Trial Outcomes & Findings for RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy (NCT NCT02452970)

Last Updated: 2024-04-24

Results Overview

Overall objective response (RECIST)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Baseline and every 6-8 weeks while on treatment until progression. Estimated 8 -24 weeks.

Results posted on

2024-04-24

Participant milestones
Measure	RRx-001 the Cisplatin and Gemcitabine Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with 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 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 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
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	RRx-001 the Cisplatin and Gemcitabine Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with 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 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 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
Overall Study Adverse Event	1

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

Baseline characteristics by cohort
Measure	RRx-001 the Cisplatin and Gemcitabine n=4 Participants Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with 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 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 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
Age, Continuous	65.5 years STANDARD_DEVIATION 5.8 • n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=99 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=99 Participants
Race/Ethnicity, Customized White	2 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants

Timeframe: Baseline and every 6-8 weeks while on treatment until progression. Estimated 8 -24 weeks.

Overall objective response (RECIST)

Outcome measures
Measure	RRx-001 the Cisplatin and Gemcitabine n=3 Participants Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with 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 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 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
Overall Objective Response (RECIST)	3 Participants

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events
Measure	RRx-001 the Cisplatin and Gemcitabine n=4 participants at risk Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with 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 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 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
Cardiac disorders Cardiac failure congestive	25.0% 1/4 • Number of events 1
Hepatobiliary disorders Cholangitis	25.0% 1/4 • Number of events 1

Other adverse events
Measure	RRx-001 the Cisplatin and Gemcitabine n=4 participants at risk Patients with advanced and metastatic biliary tract adenocarcinoma (cholangiocarcinoma) who had been treated with and failed first-line chemotherapy will be treated with 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 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 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
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Number of events 1
Cardiac disorders Cardiac failure congestive	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Stomatitis	25.0% 1/4 • Number of events 1
Hepatobiliary disorders Cholangitis	25.0% 1/4 • Number of events 1
Investigations Liver function test abnormal	25.0% 1/4 • Number of events 1
Investigations Platelet count decreased	25.0% 1/4 • Number of events 1
Renal and urinary disorders Renal Impairment	25.0% 1/4 • Number of events 1
Vascular disorders Embolism	25.0% 1/4 • Number of events 1

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