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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Tumor
Both
Advanced Tumor
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
Nick Botwood, BSc, MBBS, MRCP, MFPM
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
Study ID:
D8480C00004
NCT ID:
NCT00502060
Start Date:
August 2004
Completion Date:
June 2006
Related Keywords:
- Advanced Tumor
- Phase I
- AZD2171
- ZD1839
- solid tumor
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