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Trial record 1 of 1 for:    D4200L00010
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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: vandetanib
Drug: Placebo
Enrollment 17
Recruitment Details A total of 25 male patients signed informed consent at 12 centres in Canada between May 2008 and February 2010. Out of these 25 patients, 17 patients were randomized with 9 patients in the vandetanib treatment arm and 8 patients in the placebo arm.
Pre-assignment Details To be eligible for enrollment into the study, patients had to have received treatment with ADT for 36 weeks (± 4 weeks), with a pre-ADT PSA ≥ 5 ng/mL. Also, they should have had a screening PSA ≤ 1.0 ng/mL (within 6 weeks prior to study Day 1)
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description Vandetanib 300 mg tablet Placebo to match vandetanib 300 mg tablet
Period Title: Overall Study
Started 9 8
Completed 0 2
Not Completed 9 6
Reason Not Completed
Adverse Event             3             0
Withdrawal by Subject             3             1
Study terminated by AstraZeneca             2             1
PSA ≥ 10ng/mL             1             0
Other reasons not identified             0             4
Arm/Group Title Vandetanib Placebo Total
Hide Arm/Group Description Vandetanib 300 mg tablet Placebo to match vandetanib 300 mg tablet Total of all reporting groups
Overall Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 17 participants
72  (7.263) 71.5  (7.709) 71.5  (7.489)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 9 participants 8 participants 17 participants
9 8 17
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 9 participants 8 participants 17 participants
9 8 17
1.Primary Outcome
Title Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg tablet
Placebo to match vandetanib 300 mg tablet
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 78 weeks during off-treatment phase of ADT
Hide Outcome Measure Data
Hide Analysis Population Description
Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg tablet
Placebo to match vandetanib 300 mg tablet
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)
Hide Description [Not Specified]
Time Frame From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL
Hide Outcome Measure Data
Hide Analysis Population Description
Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg tablet
Placebo to match vandetanib 300 mg tablet
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Serum Testosterone Levels
Hide Description [Not Specified]
Time Frame Change from baseline at each visit post-randomization until until week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg tablet
Placebo to match vandetanib 300 mg tablet
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description Vandetanib 300 mg tablet Placebo to match vandetanib 300 mg tablet
All-Cause Mortality
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   1/8 (12.50%) 
Infections and infestations     
Bronchitis Viral  1  0/9 (0.00%)  1/8 (12.50%) 
Investigations     
Aspartate Aminotransferase Increased  1  1/9 (11.11%)  0/8 (0.00%) 
Alanine aminotrasferase increased  1  1/9 (11.11%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  0/9 (0.00%)  1/8 (12.50%) 
Interstitial Lung Disease  1  1/9 (11.11%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   8/8 (100.00%) 
Cardiac disorders     
Angina pectoris  1  0/9 (0.00%)  1/8 (12.50%) 
Eye disorders     
Eye pruritus  1  1/9 (11.11%)  0/8 (0.00%) 
Ocular hyperaemia  1  1/9 (11.11%)  0/8 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  7/9 (77.78%)  2/8 (25.00%) 
Nausea  1  3/9 (33.33%)  2/8 (25.00%) 
Oedema peripheral  1  2/9 (22.22%)  3/8 (37.50%) 
Constipation  1  2/9 (22.22%)  1/8 (12.50%) 
Flatulence  1  2/9 (22.22%)  0/8 (0.00%) 
