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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Dose Escalation Study 50, 100, 200, 400 mg

Group Type EXPERIMENTAL

AZD2281

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

IV administration10 mg/kg every 14 days

Interventions

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AZD2281

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

Intervention Type DRUG

Bevacizumab

IV administration10 mg/kg every 14 days

Intervention Type DRUG

Other Intervention Names

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Olaparib Avastin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No