A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day
lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by
the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for
three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow
for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis
of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4
(docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of
PSK/placebo lead-in and during cycles 1 and 4.
Phase:
Phase 1
Details
Lead Sponsor:
Bastyr University
Collaborators:
Fred Hutchinson Cancer Research Center University of Washington