Study to Assess Safety & Tolerability of AZD2281 in Combination With Bevacizumab in Patients With Advanced Solid Tumours

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Neoplasm Metastasis

Treatments: Drug: Bevacizumab; Drug: AZD2281

Study type: Interventional

Funder types: Industry

Identifiers

NCT00710268

D0810C00022

Details and patient eligibility

About

Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with AZD2281 when administered in combination with Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
• Adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol
• Estimated life expectancy of at least 12 weeks

Exclusion criteria

• Disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event
• Hypertension (high blood pressure) or significant cardiovascular disease
• Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Experimental group

Description:

Dose Escalation Study 50, 100, 200, 400 mg

Treatment:

Drug: AZD2281

Drug: Bevacizumab