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

NCT00243347 | Completed Phase 1 Results

• 1 other identifier: D8480C00015
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 2

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

Keywords

RECENTIN

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change From Baseline in Mean Arterial Blood Pressure (MAP)

  Randomisation until Day 22

Interventions

AZD2171 DRUG

oral tablet

Also known as: cediranib, RECENTIN™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Houston, Texas, United States

Location

Research Site

Barcelona, Spain

Location

MeSH Terms

Conditions

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

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• AstraZeneca Oncology Medical Sciences Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 24, 2005
• Study Start: December 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2009
• Last Updated: October 17, 2013
• Results First Posted: October 17, 2013

Record last verified: 2013-08

Locations

ES (1); US (1)