GSK1120212+GSK2141795 for Cervical Cancer
|ClinicalTrials.gov Identifier: NCT01958112|
Recruitment Status : Terminated (Drug supply)
First Posted : October 8, 2013
Last Update Posted : August 21, 2017
This research study is evaluating the combination of two drugs called GSK1120212 (trametinib) and GSK2141795 as a possible treatment for recurrent or persistent cervical cancer. Trametinib and GSK2141795 are drugs that may stop cancer cells from growing. Trametinib is a MEK inhibitor - it blocks a protein called MEK that is commonly overactive in tumor cells. GSK2141795 is an AKT inhibitor which blocks a pathway in cancer cells that is commonly overactive in tumor cells called the PI3kinase pathway. In this research study, the investigator is looking to see whether the combination of Trametinib and GSK2141795 is useful in treating recurrent and persistent cervical cancer.
Additionally, the investigator is looking to see if participants whose tumors contain a particular genetic make-up will have better response to combination trametinib and GSK2141795. Participants' tumors will be tested for mutations in genes which could make some cancers more susceptible to trametinib and GSK2141795.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: GSK1120212 (trametinib) Drug: GSK2141795||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Single Stage Phase II Trial of GSK1120212 and GSK2141795 in Persistent or Recurrent Cervical Cancer|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2020|
Experimental: GSK1120212 (trametinib) and GSK2141795
GSK1120212 (trametinib) 1.5 mg QD + GSK2141795 50 mg QD in 28 day cycles
Drug: GSK1120212 (trametinib)
Trametinib dose is 1.5 mg orally once per day
Other Name: Trametinib
The dose of GSK2141795 is 50 mg orally once per day
- Response Rate for the combination of GSK1120212 (trametinib) and GSK2141795 in patients with recurrent or persistent cervical cancer. [ Time Frame: 2 Years ]Response rate will be assessed by RECIST version 1.1.
- Duration of progression-free (PFS) [ Time Frame: 2 Years ]The duration of progression-free (PFS) following initiation of therapy with GSK1120212 (trametinib) and GSK2141795 will be measured.
- Toxicity of GSK1120212 (trametinib) and GSK2141795. [ Time Frame: 2 Years ]Toxicity will be assessed for this combination by version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) in this cohort of patients.
- 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. [ Time Frame: 2 Years ]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.
- Association of mutational status with clinical benefit from GSK1120212 (trametinib) and GSK2141795. [ Time Frame: 2 Years ]The association of mutational status along with clinical benefit from GSK1120212 (trametinib) and GSK2141795 will be explored in this study.
- Overall survival [ Time Frame: 2 years ]Overall survival will be determined for subjects on this study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958112
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Ursula A. Matulonis, MD||Dana-Farber Cancer Institute|