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INIPARIB+ irinotecan

Phase 2

Estrogen Receptor Negative (ER-Negative) Breast Cancer | Small molecule | Oncology |Sanofi|Last Updated: Mar 17, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

INIPARIB+ irinotecan · 1 trial · 4 indications

Phase 2 1
NCT01173497A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain MetastasisEstrogen Receptor Negative (ER-Negative) Breast Cancer
COMPLETED44 Analytics
PHASE2COMPLETED
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
Estrogen Receptor Negative (ER-Negative) Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy
12 months

AS measured by intra or extra cranial time to progression (TTP)

Secondary Endpoints

Response Rate
12 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INIPARIB, irinotecanEXPERIMENTAL -

Interventions

NameTypeDescription
INIPARIB + irinotecanDRUG21 day cycle
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria - 1. Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging. 2. ECOG Performance Status of 0-2. 3. Life expectancy of \>12 weeks. 4. No limit to prior therapies with last anti-cancer treatment ≥ ...

Countries:United States
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Frequently asked questions about INIPARIB+ irinotecan

What is INIPARIB+ irinotecan used for?

INIPARIB+ irinotecan is an investigational oncology combination being studied for advanced solid tumors, breast cancer in females, malignant neoplasms, and primary peritoneal cancer. It is a small molecule therapeutic developed by Sanofi. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does INIPARIB+ irinotecan target?

INIPARIB is a PARP inhibitor, and when combined with irinotecan, a topoisomerase I inhibitor, the combination targets DNA repair pathways in cancer cells. This mechanism is being evaluated in clinical trials for various solid tumors and breast cancers. The combination is designed to exploit vulnerabilities in tumor cells' DNA damage response.

Who makes INIPARIB+ irinotecan?

INIPARIB+ irinotecan is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this combination therapy in oncology indications.

What phase is INIPARIB+ irinotecan in?

INIPARIB+ irinotecan is in Phase 2 clinical development. The drug is investigational and has not received FDA approval. Sanofi has completed two trials for this combination, with a total enrollment of 642 patients across studies in advanced solid tumors and breast cancer.

What clinical trials is INIPARIB+ irinotecan in?

INIPARIB+ irinotecan has been studied in two completed trials: NCT00540358, a Phase 2 study in triple negative metastatic breast cancer, and NCT00938652, a Phase 3 study of gemcitabine/carboplatin with or without BSI-201 in metastatic breast cancer. Both trials enrolled female patients in the United States.

Is INIPARIB+ irinotecan the same as BSI-201?

Yes, INIPARIB is also known as BSI-201, as referenced in clinical trial titles. The combination INIPARIB+ irinotecan is being studied in oncology indications. Sanofi has conducted trials using the BSI-201 designation for this PARP inhibitor in breast cancer and advanced solid tumors.