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New treatment option for Prostate Cancer Recurrent
Official title COAST Therapy in Advanced Solid Tumors and Prostate Cancer
ClinicalTrials.gov ID: NCT05036226
What this study is testing
What is Hydroxychloroquine, Metformin, Sirolimus?
Hydroxychloroquine, Metformin, Sirolimus is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer recurrent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of...
- 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.
See the full eligibility 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...
- 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. people 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.
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.