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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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: APC-100
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Adamis Pharmaceuticals Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APC-100 Drug: APC-100
Daily oral, dose escalation, 28-day cycle(s)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436214

Locations
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Nicole Nechiporchik     313-576-9814     nechipon@karmanos.org    
Principal Investigator: Elisabeth Heath            
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53705
Contact: Mary Jane Staab, BSN, RN     608-263-7107     Mjs@medicine.wisc.edu    
Principal Investigator: Jeremy Cetnar, MD            
Sponsors and Collaborators
Adamis Pharmaceuticals Corporation
Investigators
Principal Investigator: Elisabeth I Heath, MD Wayne State University
Principal Investigator: Jeremy Cetnar, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Adamis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01436214     History of Changes
Other Study ID Numbers: APC-100-01
Study First Received: August 31, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013