RECRUITING

COAST Therapy in Advanced Solid Tumors and Prostate Cancer

Conditions

Prostate Cancer Recurrent Solid Tumor, Adult

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I/II Trial

Quick Facts

Study Start:2022-03-03

Study Completion:2025-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05036226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Alan Brisendine

CONTACT

843-792-9007

brisend@musc.edu

Jasmin Brooks

CONTACT

brooksjm@musc.edu

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-03

Study Completion Date2025-10-15

Study Record Updates

Study Start Date2022-03-03

Study Completion Date2025-10-15

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer Recurrent
Solid Tumor, Adult