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Spots Global Cancer Trial Database for A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Seattle Cancer Care Alliance, Seattle, Washington, United States

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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