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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
APC-100
Sponsored by
Adamis Pharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Karmanos Cancer Institute
  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

APC-100

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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.

Full Information

First Posted
August 31, 2011
Last Updated
July 15, 2015
Sponsor
Adamis Pharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01436214
Brief Title
Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adamis Pharmaceuticals Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
APC-100
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
APC-100
Intervention Description
Daily oral, dose escalation, 28-day cycle(s)
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose
Description
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.
Time Frame
Within 12 weeks following treatment
Secondary Outcome Measure Information:
Title
Plasma Pharmacokinetics (PK) profile of APC-100
Description
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.
Time Frame
Pre-Dose, Cycle 1:Day 1, Cycle 2:Day 2,Pre-Dose on Day 1 of each additional cycle
Title
Assess number, types, and severity of toxicity and adverse events
Description
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)
Time Frame
12 weeks
Title
Assess preliminary evidence of anti-tumor activity through PSA response
Description
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.
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth I Heath, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Cetnar, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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