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Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Primary Purpose

Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Momelotinib (MMB)

Capecitabine

Oxaliplatin

About this trial

This is an interventional treatment trial for Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

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

Key Inclusion Criteria:

Relapsed or refractory metastatic pancreatic adenocarcinoma
Received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy)
Measurable disease per RECIST v1.1
Adequate organ function defined as
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) OR ≤ 5 x ULN if liver metastases are present; total conjugated bilirubin ≤ 2 x ULN
- Absolute neutrophil count (ANC) ≥1500 cells/mm^3, platelet ≥100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dL
- Creatinine clearance (CrCl) > 50 ml/min as calculated by the Cockroft-Gault method
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Key Exclusion Criteria:

Received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma
Major surgery within 21 days of first dose of study drug
Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable)
Chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug
Known positive status for HIV, chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
Known dihydropyrimidine dehydrogenase deficiency
Peripheral neuropathy ≥ Grade 2
Any condition that impairs gastrointestinal absorption of drug
Known or suspected brain or central nervous system metastases
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
External biliary drain
Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Scottsdale Healthcare Research Institute
Cedars-Sinai Medical Center
Tennessee Oncology
Virginia Cancer Specialists, PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Momelotinib (MMB)+capecitabine

Momelotinib (MMB)+capecitabine+oxaliplatin

Arm Description

Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine.

Upon reaching the MTD for momelotinib (MMB) and capecitabine or if no MTD is reached, participants will receive momelotinib (MMB)+capecitabine at the MTD plus oxaliplatin at varying dose levels to determine the MTD of combination capecitabine, momelotinib (MMB), and oxaliplatin.

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities

Dose limiting toxicities refer to toxicities experienced during the first 21 days of treatment that have been judged to be clinically significant and at least possibly related to study treatment.

Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements

This composite endpoint will measure the safety profile of momelotinib.

Secondary Outcome Measures

Overall response rate

Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Overall survival

Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause.

Progression-free survival

Progression-free survival (PFS) is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST criteria v1.1.

Pharmacokinetic (PK) profile of momelotinib (MMB)

This composite endpoint will measure the plasma PK profile of momelotinib (MMB). The following parameters will be measured, where applicable: Cmax: maximum observed concentration of drug in plasma Ctau: observed drug concentration at the end of the dosing interval AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)

Full Information

NCT ID

NCT02244489

First Posted

September 17, 2014

Last Updated

January 30, 2019

Sponsor

Sierra Oncology LLC - a GSK company

1. Study Identification

Unique Protocol Identification Number

NCT02244489

Brief Title

Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Official Title

A Phase 1b Study Evaluating Momelotinib Combined With Capecitabine and Oxaliplatin in Subjects With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Study Start Date

November 5, 2014 (Actual)

Primary Completion Date

March 8, 2017 (Actual)

Study Completion Date

April 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sierra Oncology LLC - a GSK company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Momelotinib (MMB)+capecitabine

Arm Type

Experimental

Arm Description

Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine.

Arm Title

Momelotinib (MMB)+capecitabine+oxaliplatin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Momelotinib (MMB)

Other Intervention Name(s)

GS-0387, CYT387

Intervention Description

Momelotinib (MMB) tablet(s) administered orally once or twice daily

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.

Primary Outcome Measure Information:

Title

Incidence of dose limiting toxicities

Description

Dose limiting toxicities refer to toxicities experienced during the first 21 days of treatment that have been judged to be clinically significant and at least possibly related to study treatment.

Time Frame

Up to 21 days

Title

Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements

Description

This composite endpoint will measure the safety profile of momelotinib.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Overall response rate

Description

Time Frame

Up to 2 years

Title

Overall survival

Description

Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause.

Time Frame

Up to 2 years

Title

Progression-free survival

Description

Time Frame

Up to 2 years

Title

Pharmacokinetic (PK) profile of momelotinib (MMB)

Description

Time Frame

Predose and postdose on Day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Relapsed or refractory metastatic pancreatic adenocarcinoma Received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy) Measurable disease per RECIST v1.1 Adequate organ function defined as Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) OR ≤ 5 x ULN if liver metastases are present; total conjugated bilirubin ≤ 2 x ULN Absolute neutrophil count (ANC) ≥1500 cells/mm^3, platelet ≥100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dL Creatinine clearance (CrCl) > 50 ml/min as calculated by the Cockroft-Gault method Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Key Exclusion Criteria: Received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma Major surgery within 21 days of first dose of study drug Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable) Chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug Known positive status for HIV, chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier Known dihydropyrimidine dehydrogenase deficiency Peripheral neuropathy ≥ Grade 2 Any condition that impairs gastrointestinal absorption of drug Known or suspected brain or central nervous system metastases Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma External biliary drain Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Scottsdale Healthcare Research Institute

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Tennessee Oncology

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Virginia Cancer Specialists, PC

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

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