Breast CancerPhase 1NCT00707707
Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
A Phase 1 study testing AZD2281 and Paclitaxel in people with Breast Cancer and Triple Negative Breast Cancer, run by AstraZeneca at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- AZD2281 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 15 Sep 2008to 19 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Australia3 sites
Research Site
Auchenflower, 4066
Research Site
Parkville, 3050
Research Site
Perth, 6000
About this study
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.
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.
- Being tested
- AZD2281, Paclitaxel
- Keywords
- breast cancer, triple negative, metastatic
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2281Drug
Also called Olaparib
Dose finding study to establish the appropriate dose of AZD2281
PaclitaxelDrug
Also called Taxol
Intravenous infusion over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | paclitaxel + AZD2281 Receives: Drug: AZD2281; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis
Measured: Physical examination/ ECG approximately monthly.Adverse Events, Vital signs, Haematology/ clinical chemistry, Urinalysis weekly throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study start15 Sep 2008
- Primary completion9 Nov 2009
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Dent, MD, Principal investigator, Sunnybrook Health Sciences Centre, TorontoMark Clemons, MD, Principal investigator, Princess Margaret Hospital, TorontoMika Sovak, MD PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707707
- Sponsor's protocol ID
- D0810C00011
- Status last verified
- Feb 2018
- First submitted
- 27 Jun 2008
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24063698
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00707707
- Acronym / sponsor ID
- D0810C00011
- Keywords
- breast cancer, triple negative, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2008 (actual)
- Primary completion
- 9 Nov 2009 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 1 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2281, Drug: Paclitaxelpaclitaxel + AZD2281 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD2281Also: OlaparibDose finding study to establish the appropriate dose of AZD2281 | Drug | 1 |
| PaclitaxelAlso: TaxolIntravenous infusion over 1 hour | Drug | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 24063698Dent 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.
- D0810C00011\_CSR\_SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Dent, MD principal investigator
Sunnybrook Health Sciences Centre, Toronto
Mark Clemons, MD principal investigator
Princess Margaret Hospital, Toronto
Mika Sovak, MD PhD study director
AstraZeneca
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2281 and Paclitaxel in people with Breast Cancer and Triple Negative Breast Cancer, run by AstraZeneca at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Austria, Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.