Trial Outcomes & Findings for Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation (NCT NCT01682213)

Last Updated: 2020-05-26

Results Overview

Relapse free survival is defined as the time from surgical resection to the first recurrence or death as assessed by physical examination and radiographic evaluation. All recurrences will be confirmed by biopsy and histologic evaluation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

24 months

Results posted on

2020-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Dabrafenib This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dabrafenib This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabrafenib n=23 Participants This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
Age, Continuous	54 years n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	23 Participants n=99 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 2 participants withdrew consent 1 week after signing consent

Outcome measures

Outcome measures
Measure	Dabrafenib n=21 Participants This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
Percentage of Participants With Relapse Free Survival	28.6 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: 2 participants withdrew consent 1 week after signing consent

Overall survival is defined as the time from surgical resection to death or last follow-up.

Outcome measures

Outcome measures
Measure	Dabrafenib n=21 Participants This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
Overall Survival	78 percentage of participants Interval 51.0 to 91.0

SECONDARY outcome

Timeframe: 1 year

Toxicity will be graded by the NCI Common Toxicity Criteria (CTC) version 4.0 with each cycle of adjuvant dabrafenib.

Outcome measures

Outcome measures
Measure	Dabrafenib n=23 Participants This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
Number of Participants With Adverse Events	23 Participants

Adverse Events

Dabrafenib

Serious events: 5 serious events

Other events: 23 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Dabrafenib n=23 participants at risk This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.
Blood and lymphatic system disorders Anemia	4.3% 1/23 • 1 year
General disorders Chills	4.3% 1/23 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • 1 year
General disorders Fever	8.7% 2/23 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms ben/mal/unk (inccyst/polyp) Other, spec	13.0% 3/23 • 1 year
Investigations Platelet count decreased	4.3% 1/23 • 1 year
Nervous system disorders Seizure	4.3% 1/23 • 1 year
Investigations White blood cell decreased	4.3% 1/23 • 1 year

Other adverse events

Other adverse events
Measure	Dabrafenib n=23 participants at risk This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation.
Skin and subcutaneous tissue disorders Rash	78.3% 18/23 • 1 year
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • 1 year
Skin and subcutaneous tissue disorders Dry Skin	8.7% 2/23 • 1 year
Skin and subcutaneous tissue disorders Hand-foot syndrome	30.4% 7/23 • 1 year
Skin and subcutaneous tissue disorders Photosensitivity	4.3% 1/23 • 1 year
Skin and subcutaneous tissue disorders Alopecia	21.7% 5/23 • 1 year
Vascular disorders Flushing	13.0% 3/23 • 1 year
Skin and subcutaneous tissue disorders New primary melanoma	4.3% 1/23 • 1 year
Nervous system disorders Abducens nerve disorder	4.3% 1/23 • 1 year
Nervous system disorders Syncope	4.3% 1/23 • 1 year
Nervous system disorders Neuropathy	8.7% 2/23 • 1 year
Eye disorders Photophobia	4.3% 1/23 • 1 year
Eye disorders Blurred vision	8.7% 2/23 • 1 year
Nervous system disorders Headache	34.8% 8/23 • 1 year
Gastrointestinal disorders Diarrhea	17.4% 4/23 • 1 year
Gastrointestinal disorders Nausea/Vomiting	17.4% 4/23 • 1 year
Gastrointestinal disorders Dyspepsia	4.3% 1/23 • 1 year
Nervous system disorders Dysgeusia	4.3% 1/23 • 1 year
Metabolism and nutrition disorders Anorexia	8.7% 2/23 • 1 year
Blood and lymphatic system disorders Anemia	17.4% 4/23 • 1 year
Metabolism and nutrition disorders Hypophosphatemia	17.4% 4/23 • 1 year
Investigations Leukopenia	21.7% 5/23 • 1 year
Investigations Transaminitis	4.3% 1/23 • 1 year
General disorders Fatigue	56.5% 13/23 • 1 year
Musculoskeletal and connective tissue disorders Myalgia	34.8% 8/23 • 1 year
Respiratory, thoracic and mediastinal disorders Sore throat	4.3% 1/23 • 1 year
General disorders Pyrexia	30.4% 7/23 • 1 year
Psychiatric disorders Insomnia	4.3% 1/23 • 1 year
General disorders Chills	17.4% 4/23 • 1 year

Additional Information

Dr. Paul Chapman, MD

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