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Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT02101021
Recruitment Status : Terminated
First Posted : April 1, 2014
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
There will be two phases to this study. The lead-in phase will evaluate the safety, pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with nab-paclitaxel and gemcitabine (nab-P + G) in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and tolerability of nab-P + G with either MMB administered at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. Participants will continue study treatment until disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment. Following treatment, participants will be followed for safety for 30 days and for survival approximately every 3 months for up to 3 years.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Ductal Adenocarcinoma Drug: Momelotinib Drug: Placebo to match momelotinib Drug: Nab-paclitaxel Drug: Gemcitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase
Actual Study Start Date : June 2, 2014
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Momelotinib
Participants will receive momelotinib plus nab-paclitaxel and gemcitabine.
Drug: Momelotinib
Tablet (s) administered orally once or twice daily
Other Names:
  • GS-0387
  • CYT387
Drug: Nab-paclitaxel
Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
Drug: Gemcitabine
Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
Placebo Comparator: Placebo
Participants will receive placebo to match momelotinib plus nab-paclitaxel and gemcitabine.
Drug: Placebo to match momelotinib
Placebo to match momelotinib tablets administered orally once or twice daily
Drug: Nab-paclitaxel
Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
Drug: Gemcitabine
Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle



Primary Outcome Measures :
  1. Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events [ Time Frame: Up to 28 Days ]

    Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment.

    No statistical analysis was planned or performed for this endpoint.


  2. Randomized Treatment Phase: Overall Survival (OS) [ Time Frame: Baseline up to the Date of Death or Censoring ]
    Overall survival was defined as the time interval from first dose date of MMB to death from any cause


Secondary Outcome Measures :
  1. Lead-In Phase: Overall Survival (OS) [ Time Frame: Baseline up to the Date of Death or Censoring ]
    Overall survival was defined as the time interval from first dose date of MMB to death from any cause

  2. Lead-In Phase: Progression-Free Survival (PFS) [ Time Frame: Baseline up to the Date of Event or Censoring ]
    Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause

  3. Lead-In Phase: Overall Response Rate (ORR) [ Time Frame: Baseline up to the Last Tumor Assessment Date ]
    The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR)

  4. Randomized Treatment Phase: Progression-Free Survival (PFS) [ Time Frame: Baseline up to the Date of Event or Censoring ]
    Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause

  5. Randomized Treatment Phase: Overall Response Rate [ Time Frame: Baseline up to the Last Tumor Assessment Date ]
    The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR)



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

Key Inclusion Criteria:

  • Presence of metastatic pancreatic adenocarcinoma plus 1 of the following:

    • Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
    • Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin in conjunction with either:

      • The presence of a mass in the pancreas, OR
      • A history of resected pancreatic adenocarcinoma
  • Measurable disease per RECIST v1.1
  • Adequate organ function defined as follows:

    • Total bilirubin ≤ 1.25 x upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
    • Absolute neutrophil count (ANC) > 1500 cells/mm^3, platelet > 100,000 cells/mm^3, hemoglobin > 9 g/dL
    • Serum creatinine < ULN OR calculated creatinine clearance (CrCl) of ≥ 60 ml/min
  • Eastern Cooperative Oncology Group (ECOG ) 0 or 1
  • Modified Glasgow prognostic score (mGPS) of 1 or 2 at Screening (randomized phase only)

Key Exclusion Criteria:

  • Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
  • Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic pancreatic carcinoma
  • Major surgery within 28 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)
  • Known positive status for HIV
  • Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
  • Peripheral neuropathy ≥ Grade 2
  • 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
  • History of interstitial pneumonitis and/or require supplemental oxygen therapy
  • 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): NCT02101021


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Indiana
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46506
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Washington
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] February 11, 2014
Statistical Analysis Plan  [PDF] July 10, 2017
Study Protocol: Amendment 1  [PDF] March 14, 2014
Study Protocol: Amendment 2  [PDF] August 25, 2014
Study Protocol: Amendment 3  [PDF] July 16, 2015


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02101021     History of Changes
Other Study ID Numbers: GS-US-370-1296
2014-004480-20 ( EudraCT Number )
First Posted: April 1, 2014    Key Record Dates
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018
Last Verified: April 2018

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
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs