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

Sierra Oncology

Status and phase: Terminated; Phase 1

Conditions: Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02244489

GS-US-370-1369

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Momelotinib (MMB)+capecitabine

Experimental group

Description:

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

Treatment:

Drug: Momelotinib (MMB)

Drug: Capecitabine

Momelotinib (MMB)+capecitabine+oxaliplatin

Experimental group

Description:

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.

Treatment:

Drug: Oxaliplatin

Drug: Momelotinib (MMB)

Drug: Capecitabine