The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:

An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243347
• Other study ID #: D8480C00015
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2005
• Last updated: August 9, 2013
• Start date: December 2005
• Est. completion date: July 2009

Study information

• Verified date: August 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC)

• At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan

• Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease

• Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease

Exclusion Criteria:

• NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171

• HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171

• Untreatable, unstable brain or meningeal metastases.

• Abnormal liver and kidney blood chemistries

• History of poorly controlled hypertension with resting blood pressure of >150/100

• Recent (< 14 days) major surgery or a surgical incision not fully healed

• Diabetes patients with type I insulin dependent diabetes or poorly controlled type II

• Significant hemorrhage or hemoptysis

• Presence of necrotic/hemorrhagic tumor or metastases

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Head and Neck Neoplasms
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• AZD2171
oral tablet

Locations

Country	Name	City	State
Spain	Research Site	Barcelona
United States	Research Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)	Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100	Randomisation until Day 22	No
Secondary	Change From Baseline in Mean Arterial Blood Pressure (MAP)	Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).	Randomisation until Day 22	No

External Links

•   AstraZeneca Information - Outside of the US
•   US and Canada only