ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
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|ClinicalTrials.gov Identifier: NCT00404924|
Recruitment Status : Completed
First Posted : November 29, 2006
Results First Posted : March 26, 2012
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Drug: ZD6474 (vandetanib) Other: Best Supportive Care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||November 2014|
Placebo Comparator: 1
Best Supportive Care
Other: Best Supportive Care
standard of care
Vandetanib + Best Supportive Care
Drug: ZD6474 (vandetanib)
once daily oral tablet
Other Name: ZACTIMA™
Other: Best Supportive Care
standard of care
- Overall Survival (OS) [ Time Frame: Time to death in months ]Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).
- Progression-Free Survival (PFS) [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression ]Median time (in months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment
- Objective Response Rate (ORR) [ Time Frame: Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression. ]
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.
The categories for best objective response are CR, PR, stable disease (SD)>= 8 weeks, progressive disease (PD) or NE.
- Disease Control Rate (DCR) [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression ]Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks
- Duration of Response (DoR) [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression ]Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)
- Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF) [ Time Frame: Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit ]Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404924
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|Study Director:||Clinical Sciences & Operations||Sanofi|