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Trial record 1 of 1 for:    D4200L00009
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ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial (ZACFAST)

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ClinicalTrials.gov Identifier: NCT00752986
Recruitment Status : Terminated
First Posted : September 16, 2008
Results First Posted : October 6, 2014
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: ZD6474 (Vandetanib at the dose of 100 mg)
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
Drug: Fulvestrant
Drug: ZD6474 (Vandetanib at the dose of 300 mg)
Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Enrollment 39
Recruitment Details The study was prematurely terminated.
Pre-assignment Details 39 participants were randomized to receive vandetanib or placebo.
Arm/Group Title Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Hide Arm/Group Description 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 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 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).
Period Title: Overall Study
Started 16 12 11
Completed 11 11 9
Not Completed 5 1 2
Reason Not Completed
Withdrawal by Subject             2             1             2
Protocol Violation             3             0             0
Arm/Group Title Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg Total
Hide Arm/Group Description 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 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 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 of all reporting groups
Overall Number of Baseline Participants 16 12 11 39
Hide Baseline Analysis Population Description
No data were analyzed due to the premature study interruption and sample of patients was too low.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 12 participants 11 participants 39 participants
63.6
(44 to 78)
59.8
(48 to 79)
59.6
(43 to 74)
61.3
(43 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 12 participants 11 participants 39 participants
Female
16
 100.0%
12
 100.0%
11
 100.0%
39
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Event Free Survival
Hide Description Success rate (patients without progression and still on treatment at 24 weeks
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Hide Arm/Group Description:
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 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 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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Hide Arm/Group Description:
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 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 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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Hide Arm/Group Description:
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 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 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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes
Hide Description [Not Specified]
Time Frame Continuous assessment of safety.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Hide Arm/Group Description:
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 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 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 Number of Participants Analyzed 0 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 at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Hide Arm/Group Description 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 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 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).
All-Cause Mortality
Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/16 (18.75%)      2/12 (16.67%)      1/11 (9.09%)    
Blood and lymphatic system disorders       
Anaemia   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
Endocrine disorders       
diabetes complication   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
Gastrointestinal disorders       
gastroenteritis.   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
grade 3 diarrhoea   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Injury, poisoning and procedural complications       
severe arthralgia   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders       
right iliac fracture   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders       
grade 3 erythema   2/16 (12.50%)  2 0/12 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Vandetanib at the Dose of 100 mg Vandetanib at the Dose of 300 mg Placebo to Match Vandetanib 100 mg and 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/16 (75.00%)      11/12 (91.67%)      6/11 (54.55%)    
Blood and lymphatic system disorders       
AST ELEVATION   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
ANAEMIA   1/16 (6.25%)  3 0/12 (0.00%)  0 1/11 (9.09%)  1
NEUTROPENIA   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
LEUKOPENIA   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
HYPERCALCEMIA   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
HYPERTRANSAMINASEMIA   0/16 (0.00%)  0 2/12 (16.67%)  5 1/11 (9.09%)  1
PIASTRINOPENIA   0/16 (0.00%)  0 1/12 (8.33%)  3 0/11 (0.00%)  0
TRANSAMINASE INCREASE   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
HYPERPOTASSEMIA   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Cardiac disorders       
HYPERTENSION   3/16 (18.75%)  3 2/12 (16.67%)  4 0/11 (0.00%)  0
TACHICARDY   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
FLUSHING   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Ear and labyrinth disorders       
DIZZINESS   1/16 (6.25%)  1 1/12 (8.33%)  1 0/11 (0.00%)  0
VERTIGO   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Eye disorders       
LEFT EYE PAIN   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
EYE ANGIOEDEMA   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders       
RIGHT HYPOCHONDRIUM PAIN   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
DIARRHEA   3/16 (18.75%)  3 7/12 (58.33%)  14 0/11 (0.00%)  0
General disorders       
RECTAL BLEEDING   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
HEMORRHOIDS   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
TOOTH ACHE   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
NAUSEA   2/16 (12.50%)  2 3/12 (25.00%)  3 0/11 (0.00%)  0
VOMITING   1/16 (6.25%)  1 1/12 (8.33%)  2 0/11 (0.00%)  0
INSOMNIA   0/16 (0.00%)  0 3/12 (25.00%)  3 0/11 (0.00%)  0
HEADACHE   1/16 (6.25%)  1 2/12 (16.67%)  2 0/11 (0.00%)  0
ANOREXIA   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
ASTHENIA   2/16 (12.50%)  2 2/12 (16.67%)  2 0/11 (0.00%)  0
FEVER   2/16 (12.50%)  2 2/12 (16.67%)  2 0/11 (0.00%)  0
ONYCHOPATY   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
WEIGHT LOSS   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
LOSS OF APPETITE   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
SWEATING   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
ARTHRALGIA   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
FATIGUE   1/16 (6.25%)  2 0/12 (0.00%)  0 0/11 (0.00%)  0
Hepatobiliary disorders       
HEPATIC TOXICITY   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
Infections and infestations       
MUCOSITIS   0/16 (0.00%)  0 1/12 (8.33%)  2 0/11 (0.00%)  0
STOMATITIS   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
UMBILICAL MYCOSES   1/16 (6.25%)  2 0/12 (0.00%)  0 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders       
BONE PAIN   0/16 (0.00%)  0 3/12 (25.00%)  4 1/11 (9.09%)  1
JOINT PAIN   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
RIB FRACTURE   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
LUMBAR PAIN   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
MUSCOLOSKELETRICAL PAIN   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders       
NEUROPATHY (ARMS)   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
Psychiatric disorders       
ANXIETY   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
ANXIOUS-DEPRESSIVE SYNDROME   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
Renal and urinary disorders       
PROTEINURIA   0/16 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1
CYSTITIS   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
HAEMORRHAGIC CYSTITIS   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
THORACIC PAIN   0/16 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
PAIN RIGHT THORAX   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
BRONCHITIS   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders       
RASH   3/16 (18.75%)  6 6/12 (50.00%)  11 0/11 (0.00%)  0
HYPERPIGMENTATION   1/16 (6.25%)  1 1/12 (8.33%)  1 0/11 (0.00%)  0
ERYTHEMA   1/16 (6.25%)  1 2/12 (16.67%)  5 0/11 (0.00%)  0
SCALP ERITHEMA   1/16 (6.25%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
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: NCT00752986     History of Changes
Other Study ID Numbers: D4200L00009
EUDRACT 2008-000579-12
First Submitted: September 15, 2008
First Posted: September 16, 2008
Results First Submitted: September 15, 2014
Results First Posted: October 6, 2014
Last Update Posted: December 5, 2016