NCT00502060

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
Last Updated

May 14, 2009

Status Verified

May 1, 2009

Enrollment Period

1.8 years

First QC Date

July 13, 2007

Last Update Submit

May 13, 2009

Conditions

Advanced Tumor

Keywords

Phase IAZD2171ZD1839solid tumor

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days

Interventions

AZD2171DRUG
ZD1839DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tumor progressed on standard therapy or ineligible for standard therapy
  • life expectancy of 12 weeks or more
  • WHO performance status 0-2

You may not qualify if:

  • History of active interstitial lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Amsterdam, Netherlands

Location

Research Site

Nijmegen, Netherlands

Location

Research Site

Utrecht, Netherlands

Location

MeSH Terms

Interventions

cediranibGefitinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nick Botwood, BSc, MBBS, MRCP, MFPM

    AstraZeneca

    STUDY DIRECTOR

  • G Giaccone, Prof

    Vrije Universiteit Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 17, 2007

Study Start

August 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

May 14, 2009

Record last verified: 2009-05

Locations

NL(3)