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The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. As the design of Study 040 is similar to that of Study BR24, AstraZeneca has suspended recruitment into Study 040.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Paclitaxel/Carboplatin |
|
| 2 | Experimental | Paclitaxel/Carboplatin + AZD2171 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer | Assessed at each visit during Part A | |
| PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS) | time to progression |
| Measure | Description | Time Frame |
|---|---|---|
| PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel | Assessed at each visit during Part A | |
| PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival | time to death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson | AstraZeneca | Study Director |
| Masahiro Fukuoka, MD | Sakai hospital Kinki University School of Medicine | Principal Investigator |
| Xiaojin Shin, MD | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Osaka | Japan | ||||
| Research Site |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C500926 | cediranib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | intravenous infusion |
|
|
| Carboplatin | Drug | intravenous injection |
|
|
| Tokyo |
| Japan |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |