Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy (ZENITH)

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborator:
Canadian Urology Research Consortium
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00686036
First received: May 27, 2008
Last updated: April 27, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.


Condition Intervention Phase
Prostate Cancer
Drug: vandetanib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To Assess the Effect of Oral Vandetanib Compared to Placebo on the Proportion of Subjects Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of ADT. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Assess the Effect of Oral Vandetanib Compared to Placebo on the Proportion of Subjects Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) [ Time Frame: 78 weeks during off-treatment phase of ADT ] [ Designated as safety issue: No ]
  • To Determine the Effect Oral Vandetanib Compared to Placebo on Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL) [ Time Frame: From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL ] [ Designated as safety issue: No ]
  • To Investigate the Effect Oral Vandetanib Compared to Placebo on Serum Testosterone Levels [ Time Frame: Change from baseline at each visit post-randomization until until week 78 ] [ Designated as safety issue: No ]
  • To Characterise the Safety Profile of Vandetanib at a Daily Dose of 300mg/Day Based on the Adverse Events, Laboratory Variables, ECG and Drug Tolerability [ Time Frame: From the time of randomization to week 78 ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: May 2008
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: vandetanib
300 mg orally, once daily for up to 18 months
Other Name: Zactima
Placebo Comparator: 2 Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of prostate cancer
  • PSA greater than or equal to 5 ng/mL
  • Recent completion of first hormone treatment (intermittent androgen deprivation with an LHRH analogue)

Exclusion Criteria:

  • Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)
  • Bone or soft tissue metastases
  • Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686036

Locations
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Canada, British Columbia
Research Site
Victoria, British Columbia, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Greenfield Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Canada
Research Site
Granby, Canada
Sponsors and Collaborators
AstraZeneca
Canadian Urology Research Consortium
Investigators
Principal Investigator: L Klotz, MD CURC; Sunnybrook Hospital
Study Director: Marc Zarenda AstraZeneca Canada
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Peter Langmuir, MD, Medical Science Senior Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00686036     History of Changes
Other Study ID Numbers: D4200L00010
Study First Received: May 27, 2008
Results First Received: April 27, 2011
Last Updated: April 27, 2011
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
prostate cancer
hormone treatment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014