Back to resultsStudy to Assess Safety & Tolerability of AZD2281 in Combination With Bevacizumab in Patients With Advanced Solid Tumours
Primary Purpose
Neoplasm Metastasis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD2281
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Bevacizumab, Poly(ADP ribose) polymerases, Metastatic Solid Tumours, PARP inhibitor
Eligibility 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
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Dose Escalation Study 50, 100, 200, 400 mg
Outcomes
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
Secondary Outcome Measures
To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00710268
Brief Title
Study to Assess Safety & Tolerability of AZD2281 in Combination With Bevacizumab in Patients With Advanced Solid Tumours
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 Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
Bevacizumab, Poly(ADP ribose) polymerases, Metastatic Solid Tumours, PARP inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dose Escalation Study 50, 100, 200, 400 mg
Intervention Type
Drug
Intervention Name(s)
AZD2281
Other Intervention Name(s)
Olaparib
Intervention Description
Oral Capsule, Dose Escalation 50, 100, 200, 400 mgContinuous twice daily dosing
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
IV administration10 mg/kg every 14 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters
Time Frame
various timepoints.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Carmichael, BSc MBChB MD FRCP
Organizational Affiliation
KuDOS Pharmaceuticals Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Malcolm Ranson
Organizational Affiliation
Christie Hospital, Manchester, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1675&filename=D0810C00022.pdf
Description
D0810C00022_CSR_Synopsis
Learn more about this trial
Study to Assess Safety & Tolerability of AZD2281 in Combination With Bevacizumab in Patients With Advanced Solid Tumours
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