Trial Outcomes & Findings for Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation (NCT NCT01474551)

Last Updated: 2015-11-18

Results Overview

The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

2 years

Results posted on

2015-11-18

Participant Flow

Protocol Open to Accrual: 11/15/2011 Protocol Closed to Accrual: 03/12/2013 Primary Completion Date (if applicable): 03/12/2013 Recruitment Location is the medical clinic

Participant milestones

Participant milestones
Measure	Vemurafenib This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery. Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vemurafenib This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery. Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Overall Study Death	1

Baseline Characteristics

Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vemurafenib n=2 Participants This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery. Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Vemurafenib n=1 Participants This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery. Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Overall Objective Response Stable Disease	1 participants
Overall Objective Response Complete Response	0 participants
Overall Objective Response Partial Response	0 participants
Overall Objective Response Progression of Disease	0 participants

Adverse Events

Vemurafenib

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vemurafenib n=2 participants at risk This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery. Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Investigations Creatinine increase	50.0% 1/2 • Number of events 1
General disorders Death NOS	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hyperkalemia	50.0% 1/2 • Number of events 1

Other adverse events

Other adverse events
Measure	Vemurafenib n=2 participants at risk This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery. Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Investigations Blood bilirubin increased	50.0% 1/2 • Number of events 1
Investigations Creatinine increased	50.0% 1/2 • Number of events 3
Metabolism and nutrition disorders Hyperglycemia	50.0% 1/2 • Number of events 8
Metabolism and nutrition disorders Hyperkalemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 1/2 • Number of events 14
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hyponatremia	50.0% 1/2 • Number of events 6
Investigations INR increased	50.0% 1/2 • Number of events 1
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 1
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 1/2 • Number of events 1

Additional Information

Dr. Paul Chapman

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place