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

NCT02452970 | Terminated Phase 2 Results

• 1 other identifier: RRx001-27-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label study, which means that patients will know what treatments they are receiving, is EPIC, a hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and Cholangiocarcinoma. The study treatment is divided into two stages. During the first stage, patients will receive RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as long as the tumors respond to them to determine whether resensitization has occurred. The primary objective of this clinical trial is to evaluate the progression-free survival (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response (RECIST)

  Overall objective response (RECIST)

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

Study Arms (1)

RRx-001 the cisplatin and gemcitabine

EXPERIMENTAL

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

Drug: RRx-001; Drug: Gemcitabine and cisplatin

Interventions

RRx-001 DRUG

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

RRx-001 the cisplatin and gemcitabine

Gemcitabine and cisplatin DRUG

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 the cisplatin and gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of biliary tract adenocarcinoma/cholangiocarcinoma
• Must have locally advanced or distant metastatic disease that is not surgically curable
• Failed first-line chemotherapy
• Age ≥ 18 years
• Life expectancy of at least 12 weeks (3 months)
• Performance status 0 or 1
• Adequate liver, kidney, and bone marrow function

You may not qualify if:

• Symptomatic metastatic brain or meningeal tumors
• Investigational compound within 4 weeks of enrollment
• History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
• Any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation
• Pregnant or nursing
• Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
• Albumin \<2.8
• Uncontrolled or clinically relevant ascites
• Absolute contraindication for MRI imaging such as intracorporeal metal or pacemaker

Sponsors & Collaborators

• EpicentRx, Inc.: lead

Study Sites (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

RRx-001; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Study Director: Bryan Oronsky, Chief Medical Officer
• Organization: EpicentRx, Inc.

boronsky@epicentrx.com

408-569-3202

Study Officials

• Ana De Jesus Acosta, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: May 25, 2015
• Study Start: July 16, 2015
• Primary Completion: May 10, 2016
• Study Completion: May 25, 2016
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-03

Locations

US (1)