Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01981668
Status:
WITHDRAWN
Last Update Posted:
2014-03-19
First Post:
2013-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation
Sponsor:
Nova Scotia Cancer Centre
Organization:
Study Overview
Official Title:
The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation
Status:
WITHDRAWN
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no Canadian centre interested in conducting study in a reasonable timeframe
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
Assuming that dose-limiting toxicity is not encountered, and both the maximum dose of Cabazitaxel is reached, in Part A of the study, and the maximum dose of Radiotherapy is reached in Part B of the study, the maximum number of patients required is as follows: Clinical Study Protocol - The JET study Date: September 11, 2012 Part A: 3 patients per level x 5 levels, plus 3 patients (for a total of 6) at the highest dose level of Cabazitaxel = 15 + 3 = 18 Part B: 3 patients per level x 3 levels, plus 3 patients (for a total of 6) at the highest dose level of Radiotherapy = 9 + 3 = 12 The total number of patients required is 30. Patients that do not complete concurrent chemotherapy, radiotherapy, and androgen deprivation therapy, for reasons other than DLT will be replaced.
Given our experience in chemo-radiation studies in a similar patient population, our Centre is anticipated to accrue 3 patients per month.
Assuming that dose-limiting toxicity is not encountered, and both the maximum dose of Cabazitaxel is reached, in Part A of the study, and the maximum dose of Radiotherapy is reached in Part B of the study, the maximum number of patients required is as follows: Clinical Study Protocol - The JET study Date: September 11, 2012 Part A: 3 patients per level x 5 levels, plus 3 patients (for a total of 6) at the highest dose level of Cabazitaxel = 15 + 3 = 18 Part B: 3 patients per level x 3 levels, plus 3 patients (for a total of 6) at the highest dose level of Radiotherapy = 9 + 3 = 12 The total number of patients required is 30. Patients that do not complete concurrent chemotherapy, radiotherapy, and androgen deprivation therapy, for reasons other than DLT will be replaced.
Given our experience in chemo-radiation studies in a similar patient population, our Centre is anticipated to accrue 3 patients per month.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: