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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 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
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
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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
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