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ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial (ZACFAST)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00752986
First received: September 15, 2008
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: September 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

the study was prtematurely terminated with 41 enrolled patients and 39 randomized, out of the 135 scheduled by protocol.

A total of 8 serious adverse events have been reported in 6 patients overall. 2 patients had 2 SAEs


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
41 pts enrolled , 39 randomized. two patients never received the drug.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Vandetanib at the Dose of 100 mg     Vandetanib at the Dose of 300 mg     Placebo to Match Vandetanib 100 mg and 300 mg  
STARTED     16     12     11  
COMPLETED     11     11     9  
NOT COMPLETED     5     1     2  
Withdrawal by Subject                 2                 1                 2  
Protocol Violation                 3                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No data were analyzed due to the premature study interruption and sample of patients was too low.

Reporting Groups
  Description
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).
Total Total of all reporting groups

Baseline Measures
    Vandetanib at the Dose of 100 mg     Vandetanib at the Dose of 300 mg     Placebo to Match Vandetanib 100 mg and 300 mg     Total  
Number of Participants  
[units: participants]
  16     12     11     39  
Age  
[units: years]
Mean ( Full Range )
  63.6  
  ( 44 to 78 )  
  59.8  
  ( 48 to 79 )  
  59.6  
  ( 43 to 74 )  
  61.3  
  ( 43 to 79 )  
Gender  
[units: Partecipants]
       
Female     16     12     11     39  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Event Free Survival   [ 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. ]

2.  Secondary:   Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)   [ 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. ]

3.  Secondary:   Overall Survival   [ 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. ]

4.  Secondary:   Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes   [ Time Frame: Continuous assessment of safety. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Constanza Oliveros, MD
Organization: Medical Dept AstraZeneca
phone: 00390298011
e-mail: ClinicalTrialTransparency@ASTRAZENECA.COM


Publications:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00752986     History of Changes
Other Study ID Numbers: D4200L00009, EUDRACT 2008-000579-12
Study First Received: September 15, 2008
Results First Received: September 15, 2014
Last Updated: October 6, 2014
Health Authority: ITALY: Comitato Etico Dell´IRCCS Istituto Nazionale Per Lo Studio E LA Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli