Cancer Treatments Access Extension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to provide ongoing access to cancer treatments for individuals benefiting from a specific Exelixis-sponsored study. The study includes treatments such as Cabozantinib and Zanzalintinib, either alone or combined with other medications. It targets those who continue to see positive results from their current study treatment and cannot access it locally. Participants should be able to continue with the treatment plan and must not have been disqualified from their initial study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of these treatments to a wider population.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cabozantinib is generally safe to manage. Common side effects include diarrhea and tiredness, affecting more than 25% of patients. Some patients may also experience low calcium levels, though severe cases are rare. Cabozantinib can cause heart problems, so regular check-ups are important.
Early findings suggest that zanzalintinib has a safety profile similar to other treatments targeting multiple pathways in cancer cells. Experts closely monitor its safety to protect participants. However, its safety and effectiveness are not fully confirmed yet.
Both treatments carry some risks, but researchers carefully monitor them to ensure participant safety.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for cancer, which often involve chemotherapy or radiation, Cabozantinib and Zanzalintinib offer a fresh approach by targeting specific proteins that help tumors grow and spread. Cabozantinib works by inhibiting the activity of tyrosine kinases, which are enzymes involved in tumor growth and blood vessel development. Zanzalintinib, on the other hand, is designed to block the VEGFR, a receptor that plays a crucial role in the formation of blood vessels that supply the tumor. Researchers are excited about these treatments because they might not only be more effective but also potentially have fewer side effects compared to traditional cancer therapies.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that cabozantinib, one of the treatments in this trial, holds promise for cancer treatment. Specifically, studies found that after 12 months, 85.7% of patients treated with cabozantinib remained alive, compared to 75.6% with other treatments. More than 40% of patients experienced tumor shrinkage. Additionally, cabozantinib was associated with a 34% decrease in the rate of disease progression or death. These findings suggest that cabozantinib can be an effective option for treating cancer. Participants in this trial may receive cabozantinib alone or in combination with other agents, depending on their study treatment group.678910
Who Is on the Research Team?
Medical Director
Principal Investigator
Exelixis
Are You a Good Fit for This Trial?
This trial is for people with certain cancers (like kidney, liver, prostate, thyroid, and colorectal) who were already in an Exelixis-sponsored study and are still benefiting from the treatment. Participants must be able to follow the new study rules and start treatment again within a set time.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Long-term Extension
Participants continue to receive study treatment if they are deriving clinical benefit and do not have access to treatment locally
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone
- Atezolizumab
- Cabozantinib
- Enzalutamide
- Nivolumab
- Prednisone
- Zanzalintinib
Trial Overview
The study lets eligible participants keep getting their previous cancer treatments—such as Cabozantinib, Zanzalintinib, Abiraterone, Nivolumab, Prednisone, Enzalutamide or Atezolizumab—if they can't get them locally. It’s an extension of earlier studies.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Exelixis
Lead Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
Real-World Results of Cabozantinib Given as Alternative ...
(85.7% vs. 75.6% survival rate after 12 months) and objective response rate. More than 40% of all patients had a response in terms of tumor shrinkage (PR+CR) ...
2.
ir.exelixis.com
ir.exelixis.com/news-releases/news-release-details/exelixis-announces-phase-1-trial-results-cabozantinibExelixis Announces Phase 1 Trial Results for Cabozantinib in ...
The objective response rate was 43 percent … the five-year survival rate is only 12 percent, with no identified cure for the disease.4
Cabozantinib Efficacious After Treatment with First-Line ...
On average, patients received cabozantinib for 4.7 months. The objective response rate was 27.2% (all partial responses). An additional 22.7% of patients ...
Real-world outcomes of nivolumab and cabozantinib in ... - PMC
The final results of the meteor trial demonstrated, for the cabozantinib and everolimus groups, an overall survival (os) of 21.4 months and 16.5 ...
Press Release
CABOMETYX significantly reduced the risk of disease progression or death by 74% and 60% in patients with non-functional and functional advanced ...
4197474 This label may not be the latest approved by FDA ...
The most commonly reported (≥ 25%) adverse reactions are: diarrhea, fatigue or altered mental function. CABOMETYX can cause fetal harm when administered to a ...
This label may not be the latest approved by FDA. For current ...
CABOMETYX can cause hypocalcemia. hypocalcemia occurred in 13% of patients treated with CABOMETYX, including Grade 3 in 2% and Grade 4 in 1% of patients.
Cabozantinib (oral route) - Side effects & dosage
Safety and efficacy have not been established. This medicine may cause heart failure, which may lead to death. Check with your doctor right ...
View of Cabozantinib (Cabometyx)
The safety profile in the population assessed was considered manageable and consistent with the known safety profile of cabozantinib. Introduction. Disease ...
Label: Cabometyx — Cabozantinib Tablet - DailyMed - NIH
Based on data from animal studies and its mechanism of action, CABOMETYX can cause fetal harm when administered to a pregnant woman. Cabozantinib administration ...
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