Ovarian CancerPhase 2NCT01033123
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
A Phase 2 study testing BSI-201 in people with Ovarian Cancer, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-sensitive recurrent ovarian cancer patients receiving gemcitabine and carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- BSI-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 2012
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma
- Completion of only one previous course of chemotherapy which contained a platinum therapy, with sensitivity to that regimen. "Platinum-sensitivity" is defined by a relapse greater than 6 months after termination of platinum-based chemotherapy
- Measurable disease, defined by at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded), and is ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, computed tomography [CT], or magnetic resonance imaging [MRI]) or ≥ 10 mm when measured by spiral CT
- Adequate organ function defined as: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, creatinine clearance > 50mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN; or < 5 x ULN in case of liver metastases); total bilirubin < 1.5 mg/dL
- For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control during the duration of the study therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Signed, institutional review board (IRB) approved written informed consent
Who cannot join
- Concurrent invasive malignancy, not including:
- Non-melanomatous skin cancer
- In situ malignancies
- Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium)
- Low risk breast cancer (localized, non-inflammatory) treated with curative intent
- Lesions identifiable only by positron emission tomography (PET)
Show all 14Show fewer
- Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including BSI-201
- Major medical conditions that might affect study participation (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection)
- Other significant co-morbid condition which the investigator feels might compromise effective and safe participation in the study, including a history of congestive cardiac failure or an electrocardiogram (ECG) suggesting significant conduction defect or myocardial ischemia
- Enrollment in another investigational device or drug study, or current treatment with other investigational agents
- Concurrent radiation therapy to treat primary disease throughout the course of the study
- Inability to comply with the requirements of the study
- Pregnancy or lactation
- Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Ceneral Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-sensitive recurrent ovarian cancer patients receiving gemcitabine and carboplatin.
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
- Ovarian Cancer
- Being tested
- BSI-201
- Keywords
- ovarian, cancer, sensitive, PARP, recurrent, platinum-sensitive recurrent ovarian cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms, Hypersensitivity, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSI-201Drug
Also called PARP inhibitor
IV infusion, 5.6 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| BSI-201 | Experimental | BSI-201 in combination with gemcitabine and carboplatin. Receives: Drug: BSI-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201
Measured: Until progressive disease or death
Secondary outcomes (2)
To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201
Measured: 30 days after last BSI-201 exposure
To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201
Measured: until progressive disease or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2012
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 Ovarian 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033123
- Sponsor's protocol ID
- TCD11503
- Other IDs
- 20090207
- Status last verified
- Feb 2016
- First submitted
- 14 Dec 2009
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Penson RT, Ambrosio AJ, Whalen CA, Krasner CN, Konstantinopoulos PA, Bradley C, Matulonis UA, Birrer MJ. Phase II Trials of Iniparib (BSI-201) in Combination with Gemcitabine and Carboplatin in Patients with Recurrent Ovarian Cancer. Oncologist. 2023 Mar 17;28(3):252-257. doi: 10.1093/oncolo/oyac275.
PubMed 36718018
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 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01033123
- Acronym / sponsor ID
- TCD11503
- Conditions
- Ovarian Cancer
- Keywords
- ovarian, cancer, sensitive, PARP, recurrent, platinum-sensitive recurrent ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Dec 2009 (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 this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-sensitive recurrent ovarian cancer patients receiving gemcitabine and carboplatin.
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 |
|---|---|---|
| BSI-201 | Experimental | Drug: BSI-201BSI-201 in combination with gemcitabine and carboplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma
- Completion of only one previous course of chemotherapy which contained a platinum therapy, with sensitivity to that regimen. "Platinum-sensitivity" is defined by a relapse greater than 6 months after termination of platinum-based chemotherapy
- Measurable disease, defined by at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded), and is ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, computed tomography [CT], or magnetic resonance imaging [MRI]) or ≥ 10 mm when measured by spiral CT
- Adequate organ function defined as: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, creatinine clearance > 50mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN; or < 5 x ULN in case of liver metastases); total bilirubin < 1.5 mg/dL
Key exclusion criteria (14 listed)
- Concurrent invasive malignancy, not including:
- Lesions identifiable only by positron emission tomography (PET)
- Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including BSI-201
- Major medical conditions that might affect study participation (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection)
- Other significant co-morbid condition which the investigator feels might compromise effective and safe participation in the study, including a history of congestive cardiac failure or an electrocardiogram (ECG) suggesting significant conduction defect or myocardial ischemia
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 |
|---|---|---|
| BSI-201Also: PARP inhibitorIV infusion, 5.6 mg/kg | Drug | BSI-201 |
Primary outcome
To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201
Time frame: Until progressive disease or death
2 secondary outcomes
To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201
Time frame: 30 days after last BSI-201 exposure
To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201
Time frame: until progressive disease or death
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.
- Derived from this study: PubMed 36718018Penson RT, Ambrosio AJ, Whalen CA, Krasner CN, Konstantinopoulos PA, Bradley C, Matulonis UA, Birrer MJ. Phase II Trials of Iniparib (BSI-201) in Combination with Gemcitabine and Carboplatin in Patients with Recurrent Ovarian Cancer. Oncologist. 2023 Mar 17;28(3):252-257. doi: 10.1093/oncolo/oyac275.
Related trials for Ovarian Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingObservational study
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Ovarian Cancer, BRCA Mutation
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BSI-201 in people with Ovarian Cancer, run by Sanofi at 1 site 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 14 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 1 site 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?
To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201 (time frame: Until progressive disease or death). 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 NCT01033123, 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 17 Mar 2016.