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ZD6474(Vandetanib) + Alimta Combo Study

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00506051
Collaborator
(none)
21
Enrollment
2
Arms
75
Duration (Months)

Study Details

Study Description

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
  • Drug: ZD6474 (vandetanib) 100mg
  • Drug: pemetrexed
  • Drug: ZD6474 (vandetanib) 300mg
 Phase 1

Study Design

Study Type:
Interventional
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 :
Jul 1, 2005
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: ZD6474 (vandetanib) 100mg

Drug: ZD6474 (vandetanib) 100mg
once daily oral tablet
Other Names:
  • ZACTIMA™

    • Drug: pemetrexed
    intravenous infusion
    Other Names:
  • Alimta®

    		•
    Experimental: ZD6474 (vandetanib) 300mg

    Drug: pemetrexed
    intravenous infusion
    Other Names:
  • Alimta®

    • Drug: ZD6474 (vandetanib) 300mg
    Other Names:
  • ZACTIMA™

    		•

    Outcome Measures

    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. [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. [assessed at each visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00506051
    Other Study ID Numbers:
    • D4200C00041
    First Posted:
    Jul 25, 2007
    Last Update Posted:
    Aug 25, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Genzyme, a Sanofi Company
    Non-small cell lung cancer
    lung cancer
    alimta
    vandetanib
    phase 1
    Additional relevant MeSH terms:
    Lung Neoplasms
    Pemetrexed

    Study Results

    No Results Posted as of Aug 25, 2016