|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00659438 |
|
Date of registration:
|
10/04/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
|
|
Scientific title:
|
A Randomized, Double-blind Phase II Trial to Assess the Efficacy and Safety of Bicalutamide (Casodex® ) Associated to ZD6474 (Zactima™ ) or to Placebo in Patients With Castration-refractory Metastatic Prostate Cancer Without Any Clinical Symptom Related to Disease Progression |
|
Date of first enrolment:
|
February 2008 |
|
Target sample size:
|
95 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00659438 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Clinical Sciences & Operations |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sanofi |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Males presented with a confirmed histological diagnosis of adenocarcinoma of the
prostate with evidence of metastases (including bone, lymph nodes, or other site)
radiologically or histologically documented and despite a serum testosterone =1.73
nmol/L (50 ng/dL) proving castration, evidence of biochemical progression of prostate
cancer, documented by a rise in PSA .
Exclusion Criteria:
- Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral
orchiectomy within the 30 days preceding Visit 1. Incompletely healed surgical
incision.
- Concomitant anticancer therapy other than surgical castration or continuous medical
castration.
- Biology restriction.
- Clinical significant cardiovascular event or presence of cardiac disease that in the
opinion of the Investigator increases the risk of ventricular arrhythmia.
- History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3),
symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia.
Subjects with atrial fibrillation controlled on medication are permitted.
- Hypertension not controlled by medical therapy
- ECG /QTc prolongation
- Presence of left bundle branch block (LBBB).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Prostate Cancer
|
|
Intervention(s)
|
|
Drug: Bicalutamide
|
|
Drug: ZD6474 (Vandetanib)
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months
[Time Frame: 4 months]
|
|
Secondary Outcome(s)
|
|
Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs
[Time Frame: 4 months]
|
|
Overall Survival (OS)
[Time Frame: End of study (July 2011)]
|
|
PSA Response Rate
[Time Frame: 4 months]
|
|
Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)
[Time Frame: 4 months]
|
|
Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only)
[Time Frame: 4 months]
|
|
Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only)
[Time Frame: 4 months]
|
|
Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)
[Time Frame: 4 months]
|
|
Progression Rate From the Radionuclide Bone Scanning
[Time Frame: 4 months]
|
|
Secondary ID(s)
|
|
2007-001891-35
|
|
D4200C00080
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|