Trial Outcomes & Findings for A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression (NCT NCT00718770)

Results Overview

To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

10 participants

Primary outcome timeframe

1 year

Results posted on

2014-01-17

Participant Flow

Patients were recruited from a medical clinic from 01/15/2009 to 01/14/2010

The patients must fit all inclusion criteria and have had a 4 week washout from any systemic or radiation therapy. As an open-label, single arm trial, there was no group assignment. Patients were excluded only if they did not meet inclusion or had exclusion criteria

Participant milestones

Participant milestones
Measure	Bexarotene Open label - all patients received the intervention Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2.
Overall Study STARTED	10
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Bexarotene Open label - all patients received the intervention Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2.
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

A Pilot Clinical Trial for Poorly Differentiated Thyroid Cancer - Correlation to Retinoid and Peroxisome-proliferator-activated Receptor (PPARy) Expression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bexarotene n=10 Participants Open label - all patients receive intervention Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Adults with radioiodine resistant metastatic follicular cell derived thyroid cancer

To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria

Outcome measures

Outcome measures
Measure	Bexarotene n=10 Participants Open label - all patients receive intervention Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
Change in Tumor Size	4.7 cm Standard Deviation 0.2

Adverse Events

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

Other adverse events
Measure	Bexarotene n=10 participants at risk Open label - all patients receive intervention Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2.
Blood and lymphatic system disorders hyperlipidemia	40.0% 4/10 • Number of events 4 • 1 year

Additional Information

Joshua Klopper, MD

University of Colorado School of Medicine

Phone: 303-724-3921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place