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

NCT02244489 | Terminated Phase 1 FDA Drug

• 1 other identifier: GS-US-370-1369
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Overall response rate

  Up to 2 years

• Overall survival

  Up to 2 years

• Progression-free survival

  Up to 2 years

• Pharmacokinetic (PK) profile of momelotinib (MMB)

  Predose and postdose on Day 15

Study Arms (2)

Momelotinib (MMB)+capecitabine

EXPERIMENTAL

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

Drug: Momelotinib (MMB); Drug: Capecitabine

Momelotinib (MMB)+capecitabine+oxaliplatin

EXPERIMENTAL

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.

Drug: Momelotinib (MMB); Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Momelotinib (MMB) DRUG

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

Also known as: GS-0387, CYT387

Momelotinib (MMB)+capecitabine; Momelotinib (MMB)+capecitabine+oxaliplatin

Capecitabine DRUG

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

Momelotinib (MMB)+capecitabine; Momelotinib (MMB)+capecitabine+oxaliplatin

Oxaliplatin DRUG

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

Momelotinib (MMB)+capecitabine+oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sierra Oncology LLC - a GSK company: lead

Study Sites (4)

Scottsdale Healthcare Research Institute

Scottsdale, Arizona, 85258, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Recurrence

Interventions

N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 19, 2014
• Study Start: November 5, 2014
• Primary Completion: March 8, 2017
• Study Completion: April 5, 2017
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

US (4)