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

Primary Purpose

Cholangiocarcinoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RRx-001

Gemcitabine and cisplatin

About this trial

This is an interventional treatment trial for Cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RRx-001 the cisplatin and gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) of patients with advanced or metastatic biliary cancer after retreatment with gemcitabine and cisplatin following treatment with RRx-001

Secondary Outcome Measures

Disease control rate (DCR)

Overall Survival

Number, frequency and type of adverse events

Toxicity of gemcitabine and cisplatin following treatment with RRx-001

Full Information

NCT ID

NCT02452970

First Posted

May 17, 2015

Last Updated

November 13, 2019

Sponsor

EpicentRx, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02452970

Brief Title

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

Acronym

EPIC

Official Title

A Phase 2, Single-Arm, Open-label, Study of RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

Resensitization or clinical benefit was not observed

Study Start Date

July 16, 2015 (Actual)

Primary Completion Date

May 10, 2016 (Actual)

Study Completion Date

May 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EpicentRx, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RRx-001 the cisplatin and gemcitabine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

RRx-001

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine and cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival (PFS) of patients with advanced or metastatic biliary cancer after retreatment with gemcitabine and cisplatin following treatment with RRx-001

Description

Progression-free survival (PFS) of patients with advanced or metastatic biliary cancer after retreatment with gemcitabine and cisplatin following treatment with RRx-001

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Disease control rate (DCR)

Time Frame

Up to 2 years

Title

Overall Survival

Time Frame

Up to 2 years

Title

Number, frequency and type of adverse events

Description

Toxicity of gemcitabine and cisplatin following treatment with RRx-001

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana De Jesus Acosta, MD

Organizational Affiliation

Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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