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

Sponsor
EpicentRx, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02452970
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
10.3
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 16, 2015
Actual Primary Completion Date :
May 10, 2016
Actual Study Completion Date :
May 25, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) of patients with advanced or metastatic biliary cancer after retreatment with gemcitabine and cisplatin following treatment with RRx-001 [Up to 2 years]

    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

  1. Disease control rate (DCR) [Up to 2 years]

  2. Overall Survival [Up to 2 years]

  3. Number, frequency and type of adverse events [Up to 2 years]

    Toxicity of gemcitabine and cisplatin following treatment with RRx-001

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21287

Sponsors and Collaborators

  • EpicentRx, Inc.

Investigators

  • Principal Investigator: Ana De Jesus Acosta, MD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EpicentRx, Inc.
ClinicalTrials.gov Identifier:
NCT02452970
Other Study ID Numbers:
  • RRx001-27-01
First Posted:
May 25, 2015
Last Update Posted:
Nov 15, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Cholangiocarcinoma
Gemcitabine

Study Results

No Results Posted as of Nov 15, 2019