A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503477

D8480C00023

Details and patient eligibility

About

A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients

Enrollment: 40 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• advanced solid tumors
• life expectancy is 12 weeks or longer

Exclusion criteria

• patient with uncontrolled brain metastases
• patient with inappropriate laboratory test values
• patient with poorly controlled hypertension

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)