NCT05036226 · Medical University of South Carolina
COAST Therapy in Advanced Solid Tumors and Prostate Cancer
(COAST)
What this study is about
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 taken by mouth.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Tissue diagnosis documented by pathology report, or clinic note attesting to same.
- Measurable / evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging
- Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.
- Documented progression of disease during treatment with one or more standard systemic regimens. Single or multiple regimens of chemotherapy, hormone suppression therapy, radiation therapy, surgery, immunotherapy, or adoptive cell therapy are allowed.
- 18 years of age or older.
- ECOG performance status of 0-2.
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) and AST / ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \< 3 times ULN and the direct bilirubin is within normal limits.
- Serum creatinine ≤ 1.5 times ULN.
- Absolute neutrophil count (ANC) ≥ 1,000 cells / mm3
- Platelet count ≥ 75,000 cells / mm3
- Hemoglobin ≥ 9 g/ dL.
- Fasting glucose ≤ 160 mg/dL or non-fasting glucose ≤ 200 mg/dL.
- Urinalysis with no clinically significant abnormalities.
- Adequately controlled blood pressure as determined by the treating investigator.
- Subjects with the potential to produce children must agree to effective contraceptive method use during study participation.
- Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.
- Patients being considered for a dose level containing nelfinavir mesylate must discontinue any statin use within 48 hours of beginning study treatment.
Exclusion criteria
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on ECG.
- Underlying psychiatric disorder requiring hospitalization within the last two years.
- Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
- Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.
- Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days prior to registration.
- Unwillingness or inability to comply with procedures required in this protocol.
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
- Patients who are receiving, coumadin, apixaban, argatroban or rivaroxaban.
- Patients who are currently participating in any other clinical trial of an investigational product.
- Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
- Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Where
- Charleston, South Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2026 · Source of record for eligibility and locations