ZD6474(Vandetanib) + Alimta Combo Study

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. Identifier: NCT00506051
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : August 25, 2016
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma Non-Small Cell Lung Lung Cancer Drug: ZD6474 (vandetanib) 100mg Drug: pemetrexed Drug: ZD6474 (vandetanib) 300mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : July 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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™

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00506051

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

Additional Information:
Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00506051     History of Changes
Other Study ID Numbers: D4200C00041
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 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