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bsi-201+ topotecan

Phase 1

Tumors | Small molecule | Oncology |Sanofi|Last Updated: Jun 10, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment195

FDA Designations

No designations recorded

Clinical trial landscape

bsi-201+ topotecan · 2 trials · 1 indication

Phase 1 2
NCT00422682A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid TumorsTumors
COMPLETED136 Analytics
NCT00298675Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid TumorsTumors
COMPLETED59 Analytics
PHASE1COMPLETED
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
TumorsUnlock trial analytics
PHASE1COMPLETED
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

safety and efficacy
ongoing
Response rate (CR + PR)
every 2 cycles
Maximum tolerated dose
After one cycle

Secondary Endpoints

Clinical Response
8 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBSI-201 + topotecan
2EXPERIMENTALBSI-201 + temozolomide
3EXPERIMENTALbsi-201 + gemcitabine
4EXPERIMENTALbsi-201 + carboplatin/paclitaxel
IniparibEXPERIMENTAL -
Iniparib/irinotecanEXPERIMENTAL -

Interventions

NameTypeDescription
bsi-201 + topotecanDRUG21 day cycle
bsi-201 + temozolomideDRUG28 day cycle
bsi-201 + gemcitabineDRUG28 day cycle
bsi-201 + carboplatin/paclitaxelDRUG21 day cycle
BSI-201 (iniparib)DRUGBSI-201 administered intravenously (IV), 2x weekly
irinotecanDRUGIrinotecan administered weekly, IV.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (without granulocyte colony-stimulating factor \[G-CSF\] support withi...

Countries:United States
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Frequently asked questions about bsi-201+ topotecan

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.