Momelotinib Combined With Capecitabine And Oxaliplatin In Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Study Overview

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

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.

N/A

Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

DRUG: Momelotinib (MMB)
DRUG: Capecitabine
DRUG: Oxaliplatin

GS-US-370-1369

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-09-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-30
First Submitted that Met QC Criteria 2014-09-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-02-01
First Posted (ACTUAL) 2014-09-19	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Momelotinib (MMB)+capecitabine Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine.	DRUG: Momelotinib (MMB) Momelotinib (MMB) tablet(s) administered orally once or twice daily DRUG: Capecitabine Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment DRUG: Oxaliplatin Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.
EXPERIMENTAL: Momelotinib (MMB)+capecitabine+oxaliplatin 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	DRUG: Momelotinib (MMB) Momelotinib (MMB) tablet(s) administered orally once or twice daily DRUG: Capecitabine Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment DRUG: Oxaliplatin Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Momelotinib (MMB)+capecitabine

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

DRUG: Momelotinib (MMB)

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

DRUG: Capecitabine

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

DRUG: Oxaliplatin

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

EXPERIMENTAL: Momelotinib (MMB)+capecitabine+oxaliplatin

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

DRUG: Momelotinib (MMB)

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

DRUG: Capecitabine

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

DRUG: Oxaliplatin

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

Primary Outcome Measures	Measure Description	Time Frame
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.	Up to 21 days
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.	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
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.	Up to 2 years
Overall survival	Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause.	Up to 2 years
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.	Up to 2 years
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)	Predose and postdose on Day 15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Gilead Study Director, Gilead Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record