search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD2171
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring RECENTIN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
October 21, 2005
Last Updated
August 9, 2013
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00243347
Brief Title
The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung Carcinoma, Head and Neck Neoplasms
Keywords
RECENTIN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AZD2171
Other Intervention Name(s)
cediranib, RECENTIN™
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)
Description
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
Time Frame
Randomisation until Day 22
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Arterial Blood Pressure (MAP)
Description
Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).
Time Frame
Randomisation until Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Oncology Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs