A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
EpicentRx, Inc.
Study ID
NCT02096354
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RRx-001 — DRUG
  • Regorafenib — DRUG
  • Irinotecan — DRUG
    To be dosed after RRx-001 or regorafenib

Study Details

This two-stage study is designed to compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies in a parallel comparative study. Patients who are suffering from advanced or metastatic (meaning the disease has spread) colorectal cancer are invited to participate in this study. There will be two groups of patients (Randomized, open label study), one of these will receive RRx-001 and the other one will receive regorafenib. If patients qualify to participate in this study, they will be randomly assigned to the 'interventional arm' where patients will receive the experimental drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care, Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance (1 out of 3) of receiving regorafenib. On progression in the first part of the study, provided ECOG performance status is adequate, and if clinically appropriate i.e. there are no absolute or relative contraindications in the opinion of the Investigator, all subjects will enter the second part of the study and receive irinotecan plus bevacizumab. Whether patients are given RRx-001 or regorafenib, they will also receive best supportive care, which includes treatments to help manage side effects and symptoms of cancer. This is an open label study, which means patients will know to which of these treatments, RRx-001 or regorafenib, they are assigned.

Key Dates

Start date
May 31, 2014
Status verified
Sep 2024
Primary completion
Apr 13, 2018
Completion
Oct 8, 2020

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RRx-001 followed by irinotecan
    Once-weekly intravenous RRx-001 at a dose of 4 mg on Days 1, 8, 15, and 22 of a 4-week cycle. On progression and if eligible, patients will receive irinotecan (with or without bevacizumab)
  • Active Comparator: Regorafenib followed by irinotecan
    Regorafenib daily on Days 1- 21 of a 4-week cycle. On progression and if eligible, patients will receive irinotecan (with or without bevacizumab)

Primary Outcome Measure

Overall Survival [ Time Frame: From date of enrollment until death or censorship. ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCSD Moores Cancer CenterLa JollaCalifornia92093-
Stanford UniversityStanfordCalifornia94305-
Kaiser PermaneteHonoluluHawaii96819-
Walter Reed National Military Medical CenterBethesdaMaryland20889-
Aquilino Cancer Center, Maryland Oncology and Hematology PARockvilleMaryland20850-

Find similar trials in La Jolla, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
UCSD Moores Cancer Center· La Jolla, CAStanford University· Stanford, CAKaiser Permanete· Honolulu, HIWalter Reed National Military Medical Center· Bethesda, MDAquilino Cancer Center, Maryland Oncology and Hematology PA· Rockville, MD

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