Phase 2
Completed N=124
Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine
Source: ClinicalTrials.gov NCT00753714 ↗Enrolled (actual)
124
Serious AEs
41.1%
Results posted
Sep 2012
Primary outcomePrimary: Progression Free Survival — 183; 169 days
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 chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
183; 169 | — |
| SECONDARY Overall Survival |
262; 305 | — |
| SECONDARY Overall Objective Response |
9; 8 | — |
| SECONDARY Duration of Response |
225; 214 | — |
| SECONDARY The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine |
378; 381 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00753714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.