Back to resultsPhase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Primary Purpose
Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD2281
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, triple negative, metastatic
Eligibility Criteria
Inclusion Criteria:
- patients with histologically or cytologically diagnosed metastatic triple negative breast cancer (Oestrogen, progesterone and HER2 negative adenocarcinoma of the breast)
- Patients must have normal organ and bone marrow function, ECOG performance status of no more than 2
- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.
Exclusion Criteria:
- Any chemotherapy, radiotherapy (except for palliative reasons) or investigational product, within 2 weeks from the last dose prior to study entry (or longer period, depending on the agent used)
- Major surgery within 4 weeks of starting the study, and must have recovered from any effects of major surgery
- Patients requiring treatment with the following:certain antibiotic drugs, St.John's Wort, carbamazepine, phenobarbitone, phenytoin, and certain protease inhibitors/ non-nucleoside reverse transcriptase inhibitors used as components of HIV/AIDS treatment,
- Patients with second primary cancer; except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for at least 5 years.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
paclitaxel + AZD2281
Outcomes
Primary Outcome Measures
Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00707707
Brief Title
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Official Title
Phase I/II Randomised, Double- Blind, Multi-centre Study to Assess the Efficacy of AZD2281 When Given in Combination With Paclitaxel in the 1st or 2nd Line Treatment of Patients With Metastatic Triple Negative Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 15, 2008 (Actual)
Primary Completion Date
November 9, 2009 (Actual)
Study Completion Date
February 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer
Keywords
breast cancer, triple negative, metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
paclitaxel + AZD2281
Intervention Type
Drug
Intervention Name(s)
AZD2281
Other Intervention Name(s)
Olaparib
Intervention Description
Dose finding study to establish the appropriate dose of AZD2281
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Intravenous infusion over 1 hour
Primary Outcome Measure Information:
Title
Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis
Time Frame
Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with histologically or cytologically diagnosed metastatic triple negative breast cancer (Oestrogen, progesterone and HER2 negative adenocarcinoma of the breast)
Patients must have normal organ and bone marrow function, ECOG performance status of no more than 2
Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.
Exclusion Criteria:
Any chemotherapy, radiotherapy (except for palliative reasons) or investigational product, within 2 weeks from the last dose prior to study entry (or longer period, depending on the agent used)
Major surgery within 4 weeks of starting the study, and must have recovered from any effects of major surgery
Patients requiring treatment with the following:certain antibiotic drugs, St.John's Wort, carbamazepine, phenobarbitone, phenytoin, and certain protease inhibitors/ non-nucleoside reverse transcriptase inhibitors used as components of HIV/AIDS treatment,
Patients with second primary cancer; except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for at least 5 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Dent, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Clemons, MD
Organizational Affiliation
Princess Margaret Hospital, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mika Sovak, MD PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Research Site
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Research Site
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24063698
Citation
Dent RA, Lindeman GJ, Clemons M, Wildiers H, Chan A, McCarthy NJ, Singer CF, Lowe ES, Watkins CL, Carmichael J. Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first- or second-line treatment of patients with metastatic triple-negative breast cancer. Breast Cancer Res. 2013;15(5):R88. doi: 10.1186/bcr3484.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1673&filename=D0810C00011.pdf
Description
D0810C00011_CSR_Synopsis
Learn more about this trial
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
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