Clinical trial NCT00404924: ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non-Small-Cell Lung Carcinoma
Adenocarcinoma
Squamous Cell Carcinoma
Large Cell Carcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 1140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Time to death in months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
measure: Objective Response Rate (ORR)
timeFrame: 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.
measure: Disease Control Rate (DCR)
timeFrame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
measure: Duration of Response (DoR)
timeFrame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
measure: 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)
timeFrame: 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
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Germantown
country: United States
facility: Research Site
state: Tennessee
city: Bahia Blanca
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Fitzroy
country: Australia
facility: Research Site
city: Perth
country: Australia
facility: Research Site
city: St. Leonards
country: Australia
facility: Research Site
city: Tugan
country: Australia
facility: Research Site
city: Woodville South
country: Australia
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Brussels (Woluwé-St-Lambert)
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Beijing
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Dalian
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Brest Cedex
country: France
facility: Research Site
city: Caen Cedex
country: France
facility: Research Site
city: Lyon Cedex
country: France
facility: Research Site
city: Marseille Cedex 9
country: France
facility: Research Site
city: Nice Cedex
country: France
facility: Research Site
city: Pierre Benite Cedex
country: France
facility: Research Site
city: Toulon Armees
country: France
facility: Research Site
city: Bad Berka
country: Germany
facility: Research Site
city: Donaustauf
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Löwenstein
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar Saba
country: Israel
facility: Research Site
city: Tel-Hashomer
country: Israel
facility: Research Site
city: Zerifin
country: Israel
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: S.Andrea delle Fratte
country: Italy
facility: Research Site
city: Sondalo
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Seongnam
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: México
country: Mexico
facility: Research Site
city: Zapopan
country: Mexico
facility: Research Site
city: St Maartenskliniek
country: Netherlands
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Baracaldo(Vizcaya)
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Kao Hsiung
country: Taiwan
facility: Research Site
city: Kaohsiung Hsien
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Liou Ying Township
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Chelmsford
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Maidstone
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.