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 chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
124
100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle UP to 6 cycles or UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Research Site
Meldola, (fc), Italy
Research Site
Avellino, AV, Italy
Research Site
Bari, BA, Italy
Progression Free Survival
Time frame: Oct 2008- dec 2011
Overall Survival
Time frame: Oct 2008- dec 2011
Overall Objective Response
Time frame: Oct 2008- dec 2011
Duration of Response
Time frame: Oct 2008- dec 2011
The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine
The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes
Time frame: Oct 2008- Dec 2011
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Treviglio, BG, Italy
Research Site
Bologna, BO, Italy
Research Site
Genova, GE, Italy
Research Site
Taormina, ME, Italy
Research Site
Milan, MI, Italy
Research Site
Perugia, PG, Italy
Research Site
Ravenna, RA, Italy
...and 5 more locations