A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Pemetrexed; Drug: FOLFOX; Drug: Docetaxel; Drug: Irinotecan (administered with & without Cetuximab); Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502567

D8480C00008

Details and patient eligibility

About

A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
• measurable lesion by CT or other techniques according to RECIST

Exclusion criteria

• Inadequate bone marrow reserve
• history of poorly controlled hypertension

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)