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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01436214

Run by

Adamis Pharmaceuticals Corporation

People needed

60

Starts

2011-08-01

Expected to finish

2017-08-01

Last updated by the study team

2015-07-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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