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ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ZD6474 (vandetanib)
Best Supportive Care
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring Non-Small-Cell Lung Carcinoma, Adenocarcinoma, Squamous Cell Carcinoma, Large Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Best Supportive Care

Vandetanib + Best Supportive Care

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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.
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
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)
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.

Full Information

First Posted
November 28, 2006
Last Updated
August 24, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00404924
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma
Keywords
Non-Small-Cell Lung Carcinoma, Adenocarcinoma, Squamous Cell Carcinoma, Large Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Best Supportive Care
Arm Title
2
Arm Type
Experimental
Arm Description
Vandetanib + Best Supportive Care
Intervention Type
Drug
Intervention Name(s)
ZD6474 (vandetanib)
Other Intervention Name(s)
ZACTIMA™
Intervention Description
once daily oral tablet
Intervention Type
Other
Intervention Name(s)
Best Supportive Care
Intervention Description
standard of care
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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 Frame
Time to death in months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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
Time Frame
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Title
Objective Response Rate (ORR)
Description
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.
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.
Title
Disease Control Rate (DCR)
Description
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
Time Frame
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Title
Duration of Response (DoR)
Description
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 Frame
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Title
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)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Bahia Blanca
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
La Plata
Country
Argentina
Facility Name
Research Site
City
Rosario
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Research Site
City
Santa Fe
Country
Argentina
Facility Name
Research Site
City
Fitzroy
Country
Australia
Facility Name
Research Site
City
Perth
Country
Australia
Facility Name
Research Site
City
St. Leonards
Country
Australia
Facility Name
Research Site
City
Tugan
Country
Australia
Facility Name
Research Site
City
Woodville South
Country
Australia
Facility Name
Research Site
City
Linz
Country
Austria
Facility Name
Research Site
City
Salzburg
Country
Austria
Facility Name
Research Site
City
Vienna
Country
Austria
Facility Name
Research Site
City
Antwerpen
Country
Belgium
Facility Name
Research Site
City
Brussels (Woluwé-St-Lambert)
Country
Belgium
Facility Name
Research Site
City
Charleroi
Country
Belgium
Facility Name
Research Site
City
Edegem
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Liège
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Chengdu
Country
China
Facility Name
Research Site
City
Dalian
Country
China
Facility Name
Research Site
City
Guangzhou
Country
China
Facility Name
Research Site
City
Nanjing
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
Facility Name
Research Site
City
Wuhan
Country
China
Facility Name
Research Site
City
Xi'an
Country
China
Facility Name
Research Site
City
Brest Cedex
Country
France
Facility Name
Research Site
City
Caen Cedex
Country
France
Facility Name
Research Site
City
Lyon Cedex
Country
France
Facility Name
Research Site
City
Marseille Cedex 9
Country
France
Facility Name
Research Site
City
Nice Cedex
Country
France
Facility Name
Research Site
City
Pierre Benite Cedex
Country
France
Facility Name
Research Site
City
Toulon Armees
Country
France
Facility Name
Research Site
City
Bad Berka
Country
Germany
Facility Name
Research Site
City
Donaustauf
Country
Germany
Facility Name
Research Site
City
Frankfurt
Country
Germany
Facility Name
Research Site
City
Gauting
Country
Germany
Facility Name
Research Site
City
Göttingen
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Karlsruhe
Country
Germany
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City
Leipzig
Country
Germany
Facility Name
Research Site
City
Löwenstein
Country
Germany
Facility Name
Research Site
City
Mannheim
Country
Germany
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Research Site
City
München
Country
Germany
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Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Kfar Saba
Country
Israel
Facility Name
Research Site
City
Tel-Hashomer
Country
Israel
Facility Name
Research Site
City
Zerifin
Country
Israel
Facility Name
Research Site
City
Ancona
Country
Italy
Facility Name
Research Site
City
Bologna
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Orbassano
Country
Italy
Facility Name
Research Site
City
Parma
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
S.Andrea delle Fratte
Country
Italy
Facility Name
Research Site
City
Sondalo
Country
Italy
Facility Name
Research Site
City
Udine
Country
Italy
Facility Name
Research Site
City
Goyang-si
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon
Country
Korea, Republic of
Facility Name
Research Site
City
México
Country
Mexico
Facility Name
Research Site
City
Zapopan
Country
Mexico
Facility Name
Research Site
City
St Maartenskliniek
Country
Netherlands
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Cebu City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Singapore
Country
Singapore
Facility Name
Research Site
City
Baracaldo(Vizcaya)
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Santander
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Changhua
Country
Taiwan
Facility Name
Research Site
City
Kao Hsiung
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung Hsien
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Liou Ying Township
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Tao-Yuan
Country
Taiwan
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
Country
Thailand
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Chelmsford
Country
United Kingdom
Facility Name
Research Site
City
Dundee
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25881079
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=342&filename=CSR-D4200C00044.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=342&filename=CSR-D4200C00044.pdf
Description
CSR-D4200C00044.pdf

Learn more about this trial

ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

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