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

This study is currently recruiting participants.

Verified January 2013 by Adamis Pharmaceuticals Corporation

Sponsor:

Information provided by (Responsible Party):

Adamis Pharmaceuticals Corporation

ClinicalTrials.gov Identifier:

NCT01436214

First received: August 31, 2011

Last updated: January 22, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2011

Last Updated Date

January 22, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose [ Time Frame: Within 12 weeks following treatment ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01436214 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: APC-100

Daily oral, dose escalation, 28-day cycle(s)

Study Arm (s)

Experimental: APC-100

Intervention: Drug: APC-100

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2015

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01436214

Other Study ID Numbers ^ICMJE

APC-100-01

Has Data Monitoring Committee

Yes

Responsible Party

Adamis Pharmaceuticals Corporation

Study Sponsor ^ICMJE

Adamis Pharmaceuticals Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Elisabeth I Heath, MD	Wayne State University
Principal Investigator:	Jeremy Cetnar, MD	University of Wisconsin, Madison

Information Provided By

Adamis Pharmaceuticals Corporation

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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