MedTrace Logo

COAST Therapy in Advanced Solid Tumors and Prostate Cancer

NCT05036226 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Prostate Cancer Recurrent
  • Solid Tumor, Adult

Interventions

COMBINATION_PRODUCT

Hydroxychloroquine, Metformin, Sirolimus

Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily

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

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

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

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

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

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2027-05-21
Completion
2028-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036226 on ClinicalTrials.gov