A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)
Phase 3
Completed
- Conditions
- melanoma10040900
- Registration Number
- NL-OMON44057
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
* Subjects with histologically confirmed advanced or metastatic melanoma
* Treatment naïve for metastatic disease (with the exception of IL-2, which will be allowed).
* BRAF V600 mutation positive.
* Measurable disease.
* 18 years and above.
* ECOG Performance Status 0-1.
* Females of childbearing potential: double barrier method of contraception.
Exclusion Criteria
* Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
* Known ocular or primary mucosal melanoma.
* Currently receiving cancer therapy.
* Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
* Evidence of active CNS disease.
* Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression-free survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, best overall response, duration of response, non-melanoma<br /><br>skin lesions, second malignancies, further validation of a BRAF mutation assay,<br /><br>quality of life, safety, tolerability, PK, translational research.</p><br>