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Also known as BSI-201 (iniparib), BSI-201
bsi-201+ topotecan · 6 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| BSI-201 | EXPERIMENTAL | BSI-201 in combination with gemcitabine and carboplatin. |
| Pacitaxel/Carboplatin/Iniparib | EXPERIMENTAL | Participants will be administered pacitaxel, carboplatin and BSI-201 (Iniparib) in 21 day treatment cycles. Treatment will continue until disease progression or adverse effects prohibit further therapy. |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | BSI-201 + temozolomide |
| 3 | EXPERIMENTAL | bsi-201 + gemcitabine |
| 4 | EXPERIMENTAL | bsi-201 + carboplatin/paclitaxel |
| Iniparib | EXPERIMENTAL | - |
| Iniparib/irinotecan | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BSI-201 | DRUG | IV infusion, 5.6 mg/kg |
| paclitaxel | DRUG | Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days. |
| carboplatin | DRUG | Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days. |
| BSI-201 (Iniparib) | DRUG | BSI-201 will be administered IV over one hour twice weekly beginning on day 1 (doses of BSI-201 must be separated by at least 2 days). |
| bsi-201 plus temozolomide | DRUG | BSI-201 given iv. 2x weekly, temozolomide given orally |
| bsi-201 + topotecan | DRUG | 21 day cycle |
| bsi-201 + temozolomide | DRUG | 28 day cycle |
| bsi-201 + gemcitabine | DRUG | 28 day cycle |
| bsi-201 + carboplatin/paclitaxel | DRUG | 21 day cycle |
| irinotecan | DRUG | Irinotecan administered weekly, IV. |
Inclusion Criteria: * 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-se...
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BSI-201 plus topotecan is an investigational oncology combination built around BSI-201, also known as iniparib, a small molecule PARP1 inhibitor. It has been studied in solid tumors including glioblastoma, ovarian cancer, and uterine carcinosarcoma. The combination remains in clinical development and is not an approved therapy.
BSI-201 targets PARP1, an enzyme involved in DNA repair. By inhibiting PARP1, the agent is designed to interfere with tumor cell DNA damage repair. In the studied regimens it has been given alongside chemotherapy agents such as carboplatin, gemcitabine, paclitaxel, and topotecan in solid tumor settings.
BSI-201 is developed by Sanofi, which trades under the ticker SNY. Sanofi has sponsored and supported clinical evaluation of the PARP1 inhibitor both as a single agent and in chemotherapy combinations across several tumor types, including ovarian cancer, glioblastoma, and uterine carcinosarcoma.
BSI-201 is in Phase 1 development overall, with the studied combination regimens reaching Phase 2 in some trials. It is investigational and has not been approved for any indication. Reported trials are completed, and no active studies of BSI-201 are currently listed.
Completed studies include NCT00687765, a Phase 1 trial of BSI-201 in newly diagnosed malignant glioma with 126 patients, and NCT00687687, a Phase 2 trial in uterine carcinosarcoma. Two Phase 2 ovarian cancer studies, NCT01033292 and NCT01033123, evaluated carboplatin and gemcitabine with BSI-201.
Yes, BSI-201 is also known as iniparib. Published trial titles and registry records use both names for the same small molecule PARP1 inhibitor. Related naming variants include BSI-201 plus topotecan and BSI-201 plus temozolomide, which refer to specific chemotherapy combinations rather than separate drugs.