Efficacy and Safety of Zactima™ in Patients With Castration-Refractory Metastatic Prostate Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00659438

Purpose

This randomized, double-blind phase II trial is 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. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.

Condition	Intervention	Phase
Prostate Cancer	Drug: ZD6474 (Vandetanib) Drug: Bicalutamide Drug: Placebo	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the effect of ZD6474 (Zactima™) on biological progression free rate at 4 months based on PSA level in patients with castration-refractory metastatic prostate cancer, without any clinical symptom related to disease progression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to PSA progression [ Designated as safety issue: No ]
Time to onset of cancer related clinical symptoms [ Designated as safety issue: No ]
PSA response rate [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Progression rate from the radionuclide bone scanning in a sub-group of patients [ Designated as safety issue: No ]
Tolerability and safety profile of ZD6474 (Zactima™) [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bicalutamide 150mg + ZD6474 300mg	Drug: ZD6474 (Vandetanib) 300mg orally, once daily Drug: Bicalutamide 150mg orally, once daily
2: Placebo Comparator Bicalutamide 150mg + placebo	Drug: Bicalutamide 150mg orally, once daily Drug: Placebo orally, once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659438

Contacts

Contact: AstraZeneca France Clinical Study Information

+ 33.1.41.29.40.00

Locations

France
Research Site	Recruiting
BORDEAUX CEDEX, France
Research Site	Not yet recruiting
CRETEIL, France
Research Site	Not yet recruiting
PARIS, France
Research Site	Recruiting
PARIS CEDEX 05, France
Research Site	Recruiting
VILLEJUIF, France
Research Site	Not yet recruiting
PARIS CEDEX 5, France
Research Site	Recruiting
REIMS CEDEX, France
Research Site	Not yet recruiting
PARIS CEDEX 10, France

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Peter Langmuir - Medical Sceince Director )
Study ID Numbers:	D4200C00080
Study First Received:	April 10, 2008
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00659438 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Androgen Antagonists
Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Disease Progression

Bicalutamide
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009