Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment apc-100
Phase phase 1/phase 2
Sponsor Adamis Pharmaceuticals Corporation
Start date August 2011
End date August 2016
Trial size 60 participants
Trial identifier NCT01436214, APC-100-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
apc-100
Daily oral, dose escalation, 28-day cycle(s)

Primary Outcomes

Measure
Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose
time frame: Within 12 weeks following treatment

Secondary Outcomes

Measure
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
Assess number, types, and severity of toxicity and adverse events
time frame: 12 weeks
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

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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
Principal investigator Elisabeth I Heath, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Adamis Pharmaceuticals Corporation.
Location data was received from the National Cancer Institute and was last updated in January 2016.