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

NCT ID: NCT01436214

Last Updated: 2015-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APC-100

Group Type EXPERIMENTAL

APC-100

Intervention Type DRUG

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

Interventions

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APC-100

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Adamis Pharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth I Heath, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Jeremy Cetnar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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APC-100-01

Identifier Type: -

Identifier Source: org_study_id

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