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

NCT01685489 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-10-27

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Docetaxel, PSK®

DRUG

Docetaxel, Placebo

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • Bastyr University

    lead OTHER

Principal Investigators

  • Celestia Higano, MD · Seattle Cancer Care Alliance - University of Washington

  • Cynthia A Wenner, Ph.D · Bastyr University

  • Leanna J Standish, PhD, ND, LAc · Bastyr University

  • Mary (Nora) L Disis, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01685489 on ClinicalTrials.gov