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

Phase 1

Completed

• Conditions: Carcinoma; Non-Small-Cell Lung Carcinoma; Head and Neck Neoplasms

• Registration Number: NCT00243347
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-21
• Study First Submitted QC: 2005-10-21
• Study First Posted: 2005-10-24
• Study Start: 2005-12
• Primary Completion: 2008-05
• Study Completion: 2009-07
• Results First Submitted: 2013-03-22
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-09
• Last Update Submitted: 2013-08-09
• Results First Posted: 2013-10-17
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)	Randomisation until Day 22	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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Arterial Blood Pressure (MAP)	Randomisation until Day 22	Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).

Trial Locations

Locations (1)

Research Site; 🇪🇸 Barcelona, Spain