome Measure Information:
Title
Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Description
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
Time Frame
up to 763 days
Title
Part 3: Number of Participants With Any TEAE
Description
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
Time Frame
up to 869 days
Title
E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Description
E0 was defined as the Baseline serum concentration of phosphate.
Time Frame
predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Title
EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Description
EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
Time Frame
predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Title
Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Description
Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.
Time Frame
predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Title
Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2
Description
Serum phosphate concentration was assessed throughout Parts 1 and 2.
Time Frame
predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
Secondary Outcome Measure Information:
Title
Part 2: Overall Response Rate (ORR)
Description
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Time Frame
up to 126 days
Title
Part 3: ORR
Description
ORR was defined as the percentage of participants with a best overall response of CR or PR, per RECIST version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Time Frame
up to 203 days
Title
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Description
Cmax was defined as the maximum observed plasma concentration.
Time Frame
Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Title
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Description
tmax was defined as the time to the maximum observed plasma concentration.
Time Frame
Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Title
Parts 1 and 2: AUClast After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Description
AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.
Time Frame
Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Title
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
Description
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Time Frame
Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
Title
Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
Cmax was defined as the maximum observed plasma concentration.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
tmax was defined as the time to the maximum observed plasma concentration.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: t1/2 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: Cmin After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: CL/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
CL/F was defined as the apparent oral dose clearance.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: Vz/F After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
Vz/F was defined as the apparent volume of distribution.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: Accumulation Ratio After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
Description
The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.
Time Frame
Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Parts 1 and 2: Cmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Description
Cmax was defined as the maximum observed plasma concentration.
Time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Title
Parts 1 and 2: Tmax Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Description
tmax was defined as the time to the maximum observed plasma concentration.
Time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Title
Parts 1 and 2: t1/2 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Description
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Title
Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Description
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Title
Parts 1 and 2: AUC0-24 Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Description
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Title
Parts 1 and 2: CL/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Description
CL/F was defined as the apparent oral dose clearance.
Time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Title
Parts 1 and 2: Vz/F Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
Description
Vz/F was defined as the apparent volume of distribution.
Time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
Title
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Description
Cmax was defined as the maximum observed plasma concentration.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Title
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Description
tmax was defined as the time to the maximum observed plasma concentration.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Title
Part 3: AUClast of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Description
AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Title
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 1
Description
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Title
Part 3: Cmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
Cmax was defined as the maximum observed plasma concentration.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
tmax was defined as the time to the maximum observed plasma concentration.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Part 3: t1/2 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
t1/2 was defined as the apparent plasma terminal phase disposition half-life.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Part 3: Cmin of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Part 3: AUC0-24 of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Part 3: CL/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
CL/F was defined as the apparent oral dose clearance.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Part 3: Vz/F of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
Vz/F was defined as the apparent volume of distribution.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
Title
Part 3: Accumulation Ratio of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Description
The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.
Time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects, age 18 years or older on day of signing consent Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant) Life expectancy > 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0 or 1 Part 2 and 3: 0, 1, or 2 Exclusion Criteria: Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug Prior receipt of a selective FGFR inhibitor History of a calcium/phosphate homeostasis disorder History and/or current evidence of ectopic mineralization/calcification Current evidence of corneal disorder/keratopathy Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range Prior radiotherapy within 2 weeks of study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Féliz, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama At Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Hematology Oncology Associates of the Tr
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
John Theurer Cancer Center, Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Northwell Health - Monter Cancer Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University - Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Greenville Health System Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Mary Crowley Cancer Research Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
The Finsen Centre National Hospital
City
Copenhagen
ZIP/Postal Code
02100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35176457
Citation
Subbiah V, Iannotti NO, Gutierrez M, Smith DC, Feliz L, Lihou CF, Tian C, Silverman IM, Ji T, Saleh M. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Ann Oncol. 2022 May;33(5):522-533. doi: 10.1016/j.annonc.2022.02.001. Epub 2022 Feb 14.
Results Reference
derived
PubMed Identifier
34951522
Citation
Gong X, Ji T, Liu X, Chen X, Yeleswaram S. Evaluation of the clinical cardiac safety of pemigatinib, a fibroblast growth factor receptor inhibitor, in participants with advanced malignancies. Pharmacol Res Perspect. 2022 Feb;10(1):e00906. doi: 10.1002/prp2.906.
Results Reference
derived

Learn more about this trial

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

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