ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

Non-Small-Cell Lung Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404924
• Other study ID #: D4200C00044
• Secondary ID: EUDRACT Number 2
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2006
• Last updated: February 9, 2015
• Start date: November 2006
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1140
• Est. completion date: November 2014
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• ZD6474 (vandetanib)
once daily oral tablet

Other:
• Best Supportive Care
standard of care

Locations

Country	Name	City	State
Argentina	Research Site	Bahia Blanca
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	La Plata
Argentina	Research Site	Rosario
Argentina	Research Site	San Miguel de Tucuman
Argentina	Research Site	Santa Fe
Australia	Research Site	Fitzroy
Australia	Research Site	Perth
Australia	Research Site	St. Leonards
Australia	Research Site	Tugan
Australia	Research Site	Woodville South
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	Vienna
Belgium	Research Site	Antwerpen
Belgium	Research Site	Brussels (Woluwé-St-Lambert)
Belgium	Research Site	Charleroi
Belgium	Research Site	Edegem
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Toronto	Ontario
China	Research Site	Beijing
China	Research Site	Chengdu
China	Research Site	Dalian
China	Research Site	Guangzhou
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Wuhan
China	Research Site	Xi'an
France	Research Site	Brest Cedex
France	Research Site	Caen Cedex
France	Research Site	Lyon Cedex
France	Research Site	Marseille Cedex 9
France	Research Site	Nice Cedex
France	Research Site	Pierre Benite Cedex
France	Research Site	Toulon Armees
Germany	Research Site	Bad Berka
Germany	Research Site	Donaustauf
Germany	Research Site	Frankfurt
Germany	Research Site	Gauting
Germany	Research Site	Göttingen
Germany	Research Site	Halle
Germany	Research Site	Hannover
Germany	Research Site	Karlsruhe
Germany	Research Site	Leipzig
Germany	Research Site	Löwenstein
Germany	Research Site	Mannheim
Germany	Research Site	München
Hong Kong	Research Site	Hong Kong
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar Saba
Israel	Research Site	Tel-Hashomer
Israel	Research Site	Zerifin
Italy	Research Site	Ancona
Italy	Research Site	Bologna
Italy	Research Site	Catania
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Orbassano
Italy	Research Site	Parma
Italy	Research Site	Roma
Italy	Research Site	Rozzano
Italy	Research Site	S.Andrea delle Fratte
Italy	Research Site	Sondalo
Italy	Research Site	Udine
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Seongnam
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Mexico	Research Site	México
Mexico	Research Site	Zapopan
Netherlands	Research Site	St Maartenskliniek
Peru	Research Site	Lima
Philippines	Research Site	Cebu City
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Singapore	Research Site	Singapore
Spain	Research Site	Baracaldo(Vizcaya)
Spain	Research Site	Barcelona
Spain	Research Site	Santander
Spain	Research Site	Valencia
Taiwan	Research Site	Changhua
Taiwan	Research Site	Kao Hsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung Hsien
Taiwan	Research Site	Liou Ying Township
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Taiwan	Research Site	Tao-Yuan
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Khon Kaen
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Chelmsford
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Maidstone
United Kingdom	Research Site	Manchester
United States	Research Site	Germantown	Tennessee
United States	Research Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  China,  France,  Germany,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Peru,  Philippines,  Singapore,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression-Free Survival (PFS)	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	RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression	No
Secondary	Objective Response Rate (ORR)	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.	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.	No
Secondary	Disease Control Rate (DCR)	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	RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression	No
Secondary	Duration of Response (DoR)	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)	RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression	No
Secondary	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 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.	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	No

External Links

•   Link
•   AstraZeneca Clinical Trial Information - Outside US
•   Cancer Study Locator (US and Canada only)
•   CSR-D4200C00044.pdf