Trial Outcomes & Findings for ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial (NCT NCT00752986)
NCT ID: NCT00752986
Last Updated: 2016-12-05
Results Overview
Success rate (patients without progression and still on treatment at 24 weeks
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.
Results posted on
2016-12-05
Participant Flow
The study was prematurely terminated.
39 participants were randomized to receive vandetanib or placebo.
Participant milestones
| Measure |
Vandetanib at the Dose of 100 mg
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Vandetanib at the Dose of 300 mg
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Placebo to Match Vandetanib 100 mg and 300 mg
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
12
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
2
|
Reasons for withdrawal
| Measure |
Vandetanib at the Dose of 100 mg
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Vandetanib at the Dose of 300 mg
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Placebo to Match Vandetanib 100 mg and 300 mg
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
|
Overall Study
Protocol Violation
|
3
|
0
|
0
|
Baseline Characteristics
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
Baseline characteristics by cohort
| Measure |
Vandetanib at the Dose of 100 mg
n=16 Participants
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Vandetanib at the Dose of 300 mg
n=12 Participants
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Placebo to Match Vandetanib 100 mg and 300 mg
n=11 Participants
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.6 years
n=93 Participants
|
59.8 years
n=4 Participants
|
59.6 years
n=27 Participants
|
61.3 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.Success rate (patients without progression and still on treatment at 24 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Continuous assessment of safety.Outcome measures
Outcome data not reported
Adverse Events
Vandetanib at the Dose of 100 mg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Vandetanib at the Dose of 300 mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo to Match Vandetanib 100 mg and 300 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib at the Dose of 100 mg
n=16 participants at risk
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Vandetanib at the Dose of 300 mg
n=12 participants at risk
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Placebo to Match Vandetanib 100 mg and 300 mg
n=11 participants at risk
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Endocrine disorders
diabetes complication
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
grade 3 erythema
|
12.5%
2/16 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
right iliac fracture
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
severe arthralgia
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
gastroenteritis.
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Gastrointestinal disorders
grade 3 diarrhoea
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
Other adverse events
| Measure |
Vandetanib at the Dose of 100 mg
n=16 participants at risk
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Vandetanib at the Dose of 300 mg
n=12 participants at risk
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
|
Placebo to Match Vandetanib 100 mg and 300 mg
n=11 participants at risk
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
|
|---|---|---|---|
|
Gastrointestinal disorders
RIGHT HYPOCHONDRIUM PAIN
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
AST ELEVATION
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
General disorders
RECTAL BLEEDING
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
General disorders
HEMORRHOIDS
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.2%
1/16 • Number of events 3
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/16
|
25.0%
3/12 • Number of events 4
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
HYPERCALCEMIA
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
HYPERTRANSAMINASEMIA
|
0.00%
0/16
|
16.7%
2/12 • Number of events 5
|
9.1%
1/11 • Number of events 1
|
|
General disorders
TOOTH ACHE
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
LEFT EYE PAIN
|
0.00%
0/16
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
18.8%
3/16 • Number of events 3
|
58.3%
7/12 • Number of events 14
|
0.00%
0/11
|
|
Infections and infestations
MUCOSITIS
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
0.00%
0/11
|
|
General disorders
NAUSEA
|
12.5%
2/16 • Number of events 2
|
25.0%
3/12 • Number of events 3
|
0.00%
0/11
|
|
General disorders
VOMITING
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 2
|
0.00%
0/11
|
|
Hepatobiliary disorders
HEPATIC TOXICITY
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
General disorders
INSOMNIA
|
0.00%
0/16
|
25.0%
3/12 • Number of events 3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
RASH
|
18.8%
3/16 • Number of events 6
|
50.0%
6/12 • Number of events 11
|
0.00%
0/11
|
|
General disorders
HEADACHE
|
6.2%
1/16 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/11
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
PIASTRINOPENIA
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
0.00%
0/11
|
|
General disorders
ANOREXIA
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
General disorders
ASTHENIA
|
12.5%
2/16 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
0.00%
0/11
|
|
Cardiac disorders
HYPERTENSION
|
18.8%
3/16 • Number of events 3
|
16.7%
2/12 • Number of events 4
|
0.00%
0/11
|
|
General disorders
FEVER
|
12.5%
2/16 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
0.00%
0/11
|
|
General disorders
ONYCHOPATY
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
JOINT PAIN
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
RIB FRACTURE
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
STOMATITIS
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
NEUROPATHY (ARMS)
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.2%
1/16 • Number of events 1
|
16.7%
2/12 • Number of events 5
|
0.00%
0/11
|
|
General disorders
WEIGHT LOSS
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
General disorders
LOSS OF APPETITE
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Ear and labyrinth disorders
DIZZINESS
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Psychiatric disorders
ANXIOUS-DEPRESSIVE SYNDROME
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
THORACIC PAIN
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Cardiac disorders
TACHICARDY
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
|
Ear and labyrinth disorders
VERTIGO
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
General disorders
SWEATING
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Eye disorders
EYE ANGIOEDEMA
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Renal and urinary disorders
CYSTITIS
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
LUMBAR PAIN
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
TRANSAMINASE INCREASE
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
PAIN RIGHT THORAX
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Cardiac disorders
FLUSHING
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
SCALP ERITHEMA
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Infections and infestations
UMBILICAL MYCOSES
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
|
Renal and urinary disorders
HAEMORRHAGIC CYSTITIS
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
HYPERPOTASSEMIA
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
General disorders
ARTHRALGIA
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
|
General disorders
FATIGUE
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
MUSCOLOSKELETRICAL PAIN
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
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