Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy (ZENITH)
This study has been terminated.
(Slow recruitment)
Sponsor:
AstraZeneca
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
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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
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 May 16, 2013