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

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adamis Pharmaceuticals Corporation

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