Trial | NCT01436214  Report issue

Title

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

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    apc-100 ...

  • Study Participants

    60
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.
Study Started
Aug 31
2011
Primary Completion
Aug 31
2016
Anticipated
Study Completion
Aug 31
2017
Anticipated
Last Update
Jul 16
2015
Estimate

Drug APC-100

Daily oral, dose escalation, 28-day cycle(s)

APC-100 Experimental

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
No Results Posted