MedDataX Logo

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

NCT ID: NCT00243347

Last Updated: 2013-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

RECENTIN

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2171

oral tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cediranib RECENTIN™

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca Oncology Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Houston, Texas, United States

Site Status

Research Site

Barcelona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D8480C00015

Identifier Type: -

Identifier Source: org_study_id