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

Adamis Pharmaceuticals

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: APC-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436214

APC-100-01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

APC-100

Experimental group

Treatment:

Drug: APC-100