RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy

PHASE2TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

July 16, 2015

Primary Completion Date

May 10, 2016

Study Completion Date

May 25, 2016

Conditions
Cholangiocarcinoma
Interventions
DRUG

RRx-001

RRx-001 (10 mg/m2) intravenously twice weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 30 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression

DRUG

Gemcitabine and cisplatin

RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression

Trial Locations (1)

21287

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EpicentRx, Inc.

INDUSTRY