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Slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vandetanib | Experimental | 300 mg orally, once daily for up to 18 months |
|
| Placebo | Placebo Comparator | orally, once daily for up to 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vandetanib | Drug | 300 mg orally, once daily for up to 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 78 weeks during off-treatment phase of ADT | |
| Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Calgary | Alberta | Canada | |||
| Research Site |
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)
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vandetanib | Vandetanib 300 mg tablet |
| FG001 | Placebo | Placebo to match vandetanib 300 mg tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug |
|
| From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL |
| Serum Testosterone Levels | Change from baseline at each visit post-randomization until until week 78 |
| Edmonton |
| Alberta |
| Canada |
| Research Site | Victoria | British Columbia | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Greenfield Park | Quebec | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Sherbrooke | Quebec | Canada |
| Research Site | Granby | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vandetanib | Vandetanib 300 mg tablet |
| BG001 | Placebo | Placebo to match vandetanib 300 mg tablet |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. | Posted | 52 weeks |
|
| |||||||||||||||||||||||
| Secondary | 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) | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. | Posted | 78 weeks during off-treatment phase of ADT |
|
| |||||||||||||||||||||||
| Secondary | Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL) | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. | Posted | From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL |
|
| |||||||||||||||||||||||
| Secondary | Serum Testosterone Levels | Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed. | Posted | Change from baseline at each visit post-randomization until until week 78 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vandetanib | Vandetanib 300 mg tablet | 1 | 9 | 9 | 9 | ||
| EG001 | Placebo | Placebo to match vandetanib 300 mg tablet | 1 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis Viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Alanine aminotrasferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema peripheral | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 |
| ||
| Listless | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Hepatic Lesion | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Helicobacter infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Tinea cruris | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Murmur | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Cyst | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
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