Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01436214|
Recruitment Status : Unknown
Verified July 2015 by Adamis Pharmaceuticals Corporation.
Recruitment status was: Active, not recruiting
First Posted : September 19, 2011
Last Update Posted : July 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: APC-100||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2a, Open-Label, Dose-Escalation and Safety Study of APC-100 [Pentamethylchromanol, 2,2,5,7,8-Pentamethyl-6] in Men With Advanced Prostate Cancer|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2017|
Daily oral, dose escalation, 28-day cycle(s)
- Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose [ Time Frame: Within 12 weeks following treatment ]Determination of the MTD based on documentation of dose-limiting toxicities (DLTs) and adverse events. Eighteen patients will be accrued for this part of the study. The MTD will be determined based on both the acute DLTs (within the first cycle of treatment) and late (within cycles 2 through 3) DLTs of APC-100. The establishment of a recommended phase 2a dose will be based on toxicity (DLTs within the first 28 days) and tolerability (DLTs within the first 12 weeks) of APC-100.
- Plasma Pharmacokinetics (PK) profile of APC-100 [ Time Frame: Pre-Dose, Cycle 1:Day 1, Cycle 2:Day 2,Pre-Dose on Day 1 of each additional cycle ]Single dose and steady state pharmacokinetics of APC-100 by oral administration daily for 28 consecutive days on a 28-day cycle will be determined. The following PK parameters (half-life, Cmax, Tmax, AUC, CI, CIr and V) will be determined.
- Assess number, types, and severity of toxicity and adverse events [ Time Frame: 12 weeks ]Assessment of incidence, severity, duration, causality and types of toxicity and adverse event severities assessed by NCI Common Toxicity Criteria (NCI CTC), version 4.0)
- Assess preliminary evidence of anti-tumor activity through PSA response [ Time Frame: pre-study, Cycle 1: Day 1 (unless prestudy was performed within 7 days of study entry), Cycle 2: Day 1, End of Treatment ]Assessment of preliminary anti-tumor activity will be based on PSA response (absolute and percentage change compared to prestudy (baseline) and RECIST criteria, if the patient has measurable disease.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436214
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Elisabeth I Heath, MD||Wayne State University|
|Principal Investigator:||Jeremy Cetnar, MD||University of Wisconsin, Madison|