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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
932 Previous Clinical Trials
7,394,314 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still looking for participants for this experiment?

"Yes, the trial is ongoing and currently seeking participants. According to the information on clinicaltrials.gov, the study was first posted on March 3rd, 2022 and last updated April 4th, 2022. They are looking for 76 individuals across 1 site."

Answered by AI

What medical conditions are Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib most often prescribed for?

"Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, and Dasatinib are often used to treat q fever. However, these medications can also be helpful for other ailments like malaria, chordomas, and diabetes that has not responded to previous interventions."

Answered by AI

Do you know if there have been any previous research trials that studied Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib?

"439 ongoing studies are investigating the efficacy of Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, and Dasatinib. Of these trials, 75 have progressed to Phase 3. Most research is conducted in Pittsburgh; however, there are 7924 active clinical trial locations for this treatment worldwide."

Answered by AI

How many subjects are enrolled in this clinical trial?

"Yes, the information available on clinicaltrials.gov seems to suggest that this study is still looking for patients. The trial was first advertised on March 3rd, 2020 and has since been updated April 4th of this year. They are currently enrolling 76 individuals from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
COAST Therapy in Advanced Solid Tumors and Prostate Cancer
2022. "COAST Therapy in Advanced Solid Tumors and Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036226.
All > Prostate Cancer Columbia > Dasatinib
~12 spots leftby Oct 2024
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