Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06971744

Autophagy Maintenance (AUTOMAIN)

Led by Medical University of South Carolina · Updated on 2025-12-22

38

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Autophagy Maintenance (AUTOMAIN)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have platinum-sensitive first recurrent high-grade serous or high-grade predominantly serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with at least 6 months disease-free progression since last platinum chemotherapy.
  • Participants must have undergone genetic testing including germline panel testing with BRCA 1/2 mutation status and/or somatic tumor sequencing with HRD or LOH testing.
  • Participants must be enrolled within 3-8 weeks after the last cycle of platinum-based chemotherapy for their first recurrence.
  • Must have received at least 3 courses of bevacizumab during chemotherapy and plan to continue maintenance bevacizumab.
  • Evidence of platinum-sensitive response with partial or complete response by imaging or CA-125 trend.
  • Negative pregnancy test within 7 days before first study treatment for participants of childbearing potential.
  • Voluntary signed informed consent.
  • Age 18 years or older.
  • ECOG performance status of 0-2.
  • Bilirubin ≤1.5 times upper limit normal; AST/ALT ≤3 times upper limit normal; Gilbert's syndrome allowed with specific limits.
  • Creatinine clearance ≥35 mL/min.
  • Absolute neutrophil count ≥1,000 cells/mm3.
  • Platelet count ≥75,000 cells/mm3.
  • Hemoglobin ≥9 g/dL; recent transfusion allowed if ≥7 days before treatment.
  • Controlled blood pressure <160/100 mm Hg.
  • Agreement to effective contraception during and 6 months after study.
  • Stable narcotic analgesic dose for at least 2 weeks before enrollment.
  • Discontinuation of statins within 48 hours before study treatment.
  • QT interval <450 ms on ECG screening.
  • Well-controlled diabetes with A1c <8%.
Not Eligible

You will not qualify if you...

  • New York Heart Association Class III or IV heart disease, recent myocardial infarction within 6 months, unstable arrhythmia, or ischemia on baseline ECG.
  • Psychiatric hospitalization within the last 2 years.
  • Significant neurological disorders such as Parkinson's disease, dementia, or multiple sclerosis.
  • Platinum-resistant or refractory disease.
  • Active uncontrolled infections requiring systemic treatment.
  • Radiation, surgery, or investigational therapy within 28 days before registration except platinum doublet and bevacizumab.
  • Inability or unwillingness to comply with study procedures.
  • Serious nonmalignant diseases compromising study objectives.
  • Current use of coumadin.
  • Participation in another investigational clinical trial.
  • Mental incapacitation or psychiatric illness precluding participation.
  • Prisoners or involuntarily detained patients.
  • Pregnant or planning pregnancy during study or within 6 months after.
  • Unable to stop strong inhibitors or inducers of certain enzymes and transporters.
  • Diagnosed with myasthenia gravis, G6PD deficiency, or porphyria.
  • Candidates for PARP inhibitor maintenance unless intolerant and opting out.
  • Contraindications to bevacizumab.
  • High cardiovascular risk requiring continued statin use.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

B

Brian Orr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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