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OpenTrials
Completed

NCT Number: NCT00506051

ZD6474(Vandetanib) + Alimta Combo Study

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.

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Key information

Conditions

Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Small Cell Lung Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD6474 (vandetanib) 100mg

Drug

once daily oral tablet

Other names: ZACTIMA™

Pemetrexed

Drug

intravenous infusion

Other names: Alimta®

ZD6474 (vandetanib) 300mg

Drug

Other names: ZACTIMA™

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2006
Study completion
2011
First posted
Jul 25, 2007
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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