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A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01373164
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Neoplasms
Neoplasm Metastasis
Pancreatic Cancer
Interventions: Drug: Galunisertib
Drug: Gemcitabine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Completers included participants who died from any cause and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.

Reporting Groups
  Description
Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine

Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 (milligrams per square meter) was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 1b: 160 mg Galunisertib + Gemcitabine

Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 1b: 300 mg Galunisertib + Gemcitabine

Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 2: 300 mg Galunisertib + Gemcitabine

Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 2: Placebo + Gemcitabine

Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.


Participant Flow:   Overall Study
    Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine   Phase 1b: 160 mg Galunisertib + Gemcitabine   Phase 1b: 300 mg Galunisertib + Gemcitabine   Phase 2: 300 mg Galunisertib + Gemcitabine   Phase 2: Placebo + Gemcitabine
STARTED   5   4   5   104   52 
Received at Least One Dose   5   4   5   103   52 
COMPLETED   5   3   4   92   50 
NOT COMPLETED   0   1   1   12   2 
Lost to Follow-up                0                0                1                2                0 
Withdrawal by Subject                0                1                0                10                2 



  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 participants who received at least one dose of study drug.

Reporting Groups
  Description
Phase 1b: 80 mg Galunisertib + Gemcitabine

Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 1b: 160 mg Galunisertib + Gemcitabine

Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 1b: 300 mg Galunisertib + Gemcitabine

Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 2: 300 mg Galunisertib + Gemcitabine

Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.

Phase 2: Placebo + Gemcitabine

Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).

Gemcitabine at a dose of 1000 mg/m^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. participants may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.

Total Total of all reporting groups

Baseline Measures
   Phase 1b: 80 mg Galunisertib + Gemcitabine   Phase 1b: 160 mg Galunisertib + Gemcitabine   Phase 1b: 300 mg Galunisertib + Gemcitabine   Phase 2: 300 mg Galunisertib + Gemcitabine   Phase 2: Placebo + Gemcitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   5   103   52   169 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (12.9)   63.8  (9.0)   56.6  (9.2)   67.3  (8.2)   66.3  (8.9)   63.5  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female   0   3   3   46   24   76 
Male   5   1   2   57   28   93 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino   0   0   1   0   0   1 
Not Hispanic or Latino   5   4   4   37   18   68 
Unknown or Not Reported   0   0   0   66   34   100 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native   0   0   0   0   0   0 
Asian   0   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0 
Black or African American   2   0   0   0   0   2 
White   3   4   5   95   50   157 
More than one race   0   0   0   0   0   0 
Unknown or Not Reported   0   0   0   8   2   10 
Region of Enrollment 
[Units: Participants]
Count of Participants
           
Belgium   0   0   0   4   2   6 
United States   5   2   1   7   4   19 
Italy   0   0   0   23   10   33 
France   0   0   0   21   9   30 
Germany   0   0   0   22   14   36 
Spain   0   2   4   26   13   45 


  Outcome Measures

1.  Primary:   Phase 1b: Recommended Phase 2 Dose   [ Time Frame: Time of first phase 1b dose until time of last phase 1b dose (up to 1 year) ]

2.  Primary:   Phase 2: Overall Survival (OS)   [ Time Frame: Baseline to date of death from any cause (up to 2 years) ]

3.  Secondary:   Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)   [ Time Frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) ]

4.  Secondary:   Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)   [ Time Frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) ]

5.  Secondary:   Phase 1b: Number of Participants With Tumor Response   [ Time Frame: Baseline to end of Phase 1b (up to 1 year) ]

6.  Secondary:   Phase 2: Progression Free Survival (PFS)   [ Time Frame: Baseline to first date of progressive disease or death due to any cause (up to 2 years) ]

7.  Secondary:   Phase 2: Percentage Change From Baseline in Tumor Size (CTS)   [ Time Frame: Baseline, end of Cycle 2 (up to 56 days) ]

8.  Secondary:   Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])   [ Time Frame: Baseline to measured progressive disease (up to 2 years) ]

9.  Secondary:   Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])   [ Time Frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) ]

10.  Secondary:   Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib   [ Time Frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) ]

11.  Secondary:   Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion   [ Time Frame: Baseline, study treatment completion (up to 1 year) ]

12.  Secondary:   Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up   [ Time Frame: Baseline, study treatment completion after first follow up visit (up to 1 year) ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979
e-mail: ClinicalTrials.gov@lilly.com



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01373164     History of Changes
Other Study ID Numbers: 13663
H9H-MC-JBAJ ( Other Identifier: Eli Lilly and Company )
First Submitted: June 9, 2011
First Posted: June 14, 2011
Results First Submitted: February 23, 2018
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018