COAST Therapy for Prostate Cancer
(COAST Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that patients stop using statins (cholesterol-lowering drugs) within 48 hours before starting the study treatment if they are taking nelfinavir mesylate. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.
What data supports the effectiveness of the COAST Therapy drugs for prostate cancer?
Is Metformin safe for use in humans?
What makes the COAST Therapy drug unique for prostate cancer?
The COAST Therapy drug is unique because it combines multiple agents like Hydroxychloroquine, Metformin, Sirolimus, Dasatinib, and Nelfinavir, which are not typically used together for prostate cancer. This combination targets different pathways in cancer cells, potentially offering a novel approach compared to standard treatments like docetaxel-based therapies.89101112
Eligibility Criteria
Adults with advanced solid tumors or prostate cancer, who have tried standard treatments without success. They must be relatively healthy, with stable vital signs and organ function, not on certain blood thinners or statins, and willing to use contraception if they can have children.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase I
Phase I cohort receives increasing components of the COAST regimen following a traditional 3+3 escalation design to determine the maximum tolerated dose.
Treatment Phase II
Phase II evaluates the anti-tumor activity of the COAST RP2D combination in patients with advanced prostate cancer.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of PSA progression-free rate.
Treatment Details
Interventions
- Hydroxychloroquine, Metformin, Sirolimus
- Hydroxychloroquine, Metformin, Sirolimus, Dasatanib
- Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir
- Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor