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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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Metastatic Pancreatic Ductal Adenocarcinoma
Interventions: Drug: Momelotinib
Drug: Placebo to match momelotinib
Drug: Nab-paclitaxel
Drug: Gemcitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at study sites in the United States (US). The first participant was screened on 02 June 2014. The last study visit occurred on 10 April 2017.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

38 participants were screened.

Data submitted represent analysis performed on data collected in the lead-in phase by the Study Termination Date, 10 April 2017. The study was discontinued before initiation of the randomized treatment phase, therefore no data were collected for the randomized treatment phase.


Reporting Groups
  Description
MMB Dose Level 1 Momelotinib (MMB) 100 mg tablet once daily + albumin-bound (nab)-paclitaxel plus gemcitabine (nab-P+G) (1000+1000 mg/m^2) intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 2 MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 3 MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 4 MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 5 MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle

Participant Flow:   Overall Study
    MMB Dose Level 1   MMB Dose Level 2   MMB Dose Level 3   MMB Dose Level 4   MMB Dose Level 5
STARTED   7   4   7   3   4 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   7   4   7   3   4 
Death                4                3                6                0                3 
Withdrew Consent from study                1                1                0                2                0 
Lost to Follow-up                1                0                0                0                0 
Study Terminated by Sponsor                1                0                1                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Enrolled Analysis Set: all participants who received a study participant identification number in the study after screening.

Reporting Groups
  Description
MMB Dose Level 1 MMB 100 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 2 MMB 150 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 3 MMB 200 mg tablet once daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 4 MMB 150 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
MMB Dose Level 5 MMB 200 mg tablet twice daily + nab-P+G (1000+1000 mg/m^2) IV infusion on Days 1, 8, and 15 of each 28-day cycle
Total Total of all reporting groups

Baseline Measures
   MMB Dose Level 1   MMB Dose Level 2   MMB Dose Level 3   MMB Dose Level 4   MMB Dose Level 5   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   4   7   3   4   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.9  (12.32)   63.5  (12.12)   64.7  (8.79)   52.0  (5.00)   59.0  (9.13)   60.7  (10.21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      2  28.6%      3  75.0%      2  28.6%      0   0.0%      1  25.0%      8  32.0% 
Male      5  71.4%      1  25.0%      5  71.4%      3 100.0%      3  75.0%      17  68.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
           
Asian      0   0.0%      0   0.0%      1  14.3%      0   0.0%      0   0.0%      1   4.0% 
White      6  85.7%      3  75.0%      6  85.7%      3 100.0%      4 100.0%      22  88.0% 
Other      1  14.3%      1  25.0%      0   0.0%      0   0.0%      0   0.0%      2   8.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      1  14.3%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   4.0% 
Not Hispanic or Latino      6  85.7%      4 100.0%      7 100.0%      3 100.0%      4 100.0%      24  96.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
           
United States   7   4   7   3   4   25 


  Outcome Measures

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

2.  Primary:   Randomized Treatment Phase: Overall Survival (OS)   [ Time Frame: Baseline up to the Date of Death or Censoring ]

3.  Secondary:   Lead-In Phase: Overall Survival (OS)   [ Time Frame: Baseline up to the Date of Death or Censoring ]

4.  Secondary:   Lead-In Phase: Progression-Free Survival (PFS)   [ Time Frame: Baseline up to the Date of Event or Censoring ]

5.  Secondary:   Lead-In Phase: Overall Response Rate (ORR)   [ Time Frame: Baseline up to the Last Tumor Assessment Date ]

6.  Secondary:   Randomized Treatment Phase: Progression-Free Survival (PFS)   [ Time Frame: Baseline up to the Date of Event or Censoring ]

7.  Secondary:   Randomized Treatment Phase: Overall Response Rate   [ Time Frame: Baseline up to the Last Tumor Assessment Date ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Study Information Center
Organization: Gilead Sciences
phone: 1-833-445-3230 (GILEAD-0)
e-mail: GileadClinicalTrials@gilead.com



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 Submitted: March 28, 2014
First Posted: April 1, 2014
Results First Submitted: April 6, 2018
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018