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ZD6474(Vandetanib) + Alimta Combo Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506051
First Posted: July 25, 2007
Last Update Posted: August 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
July 3, 2007
July 25, 2007
August 25, 2016
July 2005
May 2006   (Final data collection date for primary outcome measure)
To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam. [ Time Frame: assessed at each visit ]
To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam.
Complete list of historical versions of study NCT00506051 on ClinicalTrials.gov Archive Site
To investigate the pharmacokinetics of ZD6474 and Pemetrexed when given in combination to patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy, by assessment of appropriate pharmacokinetic (PK) parameters. [ Time Frame: assessed at each visit ]
To investigate the pharmacokinetics of ZD6474 and Pemetrexed when given in combination to patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy, by assessment of appropriate pharmacokinetic (PK) parameters.
Not Provided
Not Provided
 
ZD6474(Vandetanib) + Alimta Combo Study
A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.
The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma
  • Non-Small Cell Lung
  • Lung Cancer
  • Drug: ZD6474 (vandetanib) 100mg
    once daily oral tablet
    Other Name: ZACTIMA™
  • Drug: pemetrexed
    intravenous infusion
    Other Name: Alimta®
  • Drug: ZD6474 (vandetanib) 300mg
    Other Name: ZACTIMA™
  • Experimental: ZD6474 (vandetanib) 100mg
    Interventions:
    • Drug: ZD6474 (vandetanib) 100mg
    • Drug: pemetrexed
  • Experimental: ZD6474 (vandetanib) 300mg
    Interventions:
    • Drug: pemetrexed
    • Drug: ZD6474 (vandetanib) 300mg
de Boer R, Humblet Y, Wolf J, Nogová L, Ruffert K, Milenkova T, Smith R, Godwood A, Vansteenkiste J. An open-label study of vandetanib with pemetrexed in patients with previously treated non-small-cell lung cancer. Ann Oncol. 2009 Mar;20(3):486-91. doi: 10.1093/annonc/mdn674. Epub 2008 Dec 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
October 2011
May 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed advanced or metastatic non-small cell lung cancer
  • Failure of first-line chemotherapy
  • 1 or more measurable lesion by RECIST

Exclusion Criteria:

  • Previous chemotherapy or radiotherapy within 4 weeks
  • Significant cardiac events, arrythmias or other cardiac conditions
  • Unacceptable laboratory measurements
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00506051
D4200C00041
No
Not Provided
Not Provided
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP