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COAST Therapy for Prostate Cancer (COAST Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-2
Measurable / evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 3 months after start of treatment on each dose level
Awards & highlights

COAST Trial Summary

This trial is testing the safety and effectiveness of a combination of 5 drugs for treating solid tumor cancers.

Who is the study for?
Adults with advanced solid tumors or prostate cancer, who have tried standard treatments without success. They must be relatively healthy, with stable vital signs and organ function, not on certain blood thinners or statins, and willing to use contraception if they can have children.Check my eligibility
What is being tested?
The trial is testing a combination of five drugs: hydroxychloroquine, nelfinavir, metformin, dasatinib, and sirolimus for their safety and effectiveness in treating solid tumor cancers including advanced prostate cancer.See study design
What are the potential side effects?
Potential side effects may include digestive issues (like nausea), blood sugar changes due to metformin; skin problems or nerve damage from hydroxychloroquine; mouth sores or lung problems from sirolimus; heart complications from dasatinib; and increased infection risk due to nelfinavir.

COAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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My cancer can be measured or evaluated by scans or blood tests.
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I have advanced cancer.
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I am 18 years old or older.
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My liver function tests are within the required range.

COAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 3 months after start of treatment on each dose level
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 3 months after start of treatment on each dose level for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) - Phase I
Disease
Secondary outcome measures
Change in Quality of Life (QOL) score

COAST Trial Design

6Treatment groups
Experimental Treatment
Group I: Dose level 4Experimental Treatment1 Intervention
Group II: Dose level 3bExperimental Treatment1 Intervention
Group III: Dose level 3aExperimental Treatment1 Intervention
Group IV: Dose level 2bExperimental Treatment1 Intervention
Group V: Dose level 2aExperimental Treatment1 Intervention
Group VI: Dose level 1Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
947 Previous Clinical Trials
7,397,992 Total Patients Enrolled
19 Trials studying Prostate Cancer
779 Patients Enrolled for Prostate Cancer

Media Library

Hydroxychloroquine, Metformin, Sirolimus (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05036226 — Phase 1 & 2
Prostate Cancer Research Study Groups: Dose level 1, Dose level 2a, Dose level 2b, Dose level 3a, Dose level 3b, Dose level 4
Prostate Cancer Clinical Trial 2023: Hydroxychloroquine, Metformin, Sirolimus Highlights & Side Effects. Trial Name: NCT05036226 — Phase 1 & 2
Hydroxychloroquine, Metformin, Sirolimus (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036226 — Phase 1 & 2
~7 spots leftby Oct 2024