A Phase 1 interventional study of AZD2171 and Paclitaxel in Carcinoma, Non-Small-Cell Lung, sponsored by AstraZeneca. Terminated at 2 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-01.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 6 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Paclitaxel/Carboplatin
Drug: Paclitaxel · Drug: Carboplatin
Paclitaxel/Carboplatin + AZD2171
Drug: AZD2171 · Drug: Paclitaxel · Drug: Carboplatin
oral tablet
Also known as: cediranib, RECENTIN™
intravenous infusion
Also known as: Taxol®
intravenous injection
Also known as: CBDCA, Paraplatin®
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
PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS)
Time frame: time to progression
PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel
Time frame: 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 frame: time to death
This study is terminated, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
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