Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496275

Enrollment

Registered

2007-07-04

Start date

2006-08-31

Completion date

2007-05-31

Last updated

2016-08-26

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

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC, ZACTIMA

Brief summary

To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Interventions

DRUGZactima (ZD6474)

DRUGVinorelbine plus cisplatin

DRUGGemcitabine plus cisplatin

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 non small cell lung cancer (stage IIIB-IV) * Life expectancy greater than 12 weeks * At least 1 measurable lesion greater than 10mm in smallest diameter.

Exclusion criteria

* Prior treatment with anticancer agent * Brain metastases * Major surgery within last 4 weeks

Design outcomes

Primary

Measure	Time frame
Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin	—

Secondary

Measure	Time frame
Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin	—
Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered	Predetermined timepoints after dose administration

Outcome results

None listed

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