ZD6474(Vandetanib) + Alimta Combo Study - Full Text View

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 I

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Pemetrexed disodium Pemetrexed Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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.

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
Estimated Study Completion Date:	March 2008

Intervention Details:

once daily oral tablet

intravenous infusion

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

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

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D4200C00041
First Received:	July 3, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00506051
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Non-small cell lung cancer

lung cancer

alimta

vandetanib

phase 1

Study placed in the following topic categories:

Folic Acid

Pemetrexed

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Antimetabolites

Respiratory Tract Neoplasms

Neoplasms

Antimetabolites, Antineoplastic

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Folic Acid Antagonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00506051