Trial Outcomes & Findings for GSK1120212+GSK2141795 for Cervical Cancer (NCT NCT01958112)
NCT ID: NCT01958112
Last Updated: 2019-05-31
Results Overview
Response rate will be assessed by RECIST version 1.1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
2 Years
Results posted on
2019-05-31
Participant Flow
Participant milestones
| Measure |
GSK1120212 (Trametinib) and GSK2141795
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 Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GSK1120212+GSK2141795 for Cervical Cancer
Baseline characteristics by cohort
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=14 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: Response rate assessed by RECIST version 1.1.
Response rate will be assessed by RECIST version 1.1.
Outcome measures
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=14 Participants
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
|
|---|---|
|
Response Rate for the Combination of GSK1120212 (Trametinib) and GSK2141795 in Patients With Recurrent or Persistent Cervical Cancer.
Complete Response
|
0 Participants
|
|
Response Rate for the Combination of GSK1120212 (Trametinib) and GSK2141795 in Patients With Recurrent or Persistent Cervical Cancer.
Partial Response
|
1 Participants
|
|
Response Rate for the Combination of GSK1120212 (Trametinib) and GSK2141795 in Patients With Recurrent or Persistent Cervical Cancer.
Stable Disease
|
8 Participants
|
|
Response Rate for the Combination of GSK1120212 (Trametinib) and GSK2141795 in Patients With Recurrent or Persistent Cervical Cancer.
Unevaluable
|
2 Participants
|
|
Response Rate for the Combination of GSK1120212 (Trametinib) and GSK2141795 in Patients With Recurrent or Persistent Cervical Cancer.
Progressive Disease
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: PFS events were determined by RECIST 1.1, clinical progression and death.
The duration of progression-free (PFS) following initiation of therapy with GSK1120212 (trametinib) and GSK2141795 will be measured.
Outcome measures
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=11 Participants
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
|
|---|---|
|
Duration of Progression-free (PFS)
|
3.7 months
Interval 1.9 to
Study was stopped prematurely, insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 2 YearsToxicity 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.
Outcome measures
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=14 Participants
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
|
|---|---|
|
Toxicity of GSK1120212 (Trametinib) and GSK2141795 as Measured by the Number of Participants With Adverse Events
|
14 Participants
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: 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.
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.
Outcome measures
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=13 Participants
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
|
|---|---|
|
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.
Adenocarcinoma · PIK3CA mutation
|
2 Participants
|
|
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.
Adenocarcinoma · PIK3CA amplification
|
1 Participants
|
|
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.
Adenocarcinoma · KRAS abberation
|
2 Participants
|
|
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.
Squamous Cell Carcinoma · PIK3CA mutation
|
2 Participants
|
|
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.
Squamous Cell Carcinoma · PIK3CA amplification
|
0 Participants
|
|
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.
Squamous Cell Carcinoma · KRAS abberation
|
0 Participants
|
|
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.
Mucinous · PIK3CA mutation
|
0 Participants
|
|
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.
Mucinous · PIK3CA amplification
|
0 Participants
|
|
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.
Mucinous · KRAS abberation
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOverall survival will be determined for subjects on this study
Outcome measures
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=11 Participants
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 Survival
|
14.8 months
Interval 6.7 to
Study stopped prematurely, insufficient number of participants with events.
|
Adverse Events
GSK1120212 (Trametinib) and GSK2141795
Serious events: 3 serious events
Other events: 1 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=14 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Thromboembolic event
|
14.3%
2/14 • Number of events 2 • 2 years, 2 months
|
|
Gastrointestinal disorders
colonic perforation
|
7.1%
1/14 • Number of events 1 • 2 years, 2 months
|
|
Investigations
Hypophosphatemia
|
7.1%
1/14 • Number of events 1 • 2 years, 2 months
|
|
Eye disorders
Retinal pigment epithelial detachment
|
7.1%
1/14 • Number of events 1 • 2 years, 2 months
|
Other adverse events
| Measure |
GSK1120212 (Trametinib) and GSK2141795
n=14 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash acneiform
|
7.1%
1/14 • Number of events 1 • 2 years, 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60