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

NCT01436214 | Unknown Phase 1 DMC

• 1 other identifier: APC-100-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 12 weeks following treatment

Secondary Outcomes (3)

• Plasma Pharmacokinetics (PK) profile of APC-100

  Pre-Dose, Cycle 1:Day 1, Cycle 2:Day 2,Pre-Dose on Day 1 of each additional cycle

• Assess number, types, and severity of toxicity and adverse events

  12 weeks

• Assess preliminary evidence of anti-tumor activity through PSA response

  pre-study, Cycle 1: Day 1 (unless prestudy was performed within 7 days of study entry), Cycle 2: Day 1, End of Treatment

Study Arms (1)

APC-100

EXPERIMENTAL

Drug: APC-100

Interventions

APC-100 DRUG

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

APC-100

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adamis Pharmaceuticals Corporation: lead

Study Sites (2)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Elisabeth I Heath, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Jeremy Cetnar, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 19, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

US (2)