The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Stromal Tumors; Soft Tissue Sarcomas

Treatments: Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385203

D8480C00046

Details and patient eligibility

About

To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue Sarcoma (STS) resistant to standard therapy.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological confirmation of GIST which is resistant or intolerant to imatinib mesylate, or metastatic STS, which is refractory to standard therapies or for which no standard therapy exists

Exclusion criteria

• Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes.
• Patients with a history of poorly controlled high blood pressure

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)