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 :
Completed
First Posted : March 26, 2014
Last Update Posted : May 16, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | March 20, 2014 | |||
First Posted Date ICMJE | March 26, 2014 | |||
Last Update Posted Date | May 16, 2022 | |||
Study Start Date ICMJE | May 2014 | |||
Actual Primary Completion Date | April 13, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: 10 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer | |||
Official Title ICMJE | A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer | |||
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. |
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Detailed Description | Purpose 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. Qualifying patients will be randomly assigned (like the flip of a coin) to the 'interventional arm' and receive the experimental drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care, Regorafenib. Patients will 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 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. Background Oxygen is vital to life, we need it to breathe, for example, but at the same time it gives rise to byproducts that are toxic called free radicals. Free radicals are defined as "oxidants". Similarly, substances that interact with and neutralize free radicals, thus preventing them from causing damage, are called "antioxidants". Examples of recognizable antioxidants are Vitamin E, Vitamin C and beta-carotene. Antioxidants are also known as "free radical scavengers." When free radicals are present in excess of antioxidants damage may occur. A free radical is an unstable molecule with an unpaired electron, an electrically charged particle, which seeks out another electron to return to a state of balance. An example of a free radical is hydrogen peroxide, recognizable as the household product that "bubbles" when it's poured on wounds. These bubbles come from oxygen free radicals, which are toxic to bacteria and all living cells, including cancer. The fact that these free radicals are toxic has to do with how reactive they are-imagine free radicals as high-speed ball bearings that smash into other molecules in order to "steal" back an electron and end their radical state, which sets off a chain reaction that transforms once stable compounds into a string of reactive radicals. As new free radicals are created in this chain reaction, they randomly slam into whatever molecules they are closest to and steal their electrons, corroding them, like a biological form of rust. This process is repeated over and over, picking up speed, until an antioxidant can "neutralize" the free radicals and put a stop to the snowball effect. In the same way that this free radical bombardment can damage not only bacteria but also healthy tissues in the body, it is also capable of destroying cancer cells. The current consensus is that compared to normal tissue tumor cells may accumulate elevated levels of free radicals, which contribute to the development of cancer. This is potentially a fatal weakness, a form of biological "Kryptonite", which can be used to advantage since the addition of even a small amount of free radicals may push the tumor over the edge, past the tipping point, above tolerable thresholds, breaking the camel's back. Similar to the expression "live by the sword, die by the sword", free radicals may lead to the development of cancer but they also are capable of harming it when present in excess. RRx-001 is a completely new type of drug that comes from the U.S. aerospace or rocket science industry. It is activated to deliver free radicals to tissues that have low levels of oxygen. Compared to normal tissues, which have higher levels of oxygen, most, if not all, tumors exist in a low-oxygen environment, perhaps to prevent oxidation. In this way the free radicals delivered by RRx-001 to cancer cells under low oxygen conditions are able, in theory, to cause their targeted destruction without harming normal cells. In general, colorectal tumors have low levels of antioxidants and, without this antioxidant protection, these tumors are more likely to be harmed by free radicals, so a treatment like RRx-001, which is able to increase the free radicals in the tumor, may benefit patients with colorectal cancer; this is a reason for studying RRx-001 in colorectal cancer. So far, in a Phase 1 study, 25 men and women with advanced, incurable cancer have received RRx-001 for different lengths of time and at doses that ranged from 10 mg/m2 to 83 mg/m2 once a week. Regorafenib is a drug approved by the FDA to treat colon cancer after previous chemotherapy is no longer effective. It belongs to a class of targeted drugs known as tyrosine kinase inhibitors. Tyrosine kinases, which play a key role in many cell functions including cell growth and division, are commonly mutated or changed in cancer cells, becoming super-active and producing cells that have uncontrolled growth, and, therefore, blocking them with drugs like regorafenib may keep the cancer cells from growing. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
57 | |||
Original Estimated Enrollment ICMJE |
200 | |||
Actual Study Completion Date ICMJE | April 13, 2018 | |||
Actual Primary Completion Date | April 13, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02096354 | |||
Other Study ID Numbers ICMJE | RRx001-21-02 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | EpicentRx, Inc. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | EpicentRx, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | EpicentRx, Inc. | |||
Verification Date | May 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |