Trial Outcomes & Findings for A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma (NCT NCT02050321)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

6 months post treatment

Results posted on

2018-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	Acitretin and Vemurafenib Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose. Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Acitretin and Vemurafenib Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose. Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1

Baseline Characteristics

A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acitretin and Vemurafenib n=2 Participants Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose. Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	53.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post treatment

Population: Per the PI: There is no measurable or interpretable data for this study. Only two patients were enrolled before the study closed to accrual due to recent FDA approvals of drugs for melanoma.Patients were removed from protocol prior to reaching data points or the completing the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 30 Days post Treatment

Population: Per the PI: Although there is no measurable or interpretable data for this study. One patient had higher than normal liver lab results and was removed from study treatment due to grade and severity. Patient safety was evaluated.

The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Outcome measures
Measure	Acitretin and Vemurafenib n=2 Participants Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose. Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Number of Participants With Adverse Events	1 Participants

Adverse Events

Acitretin and Vemurafenib

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Acitretin and Vemurafenib n=2 participants at risk Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose. Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
Respiratory, thoracic and mediastinal disorders Respiatory Infection	50.0% 1/2 • Number of events 1 • SAEs were collected on Day 1 and Day 15 of each of the 3 cycles. End of Treatment or Early Term SAEs were collected 30 days after the last dose of study drug.
Hepatobiliary disorders Elevated Liver Values	50.0% 1/2 • Number of events 1 • SAEs were collected on Day 1 and Day 15 of each of the 3 cycles. End of Treatment or Early Term SAEs were collected 30 days after the last dose of study drug.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lee Cranmer

University of Arizona Cancer Center

Phone: 520 626-0501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place