ZD6474(Vandetanib) + Alimta Combo Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00506051
First received: July 3, 2007
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

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
Carcinoma
Non-Small Cell Lung
Lung Cancer
Drug: ZD6474 (vandetanib)
Drug: pemetrexed
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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 AstraZeneca:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: ZD6474 (vandetanib)
    once daily oral tablet
    Other Name: ZACTIMA™
    Drug: pemetrexed
    intravenous infusion
    Other Name: Alimta®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00506051

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Richard deBoer, MD Western Hospital Footscray, Victoria, Australia
Study Director: Peter Langmuir AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00506051     History of Changes
Other Study ID Numbers: D4200C00041
Study First Received: July 3, 2007
Last Updated: November 23, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Non-small cell lung cancer
lung cancer
alimta
vandetanib
phase 1

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 30, 2014