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.
20 Years
N/A
Both
Cancer
Trial Information
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.
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. Dose escalation of GSK2118436
will be performed according to a standard 3+3 dose-escalation design. GSK2118436 is given
twice a day. However, to characterize the PK of GSK2118436 and its metabolites after
single-dose administration, GSK2118436 will NOT be administrated for a week after the first
administration. GSK2118436 continuous dosing will start after the 168-hour PK sample is
obtained. Subjects may receive study treatment until disease progression, death or an
unacceptable adverse event.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with adverse events as a measure of safety and tolerability
Outcome Description:
Adverse Events will be graded by the investigator according to the NCI-CTCAE (version 4.0)
Outcome Time Frame:
First 28 days for Dose-limiting toxicity, Adverse Events for 1 year
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
116056
NCT ID:
NCT01582997
Start Date:
May 2012
Completion Date:
July 2013
Related Keywords:
- Cancer
- BRAF
- Advance solid tumors
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