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Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01231581
First received: August 30, 2010
Last updated: July 25, 2013
Last verified: July 2013
Results First Received: June 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: GSK1120212
Drug: Gemcitabine
Drug: Placebo

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
Trametinib + Gemcitabine Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Placebo + Gemcitabine Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.

Participant Flow:   Overall Study
    Trametinib + Gemcitabine   Placebo + Gemcitabine
STARTED   80   80 
Ongoing   1 [1]   0 
COMPLETED   0   0 
NOT COMPLETED   80   80 
Lost to Follow-up                2                2 
Withdrawal by Subject                6                9 
Study Closed/Terminated                6                5 
Death                65                64 
Ongoing                1                0 
[1] Participant is continuing treatment with trametinib and gemcitabine under roll over study MEK114375.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Trametinib + Gemcitabine Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Placebo + Gemcitabine Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Total Total of all reporting groups

Baseline Measures
   Trametinib + Gemcitabine   Placebo + Gemcitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   80   160 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.3  (10.35)   62.2  (9.56)   62.3  (9.93) 
Gender 
[Units: Participants]
     
Female   41   34   75 
Male   39   46   85 
Race/Ethnicity, Customized 
[Units: Participants]
     
White - White/Caucasian/European Heritage   50   59   109 
Asian - East Asian Heritage   24   13   37 
African American Africa   6   5   11 
Asian - Central/South Asian Heritage   0   1   1 
Asian - South East Asian Heritage   0   1   1 
White - Arabic/North African Heritage   0   1   1 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months) ]

2.  Secondary:   Progression-free Survival (PFS) as Assessed by the Investigator   [ Time Frame: From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months) ]

3.  Secondary:   Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR)   [ Time Frame: From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months) ]

4.  Secondary:   Investigator-Assessed Duration of Response   [ Time Frame: From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months) ]

5.  Secondary:   Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)   [ Time Frame: From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months) ]

6.  Secondary:   Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters   [ Time Frame: From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months) ]

7.  Secondary:   Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements   [ Time Frame: From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01231581     History of Changes
Other Study ID Numbers: 113487
Study First Received: August 30, 2010
Results First Received: June 20, 2013
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration