Trial Outcomes & Findings for Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer (NCT NCT00525135)

NCT ID: NCT00525135

Last Updated: 2015-02-03

Results Overview

Number of participants with decreased thyroglobulin level after study treatment

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Baseline, 16 weeks
• Results posted on: 2015-02-03

Participant Flow

Participant milestones

Measure	Study Intervention Patients receive valproic acid daily for 16 weeks.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer

Baseline characteristics by cohort

Measure	Study Intervention n=5 Participants Patients receive valproic acid daily for 16 weeks.
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks

Number of participants with decreased thyroglobulin level after study treatment

Outcome measures

Measure	Study Intervention n=5 Participants Patients receive valproic acid daily for 16 weeks.
Decrease in Thyroglobulin Level	0 participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks

Number of participants with decreased tumor size after study treatment

Outcome measures

Measure	Study Intervention n=5 Participants Patients receive valproic acid daily for 16 weeks.
Decrease in Tumor Size	0 participants

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy

Outcome measures

Measure	Study Intervention n=5 Participants Patients receive valproic acid daily for 16 weeks.
Increased Radioactive Iodine Uptake	3 participants

SECONDARY outcome

Timeframe: 17 weeks

Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment

Outcome measures

Measure	Study Intervention n=5 Participants Patients receive valproic acid daily for 16 weeks.
Side Effects of Drugs Affecting Quality of Life	0 participants

SECONDARY outcome

Timeframe: up to 10 years post-study treatment

Population: Due to early termination, participants were not followed for survival after the primary outcome timeframe

Outcome measures

Outcome data not reported

Adverse Events

Study Intervention

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

UCSF PRS Administrator

University of California San Francisco

Phone: 415-502-3212

Email: Elaine.Cooperstein@ucsf.edu

Results disclosure agreements

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