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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00710268

Enrollment

Registered

2008-07-04

Start date

2008-06-30

Completion date

2009-11-30

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm Metastasis

Keywords

Bevacizumab, Poly(ADP ribose) polymerases, Metastatic Solid Tumours, PARP inhibitor

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.

Interventions

DRUGAZD2281

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

DRUGBevacizumab

IV administration10 mg/kg every 14 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026