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Vitamin E Analog

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
No Placebo-Only Group

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: APC-100Experimental Treatment1 Intervention

Find a Location

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 Nov 2025