MedTrace Logo

RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)

NCT02801097 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-05-17

No results posted yet for this study

Summary

This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan.

RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.

Conditions

Interventions

DRUG

RRx-001

DRUG

Irinotecan

Sponsors & Collaborators

  • EpicentRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Bryan Oronsky, MD · EpicentRx, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-30
Primary Completion
2018-11-22
Completion
2019-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801097 on ClinicalTrials.gov