💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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