ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
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)
2 other identifiers
interventional
1,140
21 countries
97
Brief Summary
This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
Longer than P75 for phase_3
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 28, 2006
CompletedFirst Posted
Study publicly available on registry
November 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedResults Posted
Study results publicly available
March 26, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedSeptember 30, 2016
August 1, 2016
2.9 years
November 28, 2006
April 27, 2011
August 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
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).
Time to death in months
Secondary Outcomes (5)
Progression-Free Survival (PFS)
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Objective Response Rate (ORR)
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.
Disease Control Rate (DCR)
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Duration of Response (DoR)
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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)
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
Study Arms (2)
1
PLACEBO COMPARATORBest Supportive Care
2
EXPERIMENTALVandetanib + Best Supportive Care
Interventions
Eligibility Criteria
You may qualify if:
- Patients with Non-small cell lung cancer for which the standard cancer treatments of surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate treatments for you.
You may not qualify if:
- Patients who have had standard cancer treatments of surgery, chemotherapy or other systemic anti-cancer therapy within 4 weeks before start of study therapy.
- Three or more prior chemotherapy regimens.
- Significant cardiovascular events.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
Research Site
Tucson, Arizona, United States
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Germantown, Tennessee, United States
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Bahía Blanca, Argentina
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Ciudad de Buenos Aires, Argentina
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La Plata, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Santa Fe, Argentina
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Fitzroy, Australia
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Perth, Australia
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St Leonards, Australia
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Tugan, Australia
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Woodville South, Australia
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Antwerp, Belgium
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Brussels (Woluwé-St-Lambert), Belgium
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Charleroi, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Edmonton, Alberta, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Chengdu, China
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Dalian, China
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Guangzhou, China
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Nanjing, China
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Shanghai, China
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Wuhan, China
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Xi'an, China
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Brest, France
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Caen, France
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Lyon, France
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Marseille, France
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Nice, France
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Pierre-Bénite, France
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Toulon Armees, France
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Bad Berka, Germany
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Donaustauf, Germany
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Frankfurt, Germany
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Gauting, Germany
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Göttingen, Germany
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Halle, Germany
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Hanover, Germany
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Karlsruhe, Germany
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Leipzig, Germany
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Löwenstein, Germany
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Mannheim, Germany
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München, Germany
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Hong Kong, Hong Kong
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Jerusalem, Israel
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Kfar Saba, Israel
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Tel Litwinsky, Israel
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Ẕerifin, Israel
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Ancona, Italy
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Bologna, Italy
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Catania, Italy
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Genova, Italy
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Milan, Italy
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Orbassano, Italy
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Parma, Italy
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Roma, Italy
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Rozzano, Italy
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S.Andrea Delle Fratte, Italy
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Sondalo, Italy
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Udine, Italy
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México, Mexico
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Zapopan, Mexico
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Saint Maartenskliniek, Netherlands
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Lima, Peru
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Cebu City, Philippines
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Manila, Philippines
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Quezon City, Philippines
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Singapore, Singapore
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Goyang-si, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Baracaldo(Vizcaya), Spain
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Barcelona, Spain
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Santander, Spain
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Valencia, Spain
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung Hsien, Taiwan
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Liou Ying Township, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Khon Kaen, Thailand
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Birmingham, United Kingdom
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Chelmsford, United Kingdom
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Dundee, United Kingdom
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Maidstone, United Kingdom
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Manchester, United Kingdom
Related Publications (1)
Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.
PMID: 25881079DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2006
First Posted
November 29, 2006
Study Start
November 1, 2006
Primary Completion
October 1, 2009
Study Completion
November 1, 2014
Last Updated
September 30, 2016
Results First Posted
March 26, 2012
Record last verified: 2016-08