Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00502060
• Collaborator: (none)
• Enrollment: 65
• Locations: 3
• Duration (Months): 22
• Patients Per Site: 21.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer

Condition or Disease	Intervention/Treatment	Phase
Advanced Tumor	Drug: AZD2171; Drug: ZD1839	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 65 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Open-Label Study to Assess the Safety, Tolerability and PK of Ascending Multiple Oral Doses of AZD2171 When co-Administered With Fixed Multiple Oral Doses of ZD1839 (250mg or 500mg Once Daily) in Patients With Advanced Cancer
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839 []

Secondary Outcome Measures

1. to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• tumor progressed on standard therapy or ineligible for standard therapy

• life expectancy of 12 weeks or more

• WHO performance status 0-2

Exclusion Criteria:

• History of active interstitial lung disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Amsterdam		Netherlands
2	Research Site	Nijmegen		Netherlands
3	Research Site	Utrecht		Netherlands

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
• Principal Investigator: G Giaccone, Prof, Vrije Universiteit Medical Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00502060
• Other Study ID Numbers: D8480C00004
• First Posted: Jul 17, 2007
• Last Update Posted: May 14, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: Phase I; AZD2171; ZD1839; solid tumor
• Additional relevant MeSH terms: Cediranib; Gefitinib

Study Results

No Results Posted as of May 14, 2009