BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC
|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|
|Primary Completion Date :||March 2013|
|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.
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|