Trial Outcomes & Findings for Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy (NCT NCT00686036)
NCT ID: NCT00686036
Last Updated: 2016-12-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
52 weeks
Results posted on
2016-12-21
Participant Flow
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.
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)
Participant milestones
| Measure |
Vandetanib
Vandetanib 300 mg tablet
|
Placebo
Placebo to match vandetanib 300 mg tablet
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Vandetanib
Vandetanib 300 mg tablet
|
Placebo
Placebo to match vandetanib 300 mg tablet
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Study terminated by AstraZeneca
|
2
|
1
|
|
Overall Study
PSA ≥ 10ng/mL
|
1
|
0
|
|
Overall Study
Other reasons not identified
|
0
|
4
|
Baseline Characteristics
Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
Baseline characteristics by cohort
| Measure |
Vandetanib
n=9 Participants
Vandetanib 300 mg tablet
|
Placebo
n=8 Participants
Placebo to match vandetanib 300 mg tablet
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 Years
STANDARD_DEVIATION 7.263 • n=5 Participants
|
71.5 Years
STANDARD_DEVIATION 7.709 • n=7 Participants
|
71.5 Years
STANDARD_DEVIATION 7.489 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 78 weeks during off-treatment phase of ADTPopulation: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mLPopulation: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline at each visit post-randomization until until week 78Population: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Vandetanib
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib
n=9 participants at risk
Vandetanib 300 mg tablet
|
Placebo
n=8 participants at risk
Placebo to match vandetanib 300 mg tablet
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/9
|
12.5%
1/8
|
|
Infections and infestations
Bronchitis Viral
|
0.00%
0/9
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
11.1%
1/9
|
0.00%
0/8
|
|
Investigations
Aspartate Aminotransferase Increased
|
11.1%
1/9
|
0.00%
0/8
|
|
Investigations
Alanine aminotrasferase increased
|
11.1%
1/9
|
0.00%
0/8
|
Other adverse events
| Measure |
Vandetanib
n=9 participants at risk
Vandetanib 300 mg tablet
|
Placebo
n=8 participants at risk
Placebo to match vandetanib 300 mg tablet
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
77.8%
7/9
|
25.0%
2/8
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9
|
25.0%
2/8
|
|
General disorders
Fatigue
|
22.2%
2/9
|
37.5%
3/8
|
|
Gastrointestinal disorders
Oedema peripheral
|
22.2%
2/9
|
37.5%
3/8
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
2/9
|
37.5%
3/8
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
3/9
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
3/9
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness
|
33.3%
3/9
|
12.5%
1/8
|
|
Psychiatric disorders
Listless
|
33.3%
3/9
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
3/9
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
3/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9
|
12.5%
1/8
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
2/9
|
0.00%
0/8
|
|
General disorders
Chills
|
22.2%
2/9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
2/9
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
22.2%
2/9
|
0.00%
0/8
|
|
Nervous system disorders
Tremor
|
22.2%
2/9
|
0.00%
0/8
|
|
Vascular disorders
Hot flush
|
11.1%
1/9
|
25.0%
2/8
|
|
Vascular disorders
Pallor
|
22.2%
2/9
|
0.00%
0/8
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/9
|
12.5%
1/8
|
|
Eye disorders
Eye pruritus
|
11.1%
1/9
|
0.00%
0/8
|
|
Eye disorders
Ocular hyperaemia
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Epigastric discomfort
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Faecal incontinence
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Proctitis
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9
|
0.00%
0/8
|
|
General disorders
Asthenia
|
11.1%
1/9
|
0.00%
0/8
|
|
General disorders
Chest Pain
|
11.1%
1/9
|
12.5%
1/8
|
|
Hepatobiliary disorders
Hepatic Lesion
|
11.1%
1/9
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9
|
12.5%
1/8
|
|
Infections and infestations
Carbuncle
|
0.00%
0/9
|
12.5%
1/8
|
|
Infections and infestations
Helicobacter infection
|
11.1%
1/9
|
0.00%
0/8
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
1/9
|
0.00%
0/8
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/9
|
12.5%
1/8
|
|
Infections and infestations
Tinea cruris
|
11.1%
1/9
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9
|
0.00%
0/8
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9
|
0.00%
0/8
|
|
Investigations
Blood pressure increased
|
11.1%
1/9
|
0.00%
0/8
|
|
Investigations
Cardiac Murmur
|
0.00%
0/9
|
25.0%
2/8
|
|
Investigations
Weight decreased
|
11.1%
1/9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
11.1%
1/9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.1%
1/9
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9
|
12.5%
1/8
|
|
Nervous system disorders
Amnesia
|
11.1%
1/9
|
0.00%
0/8
|
|
Nervous system disorders
Balance disorder
|
11.1%
1/9
|
0.00%
0/8
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/9
|
12.5%
1/8
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/9
|
12.5%
1/8
|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9
|
0.00%
0/8
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9
|
0.00%
0/8
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9
|
0.00%
0/8
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/9
|
12.5%
1/8
|
|
Renal and urinary disorders
Nocturia
|
11.1%
1/9
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal Cyst
|
11.1%
1/9
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/9
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
11.1%
1/9
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
11.1%
1/9
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
11.1%
1/9
|
0.00%
0/8
|
|
Vascular disorders
Hypertension
|
11.1%
1/9
|
0.00%
0/8
|
|
Vascular disorders
Hypotension
|
0.00%
0/9
|
12.5%
1/8
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER