Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metasta… (NCT02244489) | Clinical Trial Compass
TerminatedPhase 1
Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
United States16 participantsStarted 2014-11-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≥ Gr…
What they're measuring
1
Incidence of dose limiting toxicities
Timeframe: Up to 21 days
2
Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements