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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 September 2016 |
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Main ID: |
NCT00071188 |
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Date of registration:
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14/10/2003 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
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Scientific title:
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A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00071188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Finland
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France
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Germany
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India
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Italy
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South Africa
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Spain
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Thailand
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United States
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent
- 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- No prior chemotherapy/biological therapy/radiation therapy
- One or more measurable lesions
- Life expectancy more than 12 weeks
Exclusion Criteria:
- Brain metastases or spinal cord compression
- Currently active skin disease
- History of significant hemoptysis
- Abnormal blood chemistry
- Cardiac abnormalities
- Recent significant cardiac event
- Coexisting malignancies
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Non-Small-Cell Lung
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Intervention(s)
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Drug: Paclitaxel
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Drug: Carboplatin
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Drug: ZD6474
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Secondary ID(s)
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D4200C00007
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D4200C0007A (randomization)
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D4200C00007(run-in)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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