Trial Outcomes & Findings for Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases (NCT NCT02974803)

NCT ID: NCT02974803

Last Updated: 2021-08-20

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

24 months

Results posted on

2021-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Dabrafenib and Trametinib Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously Dabrafenib Trametinib
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabrafenib and Trametinib n=6 Participants Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously Dabrafenib Trametinib
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The study was closed early because of very slow accrual and no final analysis was performed because the collected data cannot be considered reliable since they were not verified, reviewed or cleaned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The study was closed early because of very slow accrual and no final analysis was performed because the collected data cannot be considered reliable since they were not verified, reviewed or cleaned.

Response will be assessed using RECIST v1.1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The study was closed early because of very slow accrual and no final analysis was performed because the collected data cannot be considered reliable since they were not verified, reviewed or cleaned.

Response will be assessed using RECIST v1.1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The study was closed early because of very slow accrual and no final analysis was performed because the collected data cannot be considered reliable since they were not verified, reviewed or cleaned.

Response will be assessed using RECIST v1.1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: The study was closed early because of very slow accrual and no final analysis was performed because the collected data cannot be considered reliable since they were not verified, reviewed or cleaned.

Response will be assessed using RECIST v1.1

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The study was closed early because of very slow accrual and no final analysis was performed because the collected data cannot be considered reliable since they were not verified, reviewed or cleaned.

Response will be assessed using RECIST v1.1

Outcome measures

Outcome data not reported

Adverse Events

Dabrafenib and Trametinib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lesely Seymour

Canadian Cancer Trials Group

Phone: 6135336430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place