Hydroxychloroquine + Nelfinavir + Bevacizumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of three drugs to determine if they can prevent the recurrence of certain types of ovarian cancer after initial treatment. The study combines hydroxychloroquine and nelfinavir, which affect cell processes, with bevacizumab, a drug used to maintain cancer treatment. It targets patients whose cancer responded well to platinum-based chemotherapy and who are already using bevacizumab. Participants should have ovarian, fallopian tube, or peritoneal cancer that responded well to previous treatments and have genetic test results available. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in ovarian cancer care.
Will I have to stop taking my current medications?
You will need to stop taking any statins 48 hours before starting the study treatment. Additionally, if you are taking certain medications that affect specific liver enzymes (like CYP2C8, CYP3A4, and others), you may need to stop those as well. Please discuss your current medications with the study team to determine if any changes are necessary.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining hydroxychloroquine and nelfinavir with bevacizumab affects ovarian cancer. Hydroxychloroquine and nelfinavir can help kill cancer cells and may enhance the effectiveness of other treatments. Bevacizumab has delayed the progression of ovarian cancer in studies.
Regarding safety, previous patients have generally tolerated this combination well. However, like any treatment, side effects may occur. For example, bevacizumab can sometimes affect wound healing. Early studies tested this combination to ensure its safety for patients. The study's later phase suggests that earlier trials found the treatment safe for humans. Always consult a medical professional about potential risks and benefits before joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination treatment of Hydroxychloroquine, Nelfinavir, and Bevacizumab for ovarian cancer because it offers a novel approach by targeting multiple pathways simultaneously. Bevacizumab is an antibody that inhibits the growth of blood vessels that supply tumors, while Hydroxychloroquine and Nelfinavir are believed to disrupt the cancer cells’ survival mechanisms. This multi-pronged attack could potentially enhance effectiveness against ovarian cancer, offering hope for improved outcomes compared to the standard treatments like chemotherapy and targeted therapies alone.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research shows that bevacizumab, when combined with chemotherapy, can help treat ovarian cancer. Several studies have found that it slows the disease and improves patient outcomes. In this trial, participants will receive a combination of Hydroxychloroquine (HCQ), Nelfinavir, and Bevacizumab. Researchers are studying HCQ and Nelfinavir for their ability to block autophagy, a process cancer cells use to survive. Animal studies suggest that these drugs, when used with other treatments, can help stop ovarian cancer from growing. While more research is needed, combining HCQ and Nelfinavir with Bevacizumab appears promising for enhancing treatment effects in ovarian cancer patients.12356
Are You a Good Fit for This Trial?
This trial is for those with first recurrent high-grade serous ovarian cancer or related cancers, who responded well to platinum chemotherapy and agree to continue maintenance bevacizumab therapy. Participants must have completed genetic testing, have certain kidney function levels (CrCl ≥35 mL/min), and enroll within a specific timeframe after their last chemo cycle. Pregnant women or those with poor performance status are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
Safety lead-in to determine if previously established safe doses of autophagy drugs will benefit patients
Treatment
Participants receive Hydroxychloroquine, Nelfinavir, and Bevacizumab in combination
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Hydroxychloroquine
- Nelfinavir
Trial Overview
The AUTOMAIN study tests whether hydroxychloroquine and nelfinavir can benefit ovarian cancer patients when taken alongside maintenance bevacizumab. It's a single-arm trial at one institution focusing on safety and the effectiveness of these autophagy drugs in a maintenance setting post-chemotherapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects will take Hydroxychloroquine 3x 200 milligram tablets twice daily Subjects will take Nelfinavir 2x 625 milligram tablets twice daily Subjects will be administered Bevacizumab IV 15 milligram/kilogram every 3 weeks. DLT Period 21 Days (1 Cycle)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Citations
NCT06971744 | Autophagy Maintenance (AUTOMAIN)
Evaluate the anti-tumor activity of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer.
Combination of Autophagy Selective Therapeutics With Doxil
In vivo studies of ovarian cancer have revealed that chloroquine can be combined with up to four other autophagy drugs to suppress ovarian ...
Real-world outcomes associated with bevacizumab ...
Real-world outcomes with bevacizumab in PL-R OC are inferior to those in the pivotal clinical trial. Survival has not significantly improved ...
Effect of bevacizumab in combination with chemotherapy ...
A total of 7 trials have shown that the use of bevacizumab in the treatment of ovarian cancer patients has reduced wound healing.
Drug repurposing in gynaecological cancers
This section highlights examples of repurposed drugs, their mechanisms of action, and their potential to improve outcomes in gynaecological cancer treatment.
Bevacizumab Significantly Improves Progression-Free ...
Progression-free survival (PFS) in patients with epithelial ovarian cancer (EOC) was significantly improved by adding bevacizumab to the ...
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