Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

EpicentRx, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: RRx-001
  • Drug: Regorafenib
  • Drug: Irinotecan

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Histological or cytological documentation of adenocarcinoma of the colon or rectum;

   - Subject must have received at least oxaliplatin-, and irinotecan-based regimens with
   bevacizumab and with, cetuximab or panitumumab if KRAS wildtype and are refractory to
   irinotecan;

   - Subject has measurable disease by radiographic techniques (computerized tomography
   [CT] or magnetic resonance imaging [MRI]);

   - Subjects with a history of brain metastasis are eligible for the study as long as they
   meet all the following criteria: their brain metastases have been treated, they have
   no evidence of progression or hemorrhage after treatment, have been off dexamethasone
   for 4 weeks prior to first study drug administration, and have no ongoing requirement
   for dexamethasone or anti-epileptic drugs;

   - Life expectancy of at least 12 weeks

   - Subject's Eastern Cooperative Group (ECOG) performance status is 0 or 1;

   - Adequate organ function

   - Fertile subjects must use effective contraception during the course of the study and
   for 30 days following withdrawal from the study;

Exclusion Criteria:

   - Clinically significant cardiovascular disease;

   - Unresolved toxicity higher attributed to any prior therapy/procedure excluding
   alopecia, hypothyroidism and oxaliplatin- induced neurotoxicity ≤ Grade 2 for at least
   14 days;

   - Evidence or history of tendency or predisposition to active bleeding. Any hemorrhage
   or bleeding event of Grade 3 or higher within 4 weeks of start of study medication;

   - Symptoms or signs of active brain metastases;

   - History of an allergic reaction or intolerance to irinotecan

   - Hepatic encephalopathy

   - Cholangitis that required treatment or intervention within 4 weeks of study enrollment

   - Concurrent anticancer therapy or any cytotoxic therapy within 1 month prior to Day 1.
   Corticosteroid therapy is not allowed except on dosing days;

   - Subject has previously received regorafenib;

   - Clear contraindication for systemic corticosteroids (diabetes mellitus is not per se a
   clear contraindication);

   - Severe hypoalbuminemia (albumin < 3.0 g/dL);

   - Subjects who are pregnant or lactating or who are planning to become pregnant during
   the course of the study are excluded.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting