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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502060

Enrollment

Registered

2007-07-17

Start date

2004-08-31

Completion date

2006-06-30

Last updated

2009-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Tumor

Keywords

Phase I, AZD2171, ZD1839, solid tumor

Brief summary

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

Interventions

DRUGAZD2171

DRUGZD1839

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026