ZD6474(Vandetanib) + Alimta Combo Study

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00506051

Enrollment

Registered

2007-07-25

Start date

2005-07-31

Completion date

2011-10-31

Last updated

2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Lung Cancer, Non-Small Cell Lung

Keywords

Non-small cell lung cancer, lung cancer, alimta, vandetanib, phase 1

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.

Interventions

DRUGZD6474 (vandetanib) 100mg

once daily oral tablet

DRUGpemetrexed

intravenous infusion

DRUGZD6474 (vandetanib) 300mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026