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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose

Outcome 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.

Outcome Time Frame:

Within 12 weeks following treatment

Safety Issue:

Yes

Principal Investigator

Elisabeth I Heath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wayne State University

Authority:

United States: Food and Drug Administration

Study ID:

APC-100-01

NCT ID:

NCT01436214

Start Date:

August 2011

Completion Date:

August 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Karmanos Cancer InstituteDetroit, Michigan  48201
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669