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Brief Title: A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
Official Title: A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
Study ID: NCT01685489
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Celestia Higano, MD
Affiliation: Seattle Cancer Care Alliance - University of Washington
Role: STUDY_DIRECTOR
Name: Cynthia A Wenner, Ph.D
Affiliation: Bastyr University
Role: STUDY_DIRECTOR
Name: Leanna J Standish, PhD, ND, LAc
Affiliation: Bastyr University
Role: PRINCIPAL_INVESTIGATOR
Name: Mary (Nora) L Disis, MD
Affiliation: University of Washington
Role: PRINCIPAL_INVESTIGATOR