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

Must not have

Patients who are receiving, coumadin, apixaban, argatroban or rivaroxaban

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 3 months after start of treatment on each dose level

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking blood thinners like coumadin or apixaban.

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I have severe heart issues, recent heart attack, or irregular heartbeats.

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I do not have an active infection needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum of 3 months after start of treatment on each dose level

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.