APC-100 for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Elisabeth I Heath, MD

Research Sponsored by Adamis Pharmaceuticals Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-study, cycle 1: day 1 (unless prestudy was performed within 7 days of study entry), cycle 2: day 1, end of treatment

Awards & highlights

Study Summary

This study is a phase 1/2a, open label, dose escalation and safety study of APC-100 (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-study, cycle 1: day 1 (unless prestudy was performed within 7 days of study entry), cycle 2: day 1, end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-study, cycle 1: day 1 (unless prestudy was performed within 7 days of study entry), cycle 2: day 1, end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-study, cycle 1: day 1 (unless prestudy was performed within 7 days of study entry), cycle 2: day 1, end of treatment 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) and recommended Phase 2a Dose

Secondary outcome measures

Assess number, types, and severity of toxicity and adverse events

Assess preliminary evidence of anti-tumor activity through PSA response

Plasma Pharmacokinetics (PK) profile of APC-100

Trial Design

1Treatment groups

Experimental Treatment

Group I: APC-100Experimental Treatment1 Intervention

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Who is running the clinical trial?

Adamis Pharmaceuticals CorporationLead Sponsor

3 Previous Clinical Trials

248 Total Patients Enrolled

Elisabeth I Heath, MDPrincipal InvestigatorWayne State University

Jeremy Cetnar, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

~4 spots leftby May 2025

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