BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC
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|ClinicalTrials.gov Identifier: NCT00410189|
Recruitment Status : Completed
First Posted : December 12, 2006
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
- To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.
- Determine the overall response rate
- Determine the overall survival
- Determine the time to disease progression
- Assess the safety/toxicity of the study treatment
- Assess biomarker modulation in the tumor tissue and serum samples from the treatment
- Assess plasma and intra-tumor concentrations of study treatment
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: ZD6474||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open Label Study of ZD6474 in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
ZD6474 300 mg by mouth daily for 28 Days.
300 mg by mouth daily for 28 Days.
- 8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease) [ Time Frame: Baseline to 8 Weeks ]The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.
- 8 Week Progression-Free Survival [ Time Frame: Every 8 weeks till disease progression. ]Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.
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): NCT00410189
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anne S. Tsao, MD||M.D. Anderson Cancer Center|