5-Drug cocktail takes on tough cancers in new trial
NCT ID NCT05036226
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a mix of five oral drugs (hydroxychloroquine, metformin, sirolimus, dasatinib, and nelfinavir) in people with advanced solid tumors or prostate cancer that has come back. The goal is to find the safest dose and see if the combination can stop the cancer from growing. About 76 adults will take part in this early-phase trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 standard systemic regimens. Single or multiple regimens of chemotherapy, hormone suppression therapy, radiation therapy, surgery, immunotherapy, or adoptive cell therapy are allowed. 6. 18 years of age or older. 7. ECOG performance status of 0-2. 8. 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. 9. Serum creatinine ≤ 1.5 times ULN. 10. Absolute neutrophil count (ANC) ≥ 1,000 cells / mm3 11. Platelet count ≥ 75,000 cells / mm3 12. Hemoglobin ≥ 9 g/ dL. 13. Fasting glucose ≤ 160 mg/dL or non-fasting glucose ≤ 200 mg/dL. 14. Urinalysis with no clinically significant abnormalities. 15. Adequately controlled blood pressure as determined by the treating investigator. 16. Subjects with the potential to produce children must agree to effective contraceptive method use during study participation. 17. Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry. 18. Patients being considered for a dose level containing nelfinavir mesylate must discontinue any statin use within 48 hours of beginning study treatment. Exclusion Criteria: 1. 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. 2. Underlying psychiatric disorder requiring hospitalization within the last two years. 3. Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator. 4. Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy. 5. Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days prior to registration. 6. Unwillingness or inability to comply with procedures required in this protocol. 7. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator. 8. Patients who are receiving, coumadin, apixaban, argatroban or rivaroxaban. 9. Patients who are currently participating in any other clinical trial of an investigational product. 10. Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator. 11. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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