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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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, 2014
Last verified: January 2014

August 31, 2011
January 22, 2014
August 2011
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01436214 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: APC-100
Daily oral, dose escalation, 28-day cycle(s)
Experimental: APC-100
Intervention: Drug: APC-100
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2015
August 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
United States
 
NCT01436214
APC-100-01
Yes
Adamis Pharmaceuticals Corporation
Adamis Pharmaceuticals Corporation
Not Provided
Principal Investigator: Elisabeth I Heath, MD Wayne State University
Principal Investigator: Jeremy Cetnar, MD University of Wisconsin, Madison
Adamis Pharmaceuticals Corporation
January 2014

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