Autophagy Maintenance (AUTOMAIN)

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06971744
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydroxychloroquine — DRUG
    3 x 200 milligram tablets twice daily
  • Nelfinavir — DRUG
    2x 625 milligram tablets twice daily
  • Bevacizumab — DRUG
    IV 15 milligram/kilogram every 3 weeks

Study Details

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.

Key Dates

Start date
Dec 18, 2025
Status verified
Dec 2025
Primary completion
Jun 18, 2028
Completion
Jun 18, 2029

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hydroxychloroquine+Nelfinavir+Bevacizumab
    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)

Primary Outcome Measure

Safety of combination of study drugs [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Casey Charlton

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