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A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

Primary Purpose

Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
INCB001158
Oxaliplatin
Leucovorin
5-Fluorouracil
Gemcitabine
Cisplatin
Paclitaxel
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer (BTC) focused on measuring INCB001158, arginase inhibitor, oxaliplatin, leucovorin, 5 fluorouracil, gemcitabine, cisplatin, paclitaxel, solid tumors, colorectal cancer, biliary tract cancer, gastroesophageal cancer, endometrial cancer, ovarian cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
  • Presence of measurable disease per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
  • Resolution of treatment-related toxicities.
  • Adequate hepatic, renal, cardiac, and hematologic function.
  • Additional cohort-specific criteria may apply.

Exclusion Criteria:

  • Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
  • Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
  • Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
  • Has received prior approved radiotherapy within 14 days of study therapy.
  • Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has an active infection requiring systemic therapy.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Women who are pregnant or breastfeeding.

Sites / Locations

  • University of Alabama
  • USA Mitchell Cancer Center
  • UC Davis - Comprehensive Cancer Centre
  • Northwest Georgia Oncology Centers
  • The University of Texas MD Anderson Cancer Center
  • START San Antonio
  • Grand Hopital de Charleroi - Department of Medical Oncology
  • Institut Jules Bordet - Clinical Trials Conduct Unit
  • UCL Cancer Institute
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Treatment Group A

Treatment Group B

Treatment Group C

Arm Description

INCB001158 + FOLFOX

INCB001158 + gemcitabine/cisplatin

INCB001158 + paclitaxel

Outcomes

Primary Outcome Measures

Phase 1: Participants with treatment-emergent adverse events (TEAE)
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Phase 2: Objective response rate
Defined as the percentage of subjects having a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Outcome Measures

Phase 2: Participants with TEAEs
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Phase 1: Objective response rate
Defined as the percentage of subjects having a CR or PR per RECIST v1.1.
Duration of response
Defined as the time from earliest date of CR or PR (per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if occurring sooner than disease progression.
Disease control rate
Defined as the percentage of subjects having CR, PR, or stable disease for at least 8 weeks (per RECIST v1.1).
Progression-free survival
Defined as the time from date of first dose of study drug until the earliest date of disease progression (per RECIST v1.1) or death due to any cause, if occurring sooner than progression.

Full Information

First Posted
October 16, 2017
Last Updated
December 22, 2022
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03314935
Brief Title
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Official Title
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
November 28, 2022 (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
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC), Ovarian Cancer, Solid Tumors
Keywords
INCB001158, arginase inhibitor, oxaliplatin, leucovorin, 5 fluorouracil, gemcitabine, cisplatin, paclitaxel, solid tumors, colorectal cancer, biliary tract cancer, gastroesophageal cancer, endometrial cancer, ovarian cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A
Arm Type
Experimental
Arm Description
INCB001158 + FOLFOX
Arm Title
Treatment Group B
Arm Type
Experimental
Arm Description
INCB001158 + gemcitabine/cisplatin
Arm Title
Treatment Group C
Arm Type
Experimental
Arm Description
INCB001158 + paclitaxel
Intervention Type
Drug
Intervention Name(s)
INCB001158
Other Intervention Name(s)
Arginase inhibitor
Intervention Description
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Leucovorin at the protocol-defined dose and regimen.
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
5-Fluorouracil at the protocol-defined dose and regimen.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine at the protocol-defined dose and regimen.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin at the protocol-defined dose and regimen.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel at the protocol-defined dose and regimen.
Primary Outcome Measure Information:
Title
Phase 1: Participants with treatment-emergent adverse events (TEAE)
Description
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
28 days
Title
Phase 2: Objective response rate
Description
Defined as the percentage of subjects having a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time Frame
Every 8 weeks for duration of study participation which is estimated to be 18 months.
Secondary Outcome Measure Information:
Title
Phase 2: Participants with TEAEs
Description
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Screening through 90 days after end of treatment, up to 21 months.
Title
Phase 1: Objective response rate
Description
Defined as the percentage of subjects having a CR or PR per RECIST v1.1.
Time Frame
Every 8 weeks for duration of study participation, up to 18 months.
Title
Duration of response
Description
Defined as the time from earliest date of CR or PR (per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if occurring sooner than disease progression.
Time Frame
Every 8 weeks for duration of study participation, up to 18 months.
Title
Disease control rate
Description
Defined as the percentage of subjects having CR, PR, or stable disease for at least 8 weeks (per RECIST v1.1).
Time Frame
Every 8 weeks for duration of study participation, up to 18 months.
Title
Progression-free survival
Description
Defined as the time from date of first dose of study drug until the earliest date of disease progression (per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
Time Frame
Every 8 weeks for duration of study participation, up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors. Presence of measurable disease per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Resolution of treatment-related toxicities. Adequate hepatic, renal, cardiac, and hematologic function. Additional cohort-specific criteria may apply. Exclusion Criteria: Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose. Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug. Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment. Has received prior approved radiotherapy within 14 days of study therapy. Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry. Has an active autoimmune disease that has required systemic treatment in past 2 years. Has an active infection requiring systemic therapy. Has known active CNS metastases and/or carcinomatous meningitis. Women who are pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Leopold, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
USA Mitchell Cancer Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
UC Davis - Comprehensive Cancer Centre
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Northwest Georgia Oncology Centers
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
START San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grand Hopital de Charleroi - Department of Medical Oncology
City
Brussels
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Institut Jules Bordet - Clinical Trials Conduct Unit
City
Brussels
ZIP/Postal Code
B-1000
Country
Belgium
Facility Name
UCL Cancer Institute
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

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