Last updated: 11/03/2018 18:53:29
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 GSK Clinical Study Register is no longer maintained for this study.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.
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic profile of of GSK2118436 in Japanese Subjects With BRAF Mutation Positive Solid Tumors
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: An open-label, dose escalation, phase I study to evaluate the safety, tolerability and pharmacokinetic profile of GSK2118436 in Japanese subjects with BRAF V600 mutation positive solid tumors
Trial description: BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive solid tumors using continuous daily dosing schedule.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events as a measure of safety and tolerability
Timeframe: First 28 days for Dose-limiting toxicity, Adverse Events for 1 year
Secondary outcomes:
Pharmacokinetics (PK) parameters of GSK2118436 and its metabolites including blood concentration, Cmax and AUC
Timeframe: For 1 year
Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: For 1 year
Serum levels of cytokines
Timeframe: For 1 year
Expression levels of pERK and Ki67 in tumor tissues if possible
Timeframe: For 1 year
Gene mutation in tumor tissues, including BRAF and KRAS
Timeframe: For 1 year
Interventions:
Drug: GSK2118436
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
2014-01-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer
Product
dabrafenib
Collaborators
Not applicable
Study date(s)
May 2012 to April 2015
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to standard therapies or for which there is no approved or curative therapy.
- Subjects must have BRAF V600E or K mutant positive tumors.
- Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
- Use of an investigational anti-cancer drug within 28 days preceding the first dose of GSK2118436.
Inclusion and exclusion criteria
Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to standard therapies or for which there is no approved or curative therapy.
- Subjects must have BRAF V600E or K mutant positive tumors.
- Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
- Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
- Must have adequate organ function.
- Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Exclusion criteria:
- Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
- Use of an investigational anti-cancer drug within 28 days preceding the first dose of GSK2118436.
- A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- History of Human Immunodeficiency Virus (HIV) infection.
- Certain cardiac abnormalities.
- Pregnant or lactating female.
Trial location(s)
Study documents
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
2014-01-08
Actual study completion date
2015-16-04
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 116056 can be found on the GSK Clinical Study Register.
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