Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

March 31, 2015

Study Completion Date

June 30, 2015

Conditions
Rectal Cancer
Interventions
DRUG

capecitabine + ganetespib

"Capecitabine will be started on Day 1 of the concurrent chemo-radiation phase at the specified dose, and is given orally twice daily for the entire duration of radiation therapy.~Ganetespib will be started on Day 1 of radiation therapy and is administered as IV infusion over 1 hour on days 1, 8, 15 for cycle 1 and then on days 29 and 36 for cycle 2.~In all patients, ganetespib monotherapy will be given up to 2 weeks prior to start of concurrent chemoradiation. Sequential biopsies will be taken at baseline and prior to the start of concurrent chemoradiation. In the dose escalation part of the study, the starting does of ganetespib is 60mg/m² once weekly, and capecitabine at a dose of 825 mg/m² twice daily."

Trial Locations (1)

30322

Emory University Winship Cancer Institute, Atlanta

All Listed Sponsors
collaborator

Synta Pharmaceuticals Corp.

INDUSTRY

lead

Emory University

OTHER

NCT01554969 - Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer | Biotech Hunter | Biotech Hunter