COAST Therapy in Advanced Solid Tumors and Prostate Cancer
COAST
Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I/II Trial
1 other identifier
interventional
76
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
March 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 21, 2027
March 30, 2026
March 1, 2026
4.2 years
August 30, 2021
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD) - Phase I
Maximum dose achievable without dose limiting toxicities (DLT's)
Minimum of 3 months after start of treatment on each dose level
Measure of proportion of patients with disease control - Phase II
Stable disease by RECIST or PCWG3 criteria after 16 weeks of treatment on study.
Minimum of 16 weeks after start of treatment, per patient
Secondary Outcomes (1)
Change in Quality of Life (QOL) score
Minimum of 16 weeks of treatment on study
Study Arms (6)
Dose level 1
EXPERIMENTALDose level 2a
EXPERIMENTALDose level 2b
EXPERIMENTALDose level 3a
EXPERIMENTALDose level 3b
EXPERIMENTALDose level 4
EXPERIMENTALInterventions
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Dasatinib 20mg daily
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily Dasatanib 20mg daily
Eligibility Criteria
You may qualify 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 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 adoptive cell therapy are allowed.
- 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. Subjects 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.
- +3 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2021
First Posted
September 5, 2021
Study Start
March 3, 2022
Primary Completion (Estimated)
May 21, 2026
Study Completion (Estimated)
May 21, 2027
Last Updated
March 30, 2026
Record last verified: 2026-03