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COAST Therapy in Advanced Solid Tumors and Prostate Cancer (COAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05036226
Recruitment Status : Not yet recruiting
First Posted : September 5, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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, nelfinavir, metformin, dasatinib and sirolimus.

Condition or disease Intervention/treatment Phase
Prostate Cancer Recurrent Solid Tumor, Adult Combination Product: Hydroxychloroquine, Metformin, Sirolimus Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Dasatanib Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I/II Trial
Estimated Study Start Date : October 15, 2021
Estimated Primary Completion Date : October 15, 2024
Estimated Study Completion Date : October 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Dose level 1 Combination Product: Hydroxychloroquine, Metformin, Sirolimus
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily

Experimental: Dose level 2a Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Dasatanib
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Dasatinib 20mg daily

Experimental: Dose level 2b Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily

Experimental: Dose level 3a Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib
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

Experimental: Dose level 3b Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily

Experimental: Dose level 4 Combination Product: Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib
Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily Dasatanib 20mg daily




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) - Phase I [ Time Frame: Minimum of 3 months after start of treatment on each dose level ]
    Maximum dose achievable without dose limiting toxicities (DLT's)

  2. Measure of proportion of patients with disease control - Phase II [ Time Frame: Minimum of 16 weeks after start of treatment, per patient ]
    Stable disease by RECIST or PCWG3 criteria after 16 weeks of treatment on study.


Secondary Outcome Measures :
  1. Change in Quality of Life (QOL) score [ Time Frame: Minimum of 16 weeks of treatment on study ]
    To document the change in QOL (via disease-specific FACT questionnaire, composite score) in patients treated with COAST) after two and four cycles of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05036226


Contacts
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Contact: Alan Brisendine 843-792-9007 brisend@musc.edu
Contact: Jasmin Brooks brooksjm@musc.edu

Sponsors and Collaborators
Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05036226    
Other Study ID Numbers: 103352
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Metformin
Sirolimus
Hydroxychloroquine
Nelfinavir
Dasatinib
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Protein Kinase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents