Medical University of South Carolina
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.
This is a Phase I/II safety and efficacy study of COAST therapy in patients with advanced cancer for which no satisfactory therapy options exist. An initial Phase I cohort of 18-30 patients with advanced cancer will receive increasing components of the COAST regimen following a traditional 3+3 escalation design. The starting COAST combination includes hydroxychloroquine, sirolimus and metformin (DL1 - base combination). If this three-drug base combination is cleared for safety, two dose levels will be opened for enrollment exploring the safety of the base in combination with either dasatinib o…
Inclusion Criteria: 1. Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II). Prostate cancer patients must have a PSA of at least 0.1 ng/mL. 2. Tissue diagnosis documented by pathology report, or clinic note attesting to same. 3. Measurable / evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging 4. Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines. 5. Documented progression of disease during treatment with one or more sta…
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Dasatinib 20mg daily
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily
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 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily
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
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