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GSK1120212+GSK2141795 for Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01958112
Recruitment Status : Terminated (Drug supply)
First Posted : October 8, 2013
Results First Posted : January 1, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
Novartis
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Ursula A. Matulonis, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Cancer
Interventions Drug: GSK1120212 (trametinib)
Drug: GSK2141795
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
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GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
Hide Arm/Group Description

GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  64.3%
>=65 years
5
  35.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Response Rate for the Combination of GSK1120212 (Trametinib) and GSK2141795 in Patients With Recurrent or Persistent Cervical Cancer.
Hide Description Response rate will be assessed by RECIST version 1.1.
Time Frame 2 Years
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Response rate assessed by RECIST version 1.1.
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
Hide Arm/Group Description:

GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
1
   7.1%
Stable Disease
8
  57.1%
Unevaluable
2
  14.3%
Progressive Disease
3
  21.4%
2.Secondary Outcome
Title Duration of Progression-free (PFS)
Hide Description The duration of progression-free (PFS) following initiation of therapy with GSK1120212 (trametinib) and GSK2141795 will be measured.
Time Frame 2 Years
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PFS events were determined by RECIST 1.1, clinical progression and death.
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
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GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
3.7 [1] 
(1.9 to NA)
[1]
Study was stopped prematurely, insufficient number of participants with events.
3.Secondary Outcome
Title Toxicity of GSK1120212 (Trametinib) and GSK2141795 as Measured by the Number of Participants With Adverse Events
Hide Description Toxicity was assessed for this combination by version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) in this cohort of patients. Toxicities reported were deemed related to study treatment.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
Hide Arm/Group Description:

GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
14
 100.0%
4.Secondary Outcome
Title Mutation and Co-mutation Rates of Genes in the PI3K and RAS ERK Signaling Pathways in Recurrent Cervical Cancer Using High Throughput Targeted Mutational Analysis on Participant Tumor Samples.
Hide Description The mutation and co-mutation rates of genes in the PI3K and RAS ERK signaling pathways in recurrent cervical cancer will be interrogated using high throughput targeted mutational analysis on participant tumor samples.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Observed mutations and amplifications in genes related to PI3K or RAS signaling in the 13 patients with tissue available for testing. One patient did not have archival tissue available for testing, five patients did not have detected alterations.
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
Hide Arm/Group Description:

GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Adenocarcinoma Number Analyzed 5 participants
PIK3CA mutation
2
  40.0%
PIK3CA amplification
1
  20.0%
KRAS abberation
2
  40.0%
Squamous Cell Carcinoma Number Analyzed 2 participants
PIK3CA mutation
2
 100.0%
PIK3CA amplification
0
   0.0%
KRAS abberation
0
   0.0%
Mucinous Number Analyzed 1 participants
PIK3CA mutation
0
   0.0%
PIK3CA amplification
0
   0.0%
KRAS abberation
1
 100.0%
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival will be determined for subjects on this study
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
Hide Arm/Group Description:

GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
14.8 [1] 
(6.7 to NA)
[1]
Study stopped prematurely, insufficient number of participants with events.
Time Frame 2 years, 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1120212 (Trametinib) and GSK2141795
Hide Arm/Group Description

GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles

GSK1120212 (trametinib): Trametinib dose is 1.5 mg orally once per day

GSK2141795: The dose of GSK2141795 is 50 mg orally once per day

All-Cause Mortality
GSK1120212 (Trametinib) and GSK2141795
Affected / at Risk (%)
Total   8/14 (57.14%)    
Show Serious Adverse Events Hide Serious Adverse Events
GSK1120212 (Trametinib) and GSK2141795
Affected / at Risk (%) # Events
Total   3/14 (21.43%)    
Blood and lymphatic system disorders   
Thromboembolic event *  2/14 (14.29%)  2
Eye disorders   
Retinal pigment epithelial detachment *  1/14 (7.14%)  1
Gastrointestinal disorders   
colonic perforation *  1/14 (7.14%)  1
Investigations   
Hypophosphatemia *  1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK1120212 (Trametinib) and GSK2141795
Affected / at Risk (%) # Events
Total   1/14 (7.14%)    
Skin and subcutaneous tissue disorders   
rash acneiform *  1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: Dr. Ursula Matulonis
Organization: Dana-Farber Cancer Institute
Phone: 617-632-2334
Responsible Party: Ursula A. Matulonis, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01958112     History of Changes
Other Study ID Numbers: 13-334
First Submitted: October 4, 2013
First Posted: October 8, 2013
Results First Submitted: December 11, 2018
Results First Posted: January 1, 2019
Last Update Posted: May 31, 2019