ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

NCT ID: NCT00404924

Last Updated: 2016-09-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Best Supportive Care

Group Type PLACEBO_COMPARATOR

Best Supportive Care

Intervention Type OTHER

standard of care

2

Vandetanib + Best Supportive Care

Group Type EXPERIMENTAL

ZD6474 (vandetanib)

Intervention Type DRUG

once daily oral tablet

Best Supportive Care

Intervention Type OTHER

standard of care

Interventions

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ZD6474 (vandetanib)

once daily oral tablet

Intervention Type DRUG

Best Supportive Care

standard of care

Intervention Type OTHER

Other Intervention Names

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ZACTIMA™

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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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

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Countries

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

References

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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.

Reference Type DERIVED
PMID: 25881079 (View on PubMed)

Other Identifiers

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EUDRACT Number 2006-002384-12

Identifier Type: -

Identifier Source: secondary_id

D4200C00044

Identifier Type: -

Identifier Source: org_study_id

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