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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01436214
• Other study ID #: APC-100-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: August 31, 2011
• Last updated: July 15, 2015
• Start date: August 2011
• Est. completion date: August 2017

Study information

• Verified date: July 2015
• Source: Adamis Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• APC-100
Daily oral, dose escalation, 28-day cycle(s)

Locations

Country	Name	City	State
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Adamis Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose	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.	Within 12 weeks following treatment	Yes
Secondary	Plasma Pharmacokinetics (PK) profile of APC-100	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.	Pre-Dose, Cycle 1:Day 1, Cycle 2:Day 2,Pre-Dose on Day 1 of each additional cycle	No
Secondary	Assess number, types, and severity of toxicity and adverse events	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)	12 weeks	Yes
Secondary	Assess preliminary evidence of anti-tumor activity through PSA response	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.	pre-study, Cycle 1: Day 1 (unless prestudy was performed within 7 days of study entry), Cycle 2: Day 1, End of Treatment	No