Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bsi-201 plus temozolomide · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| bsi-201 plus temozolomide | DRUG | BSI-201 given iv. 2x weekly, temozolomide given orally |
Inclusion Criteria: 1. Patients must be at least 18 years of age 2. Patients must have a Karnofsky performance status \> 60% (i.e. the patient must be able to care for himself/herself with occasional help from others) 3. Patients must have the following hematologic, renal and liver function (i.e. A...
BSI-201 is an investigational small molecule being studied for use in oncology, specifically in glioblastoma, ovarian cancer, uterine carcinosarcoma, and other tumors. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.
BSI-201 is a poly (ADP-ribose) polymerase-1 (PARP-1) inhibitor, as indicated in the clinical trial title. It targets the PARP-1 enzyme, which is involved in DNA repair, making it a potential therapeutic approach for certain cancers.
BSI-201 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is responsible for the clinical development and potential commercialization of this investigational drug.
BSI-201 has completed Phase 1 and Phase 2 clinical trials. The most advanced studies were Phase 2, including a trial in platinum-resistant recurrent ovarian cancer. However, it is not approved and remains an investigational agent in clinical development.
BSI-201 has been studied in several completed trials, including NCT00298675, a Phase 1 dose escalation study in advanced solid tumors; NCT00422682, a Phase 1 combination study; NCT00687765, a Phase 1 study in malignant glioma; and NCT01033292, a Phase 2 study in ovarian cancer.
BSI-201 is also known as iniparib, a name that has been used in clinical research. It is a PARP-1 inhibitor that has been investigated for various cancers, including glioblastoma and ovarian cancer, though it is not approved.