Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

ZD6474(Vandetanib) + Alimta Combo Study

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: July 3, 2007
Last updated: August 24, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Non-Small Cell Lung
Lung Cancer
Drug: ZD6474 (vandetanib) 100mg
Drug: pemetrexed
Drug: ZD6474 (vandetanib) 300mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: July 2005
Study Completion Date: October 2011
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZD6474 (vandetanib) 100mg Drug: ZD6474 (vandetanib) 100mg
once daily oral tablet
Other Name: ZACTIMA™
Drug: pemetrexed
intravenous infusion
Other Name: Alimta®
Experimental: ZD6474 (vandetanib) 300mg Drug: pemetrexed
intravenous infusion
Other Name: Alimta®
Drug: ZD6474 (vandetanib) 300mg
Other Name: ZACTIMA™


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00506051

Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00506051     History of Changes
Other Study ID Numbers: D4200C00041
Study First Received: July 3, 2007
Last Updated: August 24, 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Non-small cell lung cancer
lung cancer
phase 1

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on May 25, 2017