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The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation

NCT01981668 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-03-19

No results posted yet for this study

Summary

This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

cabazitaxel

Concurrent cabazitaxel, radiotherapy and Eligard for 3 years

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Nova Scotia Cancer Centre

    lead OTHER

Principal Investigators

  • Derek R Wilke, MD,MSc,FRCPC · department of radiation oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2013-09-30

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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 NCT01981668 on ClinicalTrials.gov