REGN7508 for Cancer-Related Blood Clots
(ROXI-CAT-I Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, REGN7508, to determine its ability to prevent blood clots in people with solid tumors undergoing cancer treatment. It compares the drug to a placebo (a harmless pill with no active medicine) to assess its effectiveness. The study also examines side effects, the drug's movement in the body, and whether the body produces antibodies against it. People diagnosed with advanced cancer and at higher risk for blood clots might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that REGN7508 is likely to be safe for humans?
Research has shown that REGN7508 is generally safe for patients. In earlier studies, no treatment-related deaths occurred among those taking REGN7508. This suggests the treatment is reasonably safe for preventing blood clots, even in people with cancer or those undergoing surgery. While side effects can occur with any medication, these findings provide reassurance about the safety of REGN7508.12345
Why do researchers think this study treatment might be promising for cancer-related blood clots?
Unlike the standard treatments for cancer-related blood clots, which typically involve anticoagulants like warfarin or direct oral anticoagulants (DOACs), REGN7508 offers a novel approach. This experimental drug is designed to specifically target and address the blood clotting process associated with cancer, potentially offering a more focused treatment. Researchers are excited because REGN7508 may provide better outcomes with fewer side effects, addressing a significant need for safer, more effective options in managing blood clots linked to cancer.
What evidence suggests that REGN7508 might be an effective treatment for cancer-related blood clots?
Research has shown that REGN7508 effectively prevents blood clots in people with cancer. In one study, only 7% of participants taking REGN7508 developed blood clots, compared to 21% for those on enoxaparin and 12% for those on apixaban. This indicates that REGN7508 is more effective at preventing blood clots than these other treatments. In this trial, participants will receive either REGN7508 or a placebo to further evaluate its effectiveness and safety. The drug has successfully prevented a specific type of blood clot called venous thromboembolism. Researchers aim to determine whether it can reduce the risk of blood clots without increasing side effects. Early results suggest it could be a promising option for people with cancer who are at risk for blood clots.12467
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with advanced or spreading solid tumors who are at higher risk of blood clots, either due to their cancer type/genetics or a high Khorana score. Participants must be starting or already on cancer treatment, or recently had surgery, and need to be well enough for daily activities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive REGN7508 or placebo to prevent Cancer-Associated Thrombosis while undergoing anticancer treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- REGN7508
Trial Overview
The study compares an experimental drug called REGN7508 to a placebo (inactive substance) to see if it can prevent dangerous blood clots in people with cancer. Participants are randomly assigned to receive either the study drug or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
Efficacy and safety of REGN9933A2 and REGN7508Cat for ...
Interpretation: REGN7508Cat was superior to enoxaparin for venous thromboembolism prevention; REGN9933A2 was not superior to enoxaparin. The ...
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/REGN/pressreleases/225477/regeneron-advances-regn7508-into-phase-3-to-tackle-cancer-linked-blood-clots/Regeneron Advances REGN7508 Into Phase 3 To Tackle ...
The study aims to show that REGN7508 can cut the risk of blood clots versus placebo, while keeping safety in line with current standards. The ...
3.
clinicaltrials.eu
clinicaltrials.eu/trial/a-study-to-evaluate-the-effectiveness-of-regn7508-for-preventing-blood-clots-in-adults-with-solid-tumors-undergoing-cancer-treatment/A study to evaluate the effectiveness of REGN7508 ...
A study to evaluate the effectiveness of REGN7508 for preventing blood clots in adults with solid tumors undergoing cancer treatment.
4.
newsroom.regeneron.com
newsroom.regeneron.com/news-releases/news-release-details/phase-2-trials-demonstrating-antithrombotic-effect-two-novel/Phase 2 Trials Demonstrating Antithrombotic Effect of Two ...
As published and presented, the results showed that both REGN7508Cat and REGN9933A2 demonstrated clear efficacy for VTE prevention following ...
NCT07493304 | Treatment and Secondary Prevention of ...
The aim of the study is to see how safe and effective the study drug is at treating and preventing further blood clots in participants with or without cancer ( ...
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo ...
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on the prevention of Cancer-
REGN7508 / Regeneron
ROXI-CAT-I: REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis (clinicaltrials.gov) - P3 | N=860 | Recruiting | Sponsor: ...
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