Actively Recruiting
COAST Therapy in Advanced Solid Tumors and Prostate Cancer
Led by Medical University of South Carolina · Updated on 2026-05-13
76
Participants Needed
1
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 orally.
CONDITIONS
Official Title
COAST Therapy in Advanced Solid Tumors and Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II) with PSA of at least 0.1 ng/mL
- Tissue diagnosis documented by pathology report or clinic note
- Measurable or evaluable tumor by RECIST, blood biomarker, or radionuclide imaging
- Signed informed consent form as per regulatory guidelines
- Documented disease progression after treatment with one or more standard systemic regimens
- 18 years of age or older
- ECOG performance status of 0 to 2
- Bilirubin less than or equal to 1.5 times upper limit of normal (ULN); subjects with Gilbert's syndrome may be included under specific bilirubin limits
- Serum creatinine less than or equal to 1.5 times ULN
- Absolute neutrophil count at least 1,000 cells/mm3
- Platelet count at least 75,000 cells/mm3
- Hemoglobin at least 9 g/dL
- Fasting glucose less than or equal to 160 mg/dL or non-fasting glucose less than or equal to 200 mg/dL
- Urinalysis with no clinically significant abnormalities
- Adequately controlled blood pressure
- Effective contraceptive use during study participation if able to produce children
- Stable narcotic analgesic doses for at least 2 weeks prior to study entry
- Patients starting nelfinavir must discontinue statin use within 48 hours before treatment
You will not qualify if you...
- New York Heart Association Class III or IV heart disease, recent myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG
- Psychiatric disorder requiring hospitalization in the last 2 years
- Significant neurological disorders like Parkinson's disease, dementia, or multiple sclerosis
- Active uncontrolled infections requiring systemic therapy
- Radiation therapy, surgery, or investigational therapy within 28 days prior to registration
- Inability or unwillingness to comply with study procedures
- Serious noncancer disease that could affect study objectives
- Current use of blood thinners such as coumadin, apixaban, argatroban, or rivaroxaban
- Participation in another investigational clinical trial
- Mental incapacitation or psychiatric illness preventing study participation
- Prisoners or involuntarily detained patients for psychiatric or physical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
HCC Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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