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BSI-201

Phase 2

Ovarian Cancer | Small molecule | Oncology |Sanofi|Last Updated: Mar 17, 2016

Success Probability

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

BSI-201 · 3 trials · 2 indications

Phase 2 3
NCT01033123A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian CancerOvarian Cancer
COMPLETED41 Analytics
NCT01033292A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian CancerOvarian Cancer
COMPLETED43 Analytics
NCT00687687Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine CarcinosarcomaUterine Carcinosarcoma
COMPLETED22 Analytics
PHASE2COMPLETED
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
Uterine CarcinosarcomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201
Until progressive disease or death
Clinical response rate
6 months

Secondary Endpoints

To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201
30 days after last BSI-201 exposure
To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201
until progressive disease or death
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BSI-201EXPERIMENTALBSI-201 in combination with gemcitabine and carboplatin.
Pacitaxel/Carboplatin/IniparibEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
BSI-201DRUGIV infusion, 5.6 mg/kg
paclitaxelDRUGPaclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
carboplatinDRUGCarboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
BSI-201 (Iniparib)DRUGBSI-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).
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about BSI-201

What is BSI-201 used for?

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.

What does BSI-201 target?

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.

Who makes BSI-201?

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.

What phase is BSI-201 in?

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.

What clinical trials is BSI-201 in?

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.

Is BSI-201 the same as iniparib?

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.