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

Advanced Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502060
• Other study ID #: D8480C00004
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: May 13, 2009
• Start date: August 2004
• Est. completion date: June 2006

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Tumor

Intervention

Drug:
• AZD2171

• ZD1839

Locations

Country	Name	City	State
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days