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

Phase 1

Completed

• Conditions: Neoplasm Metastasis
• Interventions: Drug: AZD2281; Drug: Bevacizumab

• Registration Number: NCT00710268
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-03
• Study Completion: 2009-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bevacizumab	Dose Escalation Study 50, 100, 200, 400 mg
1	AZD2281	Dose Escalation Study 50, 100, 200, 400 mg

Primary Outcome Measures

Name	Time	Method
safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with Bevacizumab to patients with advanced solid tumours by assessment of adverse events, vital signs, ECG, clinical chem, haematology, urinalysis and phys exam	various timepoints.

Secondary Outcome Measures

Name	Time	Method
To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters	various timepoints.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Oxford, United Kingdom