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

NCT02244489

TerminatedPhase 1

Sponsor: Sierra Oncology LLC - a GSK company

Conditions: Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: Momelotinib (MMB), Capecitabine, Oxaliplatin

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (4)

Scottsdale, Arizona, United States
Los Angeles, California, United States
Nashville, Tennessee, United States
Fairfax, Virginia, United States