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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00710268

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis	Drug: AZD2281 Drug: Bevacizumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I, Open Label, Dual Centre Study To Assess The Safety And Tolerability Of AZD2281 In Combination With Bevacizumab (Avastin®) In Patients With Advanced Solid Tumours

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dose Escalation Study 50, 100, 200, 400 mg	Drug: AZD2281 Oral Capsule, Dose Escalation 50, 100, 200, 400 mgContinuous twice daily dosing Other Names: Olaparib Drug: Bevacizumab IV administration10 mg/kg every 14 days Other Names: Avastin

Arm

Intervention/Treatment

Experimental: 1

Dose Escalation Study 50, 100, 200, 400 mg

Drug: AZD2281

Oral Capsule, Dose Escalation 50, 100, 200, 400 mgContinuous twice daily dosing

Other Names:

Olaparib

Drug: Bevacizumab

IV administration10 mg/kg every 14 days

Other Names:

Avastin

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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