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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 30, 2008
Last updated: January 13, 2015
Last verified: January 2015
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 Intervention Phase
Neoplasm Metastasis
Drug: AZD2281
Drug: Bevacizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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 [ Time Frame: various timepoints. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters [ Time Frame: various timepoints. ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Olaparib
Drug: Bevacizumab
IV administration10 mg/kg every 14 days
Other Name: Avastin


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00710268

United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
Study Director: James Carmichael, BSc MBChB MD FRCP KuDOS Pharmaceuticals Ltd
Principal Investigator: Malcolm Ranson Christie Hospital, Manchester, UK
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00710268     History of Changes
Other Study ID Numbers: D0810C00022 
Study First Received: June 30, 2008
Last Updated: January 13, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Poly(ADP ribose) polymerases
Metastatic Solid Tumours
PARP inhibitor

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 05, 2016