Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer

Phase 1

• Conditions: Prostate Cancer
• Interventions: Drug: APC-100

• Registration Number: NCT01436214
• Lead Sponsor: Adamis Pharmaceuticals Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-16
• Primary Completion: 2016-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Patients with histopathologically proven adenocarcinoma of the prostate
• Patients must have progressive disease
• Patients must have had prior treatment with bilateral orchiectomy or androgen deprivation therapy with an LHRH-blocker with evidence of treatment failure

Exclusion Criteria

• Patients treated with other secondary hormonal therapies
• Patients with prior chemotherapy given for castrate-resistant prostate cancer
• Patients with prior radiation therapy completed less than 4 weeks prior enrollment
• Patients with prior investigational therapies within 4 weeks before treatment with APC-100
• Evidence of active second malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APC-100	APC-100	-

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose	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.

Secondary Outcome Measures

Name	Time	Method
Assess number, types, and severity of toxicity and adverse events	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	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.
Plasma Pharmacokinetics (PK) profile of APC-100	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.

Trial Locations

Locations (2)

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States