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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00539331 |
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Date of registration:
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02/10/2007 |
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Primary sponsor: |
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Public title:
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Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients
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Scientific title:
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A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00539331 |
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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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Countries of recruitment
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Japan
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Contacts
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Name:
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Jane Robertson |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Xiaojin Shin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Masahiro Fukuoka, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sakai hospital Kinki University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Having histologically or cytologically confirmed NSCLC
- Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery
recurrent NSCLC
- WHO performance status 0-1
Exclusion Criteria:
- Untreated unstable brain or meningeal metastases
- Patient with inappropriate laboratory tests values
- Patient with poorly controlled hypertension
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: AZD2171
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Drug: Carboplatin
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Drug: Paclitaxel
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Primary Outcome(s)
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PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer
[Time Frame: Assessed at each visit during Part A]
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PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS)
[Time Frame: time to progression]
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Secondary Outcome(s)
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PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel
[Time Frame: Assessed at each visit during Part A]
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PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival
[Time Frame: time to death]
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Secondary ID(s)
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D8480C00040
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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