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

AstraZeneca80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor Liver Metastases

Interventions

AZD2171DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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