ZD6474(Vandetanib) + Alimta Combo Study

Genzyme, a Sanofi Company21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma Non-Small Cell Lung Lung Cancer

Interventions

ZD6474 (vandetanib) 100mgDRUG

once daily oral tablet

pemetrexedDRUG

intravenous infusion

ZD6474 (vandetanib) 300mgDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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