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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00710268
First received: June 30, 2008
Last updated: December 9, 2010
Last verified: December 2010
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jim Carmichael - Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00710268     History of Changes
Other Study ID Numbers: D0810C00022
Study First Received: June 30, 2008
Last Updated: December 9, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013