Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Iniparib (SAR240550 - BSI-201), Iniparib (SAR2405550 -BSI-201), SAR240550, BSI-201
Iniparib · 9 trials · 13 indications
AS measured by intra or extra cranial time to progression (TTP)
Proportion of participants with confirmed complete response (CR) or partial response (PR) as confirmed by an Independent Radiology Review Committee (IRRC) based on central review of scans in a blinded manner.
Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions: * Drug: Iniparib monotherapy * Drug: Iniparib + gemcitabine + carboplatin * Drug: Iniparib + topotecan * Drug: Iniparib + irinotecan * Drug: Iniparib + paclitaxel * Drug: Iniparib + liposomal doxorubicin + carboplatin |
| SAR240550 twice weekly/ paclitaxel weekly | EXPERIMENTAL | SAR240550 will be administered at the dose of 5.6mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions twice weekly (day 1 and day 4; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). |
| SAR240550 weekly/ paclitaxel weekly | EXPERIMENTAL | SAR240550 will be administered at the dose of 11.2 mg/kg as a 60-min intravenous (IV) infusion. Patients will receive SAR240550 infusions once weekly (day 1; total dose of 11.2mg/kg per week) and paclitaxel weekly as a 60-min IV infusion (day 1; dose of 80mg/m2). |
| Paclitaxel alone | ACTIVE_COMPARATOR | Paclitaxel will be administered at the dose of 80mg/m2 as a 60-min IV infusion. Patients will receive weekly (day 1) paclitaxel infusions. |
| INIPARIB, irinotecan | EXPERIMENTAL | - |
| Iniparib/ Gemcitabine/ Cisplatin | EXPERIMENTAL | Iniparib, 5.6 mg/kg, 60-min IV infusion twice weekly (days 1, 4, 8, and 11). Infusion starts after completion of GC regimen administration. Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. |
| Gemcitabine/ Cisplatin | ACTIVE_COMPARATOR | Gemcitabine, 1250 mg/m2, 30-min IV infusion on day 1 and day 8 and cisplatin 75mg/m², 3- to 4-hour IV infusion on day 1 of each 3-week cycle after the end of gemcitabine infusion. |
| Gencitabine + iniparib twice weekly | EXPERIMENTAL | Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 5.6 mg/kg IV over 60 minutes on Days 1, 4, 8 and 11 of 3-week cycles |
| Gencitabine + iniparib weekly | EXPERIMENTAL | Gemcitabine, 1000 mg/m² IV over 30 minutes and carboplatin, area under the curve (AUC) = 2, IV over 60 minutes, both on Days 1 and 8 of 3-week cycles. Iniparib, 11.2 mg/kg IV over 60 minutes on Days 1 and 8 of 3-week cycles |
| Iniparib | EXPERIMENTAL | Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles |
| Iniparib, single agent | EXPERIMENTAL | Iniparib will be initially administered intravenously once weekly (days 1, 8, and 15) for 3 weeks, in a 21-day cycle. Then, iniparib will be administered twice weekly (days 1, 4, 8, 11, 15, and 18) in a 21-day cycle. Cycle1 (day 1 thru day 21) will be defined as the dose limiting toxicities (DLT) observation period. Starting dose is 15 mg/kg once weekly. |
| Iniparib/Gemcitibine/Carboplatin | EXPERIMENTAL | Gemcitabine/carboplatin (GC) : Gemcitabine will be administered at 1,000 mg/m² as a 30min IV infusion and carboplatin area under the curve (AUC) 2 as a 60min IV infusion. Patients will receive gemcitabine/carboplatin infusions once weekly (days 1 and 8). Iniparib will be administered for two weeks, followed by a 1week of rest in a 21-day cycle (weekly schedule: days 1 and 8; twice weekly schedule: days: 1, 4, 8 and 11). |
| Iniparib/Paclitaxel | EXPERIMENTAL | Paclitaxel (P): Paclitaxel will be administered at the dose of 80 mg/m2 as a 60-minute intravenous infusion administered on days 1, 8, and 15 followed by a 1week of rest. Iniparib will be administered for three weeks, followed by 1week of rest in a 28-day cycle (weekly schedule: days 1, 8 and 15; twice weekly schedule: days 1, 4, 8, 11, 15 and 18). |
| Iniparib/Pegylated liposomal doxorubicin/Carboplatin | EXPERIMENTAL | Pegylated liposomal doxorubicin (Doxil)/Carboplatin (PLD) : Doxil will be administered at 30 mg/m² as a 30min IV infusion and carboplatin AUC 4 as a 60min IV infusion on day 1 every four weeks. Iniparib will be administered for two weeks in a 28-day cycle (weekly schedule: days 1, and 8; twice weekly schedule: days 1, 4, 8, and 11). |
| SAR240550 | EXPERIMENTAL | * single cohort: SAR240550 * combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin |
| Name | Type | Description |
|---|---|---|
| Iniparib (SAR240550/BSI-201) | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Carboplatin | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Doxorubicin HCL liposome injection | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Gemcitabine | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Irinotecan | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Paclitaxel | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Topotecan | DRUG | Pharmaceutical form:Solution Route of administration: Intravenous |
| Iniparib (SAR2405550 -BSI-201) | DRUG | Pharmaceutical form : solution for infusion Route of administration :Intravenous |
| INIPARIB + irinotecan | DRUG | 21 day cycle |
| Iniparib | DRUG | Pharmaceutical form: solution for infusion Route of administration: 60-minute IV infusion |
| cisplatin | DRUG | Pharmaceutical form: solution for infusion Route of administration: 1- to 4-hour IV infusion, according to the local standard |
| Iniparib (SAR240550-BSI-201) | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| Placlitaxel | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| Pegylated liposomal doxorubicin | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| Iniparib (SAR240550 - BSI-201) | DRUG | Pharmaceutical form:sterile aqueous solution Route of administration: intravenous |
Inclusion criteria : * Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen. * Previously received and are continuing to derive clin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Iniparib is an investigational small molecule oncology drug developed by Sanofi for the treatment of solid tumors and breast cancer. It has been studied in advanced solid tumors, malignant neoplasms, and estrogen receptor negative breast cancer. Iniparib is not approved and remains in clinical development.
Iniparib belongs to the -parib (PARP) target class, indicating it is designed to target poly (ADP-ribose) polymerase. PARP inhibition is an established mechanism in oncology drug development. Iniparib is a small molecule agent in this class.
Iniparib is developed by Sanofi, which trades under the ticker SNY. Sanofi has sponsored clinical trials of the drug in solid tumors and breast cancer. The compound is also known by the code names SAR240550 and BSI-201.
Iniparib is in Phase 1 development. It is an investigational drug and has not been approved by the FDA. Clinical testing has included Phase 1, Phase 2, and Phase 3 studies, but the drug remains in clinical development.
Iniparib has been studied in several completed trials, including NCT01593228, a Phase 3 treatment extension study in solid tumors; NCT01455532, a Phase 1 dose escalation study in malignant neoplasms; NCT01213381, a Phase 1 study in advanced solid tumors in Japan; and NCT01204125, a Phase 2 study in triple negative breast cancer.
Yes, Iniparib is also known as SAR240550 and BSI-201. These are alternative names and code designations for the same investigational compound. It has also been referred to in combination regimens as Iniparib plus irinotecan.