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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02244489
Recruitment Status : Terminated
First Posted : September 19, 2014
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sierra Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE September 17, 2014
First Posted Date  ICMJE September 19, 2014
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE November 5, 2014
Actual Primary Completion Date March 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Incidence of dose limiting toxicities [ Time Frame: Up to 21 days ]
    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.
  • Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements [ Time Frame: Up to 2 years ]
    This composite endpoint will measure the safety profile of momelotinib.
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2014)
  • Incidence of dose limiting toxicities [ Time Frame: Up to 21 days ]
    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.
  • Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements [ Time Frame: Up to 3 years ]
    This composite endpoint will measure the safety profile of momelotinib.
  • Pharmacokinetic (PK) profile of MMB [ Time Frame: Predose and postdose on Day 15 ]
    This composite endpoint will measure the plasma PK profile of 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)
Change History Complete list of historical versions of study NCT02244489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Overall response rate [ Time Frame: Up to 2 years ]
    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.
  • Overall survival [ Time Frame: Up to 2 years ]
    Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause.
  • Progression-free survival [ Time Frame: Up to 2 years ]
    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.
  • Pharmacokinetic (PK) profile of momelotinib (MMB) [ Time Frame: Predose and postdose on Day 15 ]
    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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2014)
  • Overall response rate [ Time Frame: Up to 3 years ]
    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.
  • Overall survival [ Time Frame: Up to 3 years ]
    Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause.
  • Progression-free survival [ Time Frame: Up to 3 years ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
Official Title  ICMJE A Phase 1b Study Evaluating Momelotinib Combined With Capecitabine and Oxaliplatin in Subjects With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
Intervention  ICMJE
  • Drug: Momelotinib (MMB)
    Momelotinib (MMB) tablet(s) administered orally once or twice daily
    Other Names:
    • GS-0387
    • CYT387
  • 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.
Study Arms  ICMJE
  • Experimental: Momelotinib (MMB)+capecitabine
    Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine.
    Interventions:
    • Drug: Momelotinib (MMB)
    • Drug: Capecitabine
  • 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 (MMB), and oxaliplatin.
    Interventions:
    • Drug: Momelotinib (MMB)
    • Drug: Capecitabine
    • Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 21, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2014)
30
Actual Study Completion Date  ICMJE April 5, 2017
Actual Primary Completion Date March 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02244489
Other Study ID Numbers  ICMJE GS-US-370-1369
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sierra Oncology, Inc.
Study Sponsor  ICMJE Sierra Oncology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Sierra Oncology, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP