Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases

A Phase I Single Centre 2-part Open Study to Assess the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignant Tumors and Liver Metastases

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00501605

Enrollment

Registered

2007-07-16

Start date

2003-02-28

Completion date

2006-02-28

Last updated

2011-01-21

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

Conditions

Advanced Solid Tumor, Liver Metastases

Keywords

Phase I, AZD2171, advanced solid tumors

Brief summary

Single centre recruiting approximately 80 patients who are given a rising single, followed by multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in patients with solid tumors and metastatic liver disease.

Interventions

DRUGAZD2171

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Provision of written informed consent * Male/female, 18 yr or over * WHO status 0-2 * Refractory advanced solid tumor

Exclusion criteria

* Radiotherapy within 4 weeks of starting AZD2171 treatment * Low haemoglobin level * Low platelet or neutrophil counts

Design outcomes

Primary

Measure	Time frame
primary objective is to evaluate the safety and tolerability of ascending single&multiple oral doses of AZD2171 by assessment of AEs,BP,HR,RR,ECG,clinical chemistry,haematology,urinalysis incl 24hr collection for protein&creatinine and physical exam.	—

Secondary

Measure	Time frame
PK,assess the effects of AZD2171 on surrogate markets of activity and to make a preliminary assessment of anti-tumor activity by measurement of tumor response and time to progression	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026