ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

August 24, 2016 updated by: Genzyme, a Sanofi Company

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • 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, Argentina
        • Research Site
  • Australia
      • Fitzroy, Australia
        • Research Site
      • Perth, Australia
        • Research Site
      • St. Leonards, Australia
        • Research Site
      • Tugan, Australia
        • Research Site
      • Woodville South, Australia
        • Research Site
  • Austria
      • Linz, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
  • Belgium
      • 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, Belgium
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • Ontario
      • Oshawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • China
      • 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, China
        • Research Site
  • France
      • 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, France
        • Research Site
  • Germany
      • 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, Germany
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • Israel
      • Jerusalem, Israel
        • Research Site
      • Kfar Saba, Israel
        • Research Site
      • Tel-Hashomer, Israel
        • Research Site
      • Zerifin, Israel
        • Research Site
  • Italy
      • 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, Italy
        • Research Site
  • Korea, Republic of
      • Goyang-si, Korea, Republic of
        • Research Site
      • Seongnam, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Suwon, Korea, Republic of
        • Research Site
  • Mexico
      • México, Mexico
        • Research Site
      • Zapopan, Mexico
        • Research Site
  • Netherlands
      • St Maartenskliniek, Netherlands
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Spain
      • Baracaldo(Vizcaya), Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
  • Taiwan
      • 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, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Chelmsford, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Maidstone, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • Tennessee
      • Germantown, Tennessee, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Best Supportive Care
Other: Best Supportive Care
standard of care
Experimental: 2
Vandetanib + Best Supportive Care
Other: Best Supportive Care
standard of care
Drug: ZD6474 (vandetanib)
once daily oral tablet
Other Names:
  • ZACTIMA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Time to death in months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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
Objective Response Rate (ORR)
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.

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.
Disease Control Rate (DCR)
Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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
Duration of Response (DoR)
Time Frame: RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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
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 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4200C00044
  • EUDRACT Number 2006-002384-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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