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

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ClinicalTrials.gov Identifier: NCT02096354
Recruitment Status : Active, not recruiting
First Posted : March 26, 2014
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
EpicentRx, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: RRx-001 Drug: Regorafenib Drug: Irinotecan Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
Study Start Date : May 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: RRx-001
Drug: Irinotecan
To be dosed after RRx-001 or regorafenib
Other Name: 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)
Drug: Regorafenib
Other Name: Stivarga

Drug: Irinotecan
To be dosed after RRx-001 or regorafenib
Other Name: With or without bevacizumab




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 10 months ]
    To assess and compare the safety and tolerability in the RRx-001 vs regorafenib treatment arms.

  2. Objective Response Rate [ Time Frame: 10 months ]
    To assess and compare objective response rate (ORR) in the RRx-001 vs regorafenib treatment arms.

  3. Clinical Benefit Rate [ Time Frame: 4 months ]
    To assess and compare the clinical benefit rate (CBR = Complete Response + Partial response + SD≥4 months) in the RRx-001 vs regorafenib treatment arms.

  4. Progression Free Survival [ Time Frame: 10 months ]
    To assess and compare the progression free survival (PFS) in the RRx-001 vs regorafenib treatment arms.

  5. Duration of Response [ Time Frame: 10 months ]
    To assess and compare the duration of response (DOR) in the RRx-001 vs regorafenib treatment arms.

  6. Duration of Clinical Benefit [ Time Frame: 10 months ]
    To assess and compare the duration of clinical benefit (DCB) in the RRx- 001 vs regorafenib treatment arms.

  7. Time to Progression [ Time Frame: 10 months ]
    To assess and compare the time to progression (TTP) in the RRx-001 vs regorafenib treatment arms.

  8. Response to subsequent therapies [ Time Frame: 12 months ]
    To assess and compare the response and clinical benefit to subsequent therapies in the RRx-001 vs regorafenib treatment arms.

  9. Quality of life (QOL) by QOL questionnaire [ Time Frame: 10 month ]
    To assess and compare the quality of life (QOL) in the RRx-001 vs regorafenib treatment arms using the a QOL questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096354


Locations
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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Stanford University
Stanford, California, United States, 94305
United States, Hawaii
Kaiser Permanete
Honolulu, Hawaii, United States, 96819
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Aquilino Cancer Center, Maryland Oncology and Hematology PA
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
EpicentRx, Inc.
Investigators
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Study Director: Bryan Oronsky, MD EpicentRx, Inc.

Additional Information:
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Responsible Party: EpicentRx, Inc.
ClinicalTrials.gov Identifier: NCT02096354     History of Changes
Other Study ID Numbers: RRx001-21-02
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action