Estrogen Receptor Negative (ER-Negative) Breast CancerPhase 2NCT01173497
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
A Phase 2 study testing INIPARIB + irinotecan in people with Estrogen Receptor Negative (ER-Negative) Breast Cancer and Progesterone Receptor Negative (PR-Negative) Breast Cancer, run by Sanofi at 13 sites in United States.
Trial summary
The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer, Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer
- What is being tested?
- INIPARIB + irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2010to Jul 2013
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
- ECOG Performance Status of 0-2.
- Life expectancy of >12 weeks.
- No limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤Grade 1 or baseline.
- No active serious infection or other comorbid illness which would impair ability to participate in the trial.
- Stable or decreasing dose of steroids for ≥ 7 days.
- Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
- Patients must have adequate organ function.
Who cannot join
- Pregnant or breast-feeding
- Prior allergic reaction to INIPARIB
- Prior allergic reaction to irinotecan.
- Evidence of hemorrhage or impending herniation on baseline brain imaging
- Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
- Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
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- Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
- Contraindication to gadolinium-enhanced MRI imaging.
- Inability to comply with study and/or follow-up procedures.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan
Ann Arbor, Michigan
Johns Hopkins University
Baltimore, Maryland
University of Alabama At Birmingham
Birmingham, Alabama
Dana Farber Cancer Institute
Boston, Massachusetts
University of North Carolina-CH Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599-7295
University of Chicago
Chicago, Illinois
Duke University
Durham, North Carolina
MD Anderson Cancer Center
Houston, Texas
Indiana University Simon Cancer Center
Indianapolis, Indiana
Vanderbilt University
Nashville, Tennessee
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
University of California At San Francisco
San Francisco, California
Georgetown University
Washington D.C., District of Columbia
About this study
Official title: A Phase II Study of the PARP Inhibitor, INIPARIB (BSI-201), in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
- Conditions
- Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer, Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer, Brain Metastases
- Being tested
- INIPARIB + irinotecan
- Keywords
- Triple negative breast cancer, Brain metastasis, BSI-201, iniparib
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INIPARIB + irinotecanDrug
21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| INIPARIB, irinotecan | Experimental | Not described Receives: Drug: INIPARIB + irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
AS measured by intra or extra cranial time to progression (TTP)
Measured: 12 months
Secondary outcomes (1)
Response Rate
as measured by RECIST
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor Negative (ER-Negative) Breast CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UNC Lineberger Comprehensive Cancer Center
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173497
- Sponsor's protocol ID
- TCD11608
- Other IDs
- 20100210
- Status last verified
- Feb 2016
- First submitted
- 28 Jul 2010
- Last updated
- 17 Mar 2016
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the PARP Inhibitor, INIPARIB (BSI-201), in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
- ClinicalTrials.gov ID
- NCT01173497
- Acronym / sponsor ID
- TCD11608
- Conditions
- Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer, Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer, Brain Metastases
- Keywords
- Triple negative breast cancer, Brain metastasis, BSI-201, iniparib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- UNC Lineberger Comprehensive Cancer Center
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Aug 2010 (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.
The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INIPARIB, irinotecan | Experimental | Drug: INIPARIB + irinotecan |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
- ECOG Performance Status of 0-2.
- Life expectancy of >12 weeks.
- No limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤Grade 1 or baseline.
- No active serious infection or other comorbid illness which would impair ability to participate in the trial.
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding
- Prior allergic reaction to INIPARIB
- Prior allergic reaction to irinotecan.
- Evidence of hemorrhage or impending herniation on baseline brain imaging
- Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
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 |
|---|---|---|
| INIPARIB + irinotecan21 day cycle | Drug | INIPARIB, irinotecan |
Primary outcome
Efficacy
Time frame: 12 months
AS measured by intra or extra cranial time to progression (TTP)
1 secondary outcome
Response Rate
Time frame: 12 months
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 17 Mar 2016.
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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.
Clinical Sciences & Operations study director
Sanofi
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INIPARIB + irinotecan in people with Estrogen Receptor Negative (ER-Negative) Breast Cancer and Progesterone Receptor Negative (PR-Negative) Breast Cancer, run by Sanofi at 13 sites in United States.
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 8 inclusion and 9 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2016.