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New treatment option for Ovarian Cancer
Official title Autophagy Maintenance (AUTOMAIN)
ClinicalTrials.gov ID: NCT06971744
What this study is testing
What is Hydroxychloroquine?
Hydroxychloroquine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-institution, single-arm study with a safety lead-in to determine if previously established safe doses of autophagy drugs, hydroxychloroquine (HCQ) and nelfinavir mesylate (NFV) will benefit ovarian cancer patients in a maintenance setting. Patients will receive the two study drugs HCQ and NFV in combination with maintenance bevacizumab.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have platinum-sensitive first recurrent high-grade serous or high-grade predominantly serous ovarian cancer, fallopian tube cancer...
- All participants must agree to have previously undergone genetic testing with germline panel testing with at least BRCA 1/2 mutation status known...
- Participants must be enrolled within 3-8 weeks of the first day of the last cycle of platinum-based chemotherapy for their first cancer recurrence. -...
- Evidence of platinum-sensitive response to current platinum-based chemotherapy with a partial or complete response based on imaging or CA-125 trend
- Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hCG]) within 7 days...
You likely can't join if
- New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of...
- Underlying psychiatric disorder requiring hospitalization within the last two years.
- Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
- Platinum resistant or refractory disease
- Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.
- Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days before registration with the exception of the...
See the full eligibility criteria
Who can join
- Participants must have platinum-sensitive first recurrent high-grade serous or high-grade predominantly serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Patients must have had a 6-month...
- All participants must agree to have previously undergone genetic testing with germline panel testing with at least BRCA 1/2 mutation status known and/or somatic tumor next generation sequencing with homologous...
- Participants must be enrolled within 3-8 weeks of the first day of the last cycle of platinum-based chemotherapy for their first cancer recurrence. - Participants must have received at least 3-courses of bevacizumab...
- Evidence of platinum-sensitive response to current platinum-based chemotherapy with a partial or complete response based on imaging or CA-125 trend
- Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hCG]) within 7 days before receiving the first dose of study treatment.
- Voluntary, signed, and dated, Institutional Review Board (IRB) approved consent form per regulatory and institutional guidelines.
- 18 years of age or older.
- ECOG performance status of 0-2
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN) and AST / ALT ≤ 3 times ULN. people with Gilbert's syndrome may be included if the total bilirubin is \< 3 times ULN and the direct bilirubin is within normal limits.
- CrCl ≥35 mL/min, according to the Cockgroft-Gault formula.
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3.
- Platelet count ≥ 75,000 cells / mm3
- Hemoglobin ≥ 9 g/ dL, recent transfusion is allowed, though must be ≥ 7 days C1D1 of investigational agents
- Adequately controlled blood pressure (\<160 mm Hg/100 mm Hg) as determined by the treating investigator.
- people with the potential to produce children must agree to effective contraceptive method use during study participation and at least 6 months after discontinuation of the study.
- Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks before study entry.
- Patients must discontinue any statin use within 48 hours of beginning study treatment.
- Patients must have a QT interval of \<450 ms on screening upon ECG.
- Patients who have diabetes mellitus must have it well-controlled (A1c of \<8%).
What rules you out
- New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on baseline ECG.
- Underlying psychiatric disorder requiring hospitalization within the last two years.
- Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
- Platinum resistant or refractory disease
- Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.
- Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days before registration with the exception of the platinum doublet and bevacizumab.
- Unwillingness or inability to comply with procedures required in this protocol.
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
- Patients who are receiving coumadin
- Patients who are currently participating in any other clinical trial of an investigational product.
- Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
- Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled in this study.
- Female patients who are of child-bearing potential (WOCBP) who are pregnant or planning to become pregnant during the study or within 6 months of the last dose of study drugs. A urine pregnancy test for WOCBP will be...
- Patients unable to stop taking strong inhibitors and inducers of CYP2C8, CYP3A4, CYP2C19, CYP2D6, FMO-1, and MAO-A.
- Patients unable to stop taking substrates of CYP2D6, CYP3A4, P-gp, MATE1K, and MATE2K.
- Patients diagnosed with myasthenia gravis
- Patients with G6PD Deficiency
- Patients with porphyria
- Platinum-sensitive patients that are candidates for PARP inhibitor maintenance, patients will be allowed if previously did not tolerate PARP and opt against PARP maintenance
- Patients that have contraindications to bevacizumab, as per approved product labeling
- Patients that have a high ASCVD score based on the American College of Cardiology ASCVD Risk Estimator Plus calculator and who should not stop their statin due to cardiovascular risk
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.