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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02101021
First received: March 28, 2014
Last updated: July 28, 2014
Last verified: July 2014

March 28, 2014
July 28, 2014
June 2014
August 2016   (final data collection date for primary outcome measure)
  • For the lead-in phase, the incidence of DLTs [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
    Dose limiting toxicities (DLTs) refer to toxicities experienced during the first 28 days of treatment that have been judged to be clinically significant and related to study treatment.
  • For the randomized treatment phase, overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the interval from randomization to death from any cause.
  • For the randomized treatment phase, overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the interval from randomization to death from any cause.
  • For the lead-in phase, the incidence of DLTs [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]

    Dose limiting toxicities (DLTs) refer to toxicities experienced during the first 28 days of treatment that have been judged to be clinically significant and related to study treatment. DLTs were defined as any of the following:

    • Grade 4 neutropenia lasting > 5 days
    • Grade ≥ 3 neutropenia with fever (temperature ≥ 100.5º F)
    • Grade 4 thrombocytopenia
    • Grade 3 or higher non-hematologic toxicity, excluding:

      • Grade 3 nausea or emesis with maximum duration of 48 hours on adequate medical therapy
      • Grade 3 diarrhea with maximum duration of 48 hours on adequate medical therapy
      • Alopecia
    • A treatment-emergent adverse event (AE) that in the opinion of the investigator is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk
    • Any treatment delay > 4 weeks that is due to study treatment-related adverse effects
Complete list of historical versions of study NCT02101021 on ClinicalTrials.gov Archive Site
  • For the lead-in phase, overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the interval from the first dose date of drug to death from any cause.
  • For the lead-in phase, progression free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Progression free survival is defined as the interval from the first dose date of drug during the lead-in phase to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1.
  • For the lead-in phase, overall response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Overall response rate is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as assessed by RECIST v1.1.
  • For the randomized treatment phase, progression free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Progression free survival is defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST v1.1 criteria.
  • For the randomized treatment phase, overall response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Overall response rate is defined as the proportion of subjects who achieve a CR or PR as assessed by RECIST v1.1.
Same as current
Not Provided
Not Provided
 
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 2, Randomized, Double-blind 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

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 combined with nab-paclitaxel and gemcitabine in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and tolerability of nab-paclitaxel and gemcitabine combined with either momelotinib administered at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma as measured by improvement in overall survival (OS), progression free survival (PFS), and overall response rate (ORR). 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 6 months for up to 5 years.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Metastatic Pancreatic Ductal Adenocarcinoma
  • Drug: Momelotinib
    Momelotinib tablets administered orally once or twice daily
    Other Names:
    • GS-0387
    • CYT387
  • Drug: Placebo to match momelotinib
    Placebo to match momelotinib tablets administered orally once or twice daily
  • Drug: Nab-paclitaxel
    Nab-paclitaxel administered intravenously over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
  • Drug: Gemcitabine
    Gemcitabine administered intravenously over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
  • Experimental: Momelotinib
    Participants will receive momelotinib plus nab-paclitaxel and gemcitabine.
    Interventions:
    • Drug: Momelotinib
    • Drug: Nab-paclitaxel
    • Drug: Gemcitabine
  • Placebo Comparator: Placebo
    Participants will receive placebo to match momelotinib plus nab-paclitaxel and gemcitabine.
    Interventions:
    • Drug: Placebo to match momelotinib
    • Drug: Nab-paclitaxel
    • Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
336
August 2021
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Initial diagnosis of metastatic pancreatic adenocarcinoma must have occurred ≤ 6 wks prior to enrollment
  • 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 < 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

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
  • Paracentesis or thoracentesis for malignant effusion within 14 days of enrollment
  • Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment
Both
18 Years and older
No
Contact: Clinical Study Team momelotinib.studies@gilead.com
United States
 
NCT02101021
GS-US-370-1296
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Peter Lee, MD, PhD Gilead Sciences
Gilead Sciences
July 2014

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