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

June 30, 2008
December 9, 2010
June 2008
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00710268 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm Metastasis
  • 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
Experimental: 1
Dose Escalation Study 50, 100, 200, 400 mg
Interventions:
  • Drug: AZD2281
  • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00710268
D0810C00022
Yes
Jim Carmichael - Medical Science Director, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: James Carmichael, BSc MBChB MD FRCP KuDOS Pharmaceuticals Ltd
Principal Investigator: Malcolm Ranson Christie Hospital, Manchester, UK
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP