Trial Outcomes & Findings for Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL (NCT NCT00178841)

NCT ID: NCT00178841

Last Updated: 2016-02-17

Results Overview

mSWAT scoring. Range 0 to 400. Measured every 4 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2016-02-17

Participant Flow

Participant milestones

Measure	Rosiglitazone and Bexarotene Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

Baseline characteristics by cohort

Measure	Single Arm Study n=4 Participants All enrolled patients received rosiglitazone in addition to oral bexarotene
Age, Continuous	53 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

mSWAT scoring. Range 0 to 400. Measured every 4 weeks.

Outcome measures

Measure	Rosiglitazone and Bexarotene n=4 Participants All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
Number of Participants With a 50% Improvement in Baseline Skin Score	0 participants

SECONDARY outcome

Timeframe: baseline and every 4 weeks

FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best

Outcome measures

Measure	Rosiglitazone and Bexarotene n=4 Participants All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
Quality of Life Evaluations	86.25 units on a scale Interval 0.0 to 108.0

SECONDARY outcome

Timeframe: 16 weeks

10-cm visual analog scale, 10= worst, 1=best

Outcome measures

Measure	Rosiglitazone and Bexarotene n=4 Participants All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
Pruritus Score	5.7 units on a scale Interval 0.0 to 10.0

Adverse Events

Rosiglitazone and Bexarotene

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rosiglitazone and Bexarotene n=4 participants at risk All enrolled patients received rosiglitazone in addition to oral bexarotene.
Metabolism and nutrition disorders Hypertriglyceridemia and hypercholesterolemia	100.0% 4/4 • Number of events 4 • 2 years
Blood and lymphatic system disorders Anemia	50.0% 2/4 • Number of events 2 • 2 years
Blood and lymphatic system disorders Neutropenia	75.0% 3/4 • Number of events 3 • 2 years
Blood and lymphatic system disorders Lymphopenia	25.0% 1/4 • Number of events 1 • 2 years

Additional Information

John Zic, MD

Vanderbilt University Dermatology

Phone: 615-322-6485

Email: john.zic@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place