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Trial record 8 of 13 for:    momelotinib

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

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ClinicalTrials.gov Identifier: NCT02244489
Recruitment Status : Terminated
First Posted : September 19, 2014
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma Drug: MMB Drug: Capecitabine Drug: Oxaliplatin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study Evaluating Momelotinib Combined With Capecitabine and Oxaliplatin in Subjects With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : November 5, 2014
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MMB+capecitabine
Participants will receive MMB+capecitabine at varying dose levels to determine the MTD for MMB and capecitabine.
Drug: 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

Experimental: MMB+capecitabine+oxaliplatin
Upon reaching the MTD for MMB and capecitabine or if no MTD is reached, participants will receive MMB+capecitabine at the MTD plus oxaliplatin at varying dose levels to determine the MTD of combination capecitabine, MMB, and oxaliplatin.
Drug: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244489


Locations
United States, Arizona
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02244489     History of Changes
Other Study ID Numbers: GS-US-370-1369
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents