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

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ClinicalTrials.gov Identifier: NCT00710268
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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 Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


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 Name: Olaparib

Drug: Bevacizumab
IV administration10 mg/kg every 14 days
Other Name: Avastin




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters [ Time Frame: various timepoints. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710268


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00710268     History of Changes
Other Study ID Numbers: D0810C00022
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Bevacizumab
Olaparib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action