RecruitingPhase 1Phase 2NCT05036226

COAST Therapy in Advanced Solid Tumors and Prostate Cancer

Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I/II Trial


Sponsor

Medical University of South Carolina

Enrollment

76 participants

Start Date

Mar 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination therapy called COAST — using existing drugs including nelfinavir — in people with advanced solid tumors (Phase I) or advanced prostate cancer (Phase II) whose cancer has continued to grow despite prior treatments. **You may be eligible if...** - You are 18 or older with advanced solid tumor cancer or advanced prostate cancer - Your cancer has progressed on at least one prior treatment - You are reasonably functional (ECOG status 0–2) - Your blood counts, kidney, and liver function meet minimum thresholds - Your blood sugar is reasonably controlled **You may NOT be eligible if...** - You have significant heart disease (heart failure, recent heart attack, unstable heart rhythm) - You have had radiotherapy, surgery, or another experimental treatment within 28 days - You have active, uncontrolled infections - You are taking blood-thinning drugs like warfarin, apixaban, or rivaroxaban - You have a serious psychiatric condition - You are currently in another clinical trial - You are a prisoner or under compulsory detention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTHydroxychloroquine, Metformin, Sirolimus

Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily

COMBINATION_PRODUCTHydroxychloroquine, Metformin, Sirolimus, Dasatanib

Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Dasatinib 20mg daily

COMBINATION_PRODUCTHydroxychloroquine, Metformin, Sirolimus, Nelfinavir

Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily

COMBINATION_PRODUCTHydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib

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

COMBINATION_PRODUCTHydroxychloroquine, Metformin, Sirolimus, Nelfinavir

Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily

COMBINATION_PRODUCTHydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib

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


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT05036226


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