Status:
COMPLETED
Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in che...
Eligibility Criteria
Inclusion
- Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into study
- One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria
- Chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
- Female or male aged 70 years or above
Exclusion
- Patients must not have received prior anti-cancer therapy except in the adjuvant setting
- Inadequate end-organ function or Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial
- Significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[SVC\] syndrome, New York Heart Association \[NYHA\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
- History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00753714
Start Date
October 1 2008
End Date
December 1 2011
Last Update
October 17 2016
Active Locations (15)
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1
Research Site
Meldola, (fc), Italy
2
Research Site
Avellino, AV, Italy
3
Research Site
Bari, BA, Italy
4
Research Site
Treviglio, BG, Italy