Last updated: 11/03/2018 15:11:33
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination with Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or nab-Paclitaxel
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination with Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or nab-Paclitaxel in Subjects with Advanced Solid Tumors
Trial description: The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination
Timeframe: Duration of study (approximately 3 years)
Secondary outcomes:
To characterize population pharmacokinetic parameters
Timeframe: Duration of study (approximately 3 years)
To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1
Timeframe: Duration of study (approximately 3 years)
Interventions:
Enrollment:
169
Primary completion date:
2013-07-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer
Product
trametinib
Collaborators
Not applicable
Study date(s)
September 2010 to October 2013
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
- Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
- The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
- The subject has a brain tumor.
Inclusion and exclusion criteria
Inclusion criteria:
- The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
- Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
- The subject has a radiographically measurable tumor.
- The subject is able to carry out daily life activities without difficulty.
- The subject is able to swallow and retain oral medication.
- The subject does not have significant side effects from previous anti-cancer treatment.
- The subject has adequate organ and blood cell counts.
- Sexually active subjects must use medically acceptable methods of contraception during the course of the study.
Exclusion criteria:
- The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
- The subject has a brain tumor.
- Current severe, uncontrolled systemic disease.
- History of clinically significant heart, lung, or eye/vision problems.
- The subject has high blood pressure that is not well-controlled with medication.
- The subject has a permanent pacemaker.
- The subject is pregnant or breastfeeding.
- Positive for Hepatitis B, Hepatitis C, or HIV.
Trial location(s)
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95817
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89169
Status
Study Complete
Location
GSK Investigational Site
Vancouver, Washington, United States, 98684
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29605
Status
Terminated/Withdrawn
Showing 1 - 6 of 19 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
2013-07-10
Actual study completion date
2013-07-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 113486 can be found on the GSK Clinical Study Register.
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