Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
March 5, 2018 updated by: AstraZeneca
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 130 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
paclitaxel + AZD2281
|
Dose finding study to establish the appropriate dose of AZD2281
Other Names:
Intravenous infusion over 1 hour
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca Dent, MD, Sunnybrook Health Sciences Centre, Toronto
- Principal Investigator: Mark Clemons, MD, Princess Margaret Hospital, Toronto
- Study Director: Mika Sovak, MD PhD, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2008
Primary Completion (Actual)
November 9, 2009
Study Completion (Actual)
February 19, 2018
Study Registration Dates
First Submitted
June 27, 2008
First Submitted That Met QC Criteria
June 27, 2008
First Posted (Estimate)
July 1, 2008
Study Record Updates
Last Update Posted (Actual)
March 6, 2018
Last Update Submitted That Met QC Criteria
March 5, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Poly(ADP-ribose) Polymerase Inhibitors
- Paclitaxel
- Olaparib
Other Study ID Numbers
- D0810C00011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.