COAST Therapy in Advanced Solid Tumors and Prostate Cancer

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Aug 30, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "COAST Therapy in Advanced Solid Tumors and Prostate Cancer," is investigating the safety and effectiveness of a combination of five oral medications for treating advanced solid tumors, including prostate cancer. The study aims to see how well these drugs work together and if they are safe for patients. To participate, individuals must be at least 18 years old and have advanced cancer that has not responded to standard treatments. Specifically, prostate cancer patients need to have a certain level of a specific blood marker known as PSA.

Participants in this study will take the medications at home and will be closely monitored by healthcare professionals to check for any side effects and to see how well the treatment is working. It’s important to know that certain health conditions may prevent someone from participating, such as serious heart issues or uncontrolled infections. This trial is currently recruiting participants, and it’s a chance for patients to access potentially new treatment options while contributing to important research on cancer therapies.

Gender

ALL

Eligibility criteria

• 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.