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

NCT ID: NCT00243347

Last Updated: 2013-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-07-31

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.

Conditions

Carcinoma; Non-Small-Cell Lung Carcinoma; Head and Neck Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AZD2171

oral tablet

Intervention Type: DRUG

Other Intervention Names

cediranib; RECENTIN™

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AstraZeneca Oncology Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Houston, Texas, United States

Research Site

Barcelona, , Spain

Countries

United States; Spain

Other Identifiers

D8480C00015

Identifier Type: -

Identifier Source: org_study_id