Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line Clinical Trial
Official title:
A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
| Verified date | August 2016 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
| Status | Completed |
| Enrollment | 129 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV) - Failure of first-line platinum-based chemotherapy Exclusion Criteria: - Mixed small cell or non-small-cell histology - Bronchoalveolar carcinoma - Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin) - Prior treatment with docetaxel |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Chomutov | |
| Czech Republic | Research Site | Hradec | |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Plzen | |
| Czech Republic | Research Site | Praha | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Deszk | |
| Hungary | Research Site | Torokbalint | |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Billings | Montana |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Coos Bay | Oregon |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Great Neck | New York |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pittsfield | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Genzyme, a Sanofi Company |
United States, Czech Republic, Hungary,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Outcome Progression free survival | |||
| Secondary | Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes; | |||
| Secondary | Objective response rate and duration of response | |||
| Secondary | QoL and lung cancer subscale (LCS) from the FACT-L questionnaire | |||
| Secondary | WHO performance status | |||
| Secondary | Time to death |