COAST Therapy in Advanced Solid Tumors and Prostate Cancer

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05036226
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Prostate Cancer Recurrent
  • Solid Tumor, Adult

Eligibility Criteria

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

Interventions

  • Hydroxychloroquine, Metformin, Sirolimus — COMBINATION_PRODUCT
    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily
  • Hydroxychloroquine, Metformin, Sirolimus, Dasatanib — COMBINATION_PRODUCT
    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Dasatinib 20mg daily
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir — COMBINATION_PRODUCT
    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib — COMBINATION_PRODUCT
    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily Dasatanib 20mg daily
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir — COMBINATION_PRODUCT
    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib — COMBINATION_PRODUCT
    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily Dasatanib 20mg daily

Study Details

The purpose of this Phase I/II study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of solid tumor cancers. The drugs are hydroxychloroquine, metformin, sirolimus, dasatinib and nelfinavir and are given orally.

Key Dates

Start date
Mar 3, 2022
Status verified
May 2026
Primary completion
May 21, 2027
Completion
May 21, 2028

Study Design

Enrollment
76 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level 1
  • Experimental: Dose level 2a
  • Experimental: Dose level 2b
  • Experimental: Dose level 3a
  • Experimental: Dose level 3b
  • Experimental: Dose level 4

Primary Outcome Measure

Maximum Tolerated Dose (MTD) - Phase I [ Time Frame: Minimum of 3 months after start of treatment on each dose level ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321
Brian Orr, MD (PRINCIPAL_INVESTIGATOR)
Joseph Delaney, PhD (SUB_INVESTIGATOR)
Michael B Lilly, MD (SUB_INVESTIGATOR)

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Medical University of South Carolina· Charleston, SC

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