Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: AZD2171; Drug: AZD0530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475956

D8480C00014

EuDract #2006-003505-55

Details and patient eligibility

About

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written consent
• Cancer diagnosis & stage
• Patients for whom no standard therapy exists
• World Health Organization (WHO) performance status 0-2
• One or more measurable lesions

Exclusion criteria

• Prostate cancer
• Untreated unstable brain or meningeal metastases
• Specific laboratory ranges
• Pregnant or breast-feeding women
• Any evidence of severe or uncontrolled diseases
• Participation in other trials within 30 days

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

1

Experimental group

Description:

AZD2171 Monotherapy

Treatment:

Drug: AZD2171

2

Experimental group

Description:

AZD2171 + AZD0530

Treatment:

Drug: AZD0530

Drug: AZD2171