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

Study Overview
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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.

Official Title
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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

Conditions
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Neoplasm Metastasis

Intervention / Treatment
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* Drug: AZD2281
* Drug: Bevacizumab


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose Escalation Study 50, 100, 200, 400 mg | Drug: AZD2281<br>* Oral Capsule, Dose Escalation 50, 100, 200, 400 mgContinuous twice daily dosing<br>* Other names: Olaparib;Drug: Bevacizumab<br>* IV administration10 mg/kg every 14 days<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters |  | various timepoints. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bevacizumab, Poly(ADP ribose) polymerases, Metastatic Solid Tumours, PARP inhibitor