Abdominal pain  1  0/9 (0.00%)  1/8 (12.50%) 
Abdominal pain upper  1  1/9 (11.11%)  0/8 (0.00%) 
Epigastric discomfort  1  1/9 (11.11%)  0/8 (0.00%) 
Faecal incontinence  1  1/9 (11.11%)  0/8 (0.00%) 
Gastrooesophageal reflux disease  1  1/9 (11.11%)  0/8 (0.00%) 
Haemorrhoids  1  1/9 (11.11%)  0/8 (0.00%) 
Proctitis  1  1/9 (11.11%)  0/8 (0.00%) 
Stomatitis  1  1/9 (11.11%)  0/8 (0.00%) 
Vomiting  1  1/9 (11.11%)  0/8 (0.00%) 
General disorders     
Fatigue  1  2/9 (22.22%)  3/8 (37.50%) 
Chills  1  2/9 (22.22%)  0/8 (0.00%) 
Asthenia  1  1/9 (11.11%)  0/8 (0.00%) 
Chest Pain  1  1/9 (11.11%)  1/8 (12.50%) 
Hepatobiliary disorders     
Hepatic Lesion  1  1/9 (11.11%)  0/8 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  2/9 (22.22%)  3/8 (37.50%) 
Carbuncle  1  0/9 (0.00%)  1/8 (12.50%) 
Helicobacter infection  1  1/9 (11.11%)  0/8 (0.00%) 
Lower respiratory tract infection  1  1/9 (11.11%)  0/8 (0.00%) 
Onychomycosis  1  0/9 (0.00%)  1/8 (12.50%) 
Tinea cruris  1  1/9 (11.11%)  0/8 (0.00%) 
Bronchitis  1  1/9 (11.11%)  0/8 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/9 (11.11%)  0/8 (0.00%) 
Investigations     
Electrocardiogram QT prolonged  1  3/9 (33.33%)  0/8 (0.00%) 
Blood creatinine increased  1  1/9 (11.11%)  0/8 (0.00%) 
Blood pressure increased  1  1/9 (11.11%)  0/8 (0.00%) 
Cardiac Murmur  1  0/9 (0.00%)  2/8 (25.00%) 
Weight decreased  1  1/9 (11.11%)  0/8 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/9 (33.33%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  2/9 (22.22%)  0/8 (0.00%) 
Arthralgia  1  1/9 (11.11%)  1/8 (12.50%) 
Back pain  1  1/9 (11.11%)  0/8 (0.00%) 
Muscle atrophy  1  1/9 (11.11%)  0/8 (0.00%) 
Muscle spasms  1  0/9 (0.00%)  1/8 (12.50%) 
Muscular weakness  1  1/9 (11.11%)  0/8 (0.00%) 
Musculoskeletal pain  1  0/9 (0.00%)  1/8 (12.50%) 
Myalgia  1  1/9 (11.11%)  1/8 (12.50%) 
Nervous system disorders     
Dizziness  3/9 (33.33%)  1/8 (12.50%) 
Headache  1  2/9 (22.22%)  0/8 (0.00%) 
Tremor  1  2/9 (22.22%)  0/8 (0.00%) 
Amnesia  1  1/9 (11.11%)  0/8 (0.00%) 
Balance disorder  1  1/9 (11.11%)  0/8 (0.00%) 
Burning sensation  1  0/9 (0.00%)  1/8 (12.50%) 
Hyperaesthesia  1  0/9 (0.00%)  1/8 (12.50%) 
Memory impairment  1  1/9 (11.11%)  0/8 (0.00%) 
Presyncope  1  1/9 (11.11%)  0/8 (0.00%) 
Psychiatric disorders     
Listless  1  3/9 (33.33%)  0/8 (0.00%) 
Renal and urinary disorders     
Haematuria  1  1/9 (11.11%)  0/8 (0.00%) 
Hypertonic bladder  1  0/9 (0.00%)  1/8 (12.50%) 
Nocturia  1  1/9 (11.11%)  0/8 (0.00%) 
Renal Cyst  1  1/9 (11.11%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/9 (33.33%)  1/8 (12.50%) 
Cough  1  0/9 (0.00%)  1/8 (12.50%) 
Epistaxis  1  1/9 (11.11%)  0/8 (0.00%) 
Oropharyngeal pain  1  1/9 (11.11%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  3/9 (33.33%)  0/8 (0.00%) 
Alopecia  1  0/9 (0.00%)  1/8 (12.50%) 
Dry skin  1  1/9 (11.11%)  0/8 (0.00%) 
Erythema  1  0/9 (0.00%)  1/8 (12.50%) 
Hair growth abnormal  1  0/9 (0.00%)  1/8 (12.50%) 
Photosensitivity reaction  1  1/9 (11.11%)  0/8 (0.00%) 
Skin discolouration  1  1/9 (11.11%)  0/8 (0.00%) 
Swelling face  1  1/9 (11.11%)  0/8 (0.00%) 
Vascular disorders     
Hot flush  1  1/9 (11.11%)  2/8 (25.00%) 
Pallor  1  2/9 (22.22%)  0/8 (0.00%) 
Hypertension  1  1/9 (11.11%)  0/8 (0.00%) 
Hypotension  1  0/9 (0.00%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
It was planned that approx 100 patients would be recruited over a period of approx 2 years, due to slow recruitment the study was terminated early. No statistical analyses was done and no conclusion can be drawn about the outcomes in this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00686036     History of Changes
Other Study ID Numbers: D4200L00010
First Submitted: May 27, 2008
First Posted: May 29, 2008
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: December 21, 2016