Health Trials

COAST Therapy in Advanced Solid Tumors and Prostate Cancer

ConditionsProstate Cancer RecurrentSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Hydroxychloroquine, Metformin, Sirolimus
  • Hydroxychloroquine, Metformin, Sirolimus, Dasatanib
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir
  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib

Treatment groups

76 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov