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NCT00496275 Clinical Trial

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

Non Small Cell Lung Cancer Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00496275
Other study ID # D4200C00054
Secondary ID
Status Completed
Phase Phase 1
First received July 3, 2007
Last updated August 25, 2016
Start date August 2006
Est. completion date May 2007

Study information
Verified date August 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Zactima (ZD6474)

• Vinorelbine plus cisplatin

• Gemcitabine plus cisplatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Outcome
Type Measure Description Time frame Safety issue
Primary Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin
Secondary Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered Predetermined timepoints after dose administration
Secondary Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin
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