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ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

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ClinicalTrials.gov Identifier: NCT00404924
Recruitment Status : Completed
First Posted : November 29, 2006
Results First Posted : March 26, 2012
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: ZD6474 (vandetanib) Other: Best Supportive Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Placebo Comparator: 1
Best Supportive Care
Other: Best Supportive Care
standard of care

Experimental: 2
Vandetanib + Best Supportive Care
Drug: ZD6474 (vandetanib)
once daily oral tablet
Other Name: ZACTIMA™

Other: Best Supportive Care
standard of care




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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

  4. 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)

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404924


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Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00404924     History of Changes
Other Study ID Numbers: D4200C00044
EUDRACT Number 2006-002384-12
First Posted: November 29, 2006    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: September 30, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Non-Small-Cell Lung Carcinoma
Adenocarcinoma
Squamous Cell Carcinoma
Large Cell Carcinoma

Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms