Status:
UNKNOWN
Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer
Lead Sponsor:
Adamis Pharmaceuticals Corporation
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01436214
Start Date
August 1 2011
End Date
August 1 2017
Last Update
July 16 2015
Active Locations (2)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705