Trial Outcomes & Findings for Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma (NCT NCT00673361)

Last Updated: 2016-01-13

Results Overview

Terminated study before accrual goal, no data analysis

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

3 weeks, 6 weeks, 16 weeks, & 24 weeks

Results posted on

2016-01-13

Reasons for withdrawal
Measure	"Chemo-Switch" Regimen
Overall Study Screen Failure	2

Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma

Baseline characteristics by cohort
Measure	"Chemo-Switch" Regimen n=9 Participants
Age, Customized	9 participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

Timeframe: 3 weeks, 6 weeks, 16 weeks, & 24 weeks

Terminated study before accrual goal, no data analysis

Outcome data not reported

Timeframe: post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Duke University Medical Center

Phone: 919-681-3480