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

NCT01981668 | Withdrawn Phase 1

• 1 other identifier: CABAZ-L-06233
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Toxicity

  1 year

Study Arms (1)

Cabazitaxel, Eligard and Radiotherapy

EXPERIMENTAL

This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the 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.

Drug: cabazitaxel

Interventions

cabazitaxel DRUG

Concurrent cabazitaxel, radiotherapy and Eligard for 3 years

Also known as: Jevtana

Cabazitaxel, Eligard and Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk prostate cancer

You may not qualify if:

• mets

Sponsors & Collaborators

• Nova Scotia Cancer Centre: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Derek R Wilke, MD,MSc,FRCPC

  department of radiation oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 11, 2013
• Primary Completion: September 1, 2013
• Last Updated: March 19, 2014

Record last verified: 2014-03