Phase 2
N=92
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01153763 ↗Enrolled (actual)
92
Serious AEs
35.9%
Results posted
Jun 2014
Primary outcome: Primary: Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation — 5; 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK2118436 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation |
5; 40 | — |
| SECONDARY Number of Participants With a Best Overall Response of CR or PR as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation |
0; 2 | — |
| SECONDARY Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation |
6.3 | — |
| SECONDARY Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation |
4.0 | — |
| SECONDARY Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation |
6.6 | — |
| SECONDARY Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation |
5.6 | — |
| SECONDARY Overall Survival for Participants Who Had a BRAF V600E Mutation |
13.1 | — |
| SECONDARY Overall Survival for Participants Who Had a BRAF V600K Mutation |
12.9 | — |
| SECONDARY Number of Participants With AEs and Serious Adverse Events (SAEs) |
87; 33 | — |
| SECONDARY Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades |
23; 18; 18; 3; 11; 51 | — |
| SECONDARY Number of Participants With Change From Baseline in Temperature and Pulse Rate |
3; 84; 4; 9; 66; 16 | — |
| SECONDARY Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
32; 6; 2; 7 | — |
| SECONDARY Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels |
34; 54 | — |
Summary
BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years of age
- Must have histologically confirmed cutaneous metastatic melanoma (Stage IV) that is BRAF mutation-positive (V600 E/K) as determined via central testing with a BRAF mutation assay.
- Is treatment naive or has received prior treatment for metastatic melanoma.
- Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment.
- 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 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Adequate organ function.
Exclusion Criteria
- Previous treatment with a BRAF or MEK inhibitor.
- Cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of GSK2118436.
- A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
- History or evidence of brain metastases on MRI or head CT if MRI is not able to be performed.
- History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Certain cardiac abnormalities.
Data sourced from ClinicalTrials.gov (NCT01153763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.