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

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ClinicalTrials.gov Identifier: NCT00686036
Recruitment Status : Terminated (Slow recruitment)
First Posted : May 29, 2008
Results First Posted : May 24, 2011
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: vandetanib Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Vandetanib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: vandetanib
300 mg orally, once daily for up to 18 months
Drug: vandetanib
300 mg orally, once daily for up to 18 months
Other Name: Zactima
Placebo Comparator: Placebo
orally, once daily for up to 18 months
Drug: Placebo



Primary Outcome Measures :
  1. Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants 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 ]
  2. 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 ]
  3. Serum Testosterone Levels [ Time Frame: Change from baseline at each visit post-randomization until until week 78 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of prostate cancer
  • Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
  • Recent completion of first hormone treatment [intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue]
  • Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00686036     History of Changes
Other Study ID Numbers: D4200L00010
First Posted: May 29, 2008    Key Record Dates
Results First Posted: May 24, 2011
Last Update Posted: December 21, 2016
Last Verified: October 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
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