Clinical Trials
Active ProgramsIniparib (BSI-201) Milestones
Metastatic triple-negative breast cancer - Expanded Access Protocol (EAP)
Iniparib (BSI-201) Expanded Access Protocol Approved
BiPar Sciences and sanofi-aventis obtained U.S. Food and Drug Administration (FDA) approval for an Expanded Access Protocol (EAP) for iniparib*, an investigational anticancer agent, for the treatment of metastatic triple negative breast cancer (mTNBC). Women in the United States with no comparable or satisfactory treatment options for mTNBC, and who do not qualify for an appropriate clinical trial, have the opportunity to access to this investigational compound through the EAP. It is important to note that iniparib has not yet been approved by the FDA as safe and effective.
To enroll in the EAP, a woman must meet specific clinical criteria which her healthcare professional will assess. A random selection process will ensure that all women with mTNBC who meet these criteria have equal opportunity to access the compound.
Following the January 27, 2011 announcement by sanofi-aventis and its subsidiary, BiPar, that the Phase III study of iniparib in combination with gemcitabine/carboplatin in metastatic Triple Negative Breast Cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression free survival, modifications have been made to the Expanded Access Protocol (EAP) and to the current Named Patient Programme (NPP).
Patients currently on iniparib and in either of these programs (EAP or NPP) will be provided with information about the protocol modifications by their treating physician. Patients who have concerns or questions should contact their physician for additional information.
Patients and healthcare professionals can learn more about the iniparib EAP at clinicaltrials.gov or by calling the information hotline +1 866 668 2232.
For more information about the iniparib EAP, click here.
Metastatic triple negative breast cancer (mTNBC) - Phase III
BiPar initiated a Phase III clinical trial in mTNBC in July 2009. This study has completed enrollment and top-line results were announced by sanofi-aventis and its subsidiary, BiPar, in January 2011 stating that the Phase III study of iniparib in combination with gemcitabine/carboplatin in metastatic Triple Negative Breast Cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression free survival.
Squamous Cell Lung Cancer - Phase III
BiPar is investigating iniparib in combination with chemotherapy as first-line therapy for patients with advanced squamous cell lung cancer.
See information about the lung cancer study at clinicaltrials.gov or call the BiPar Sciences Call Center at 1-866-668-2232.
Triple negative breast cancer (neoadjuvant study) - Phase II
Iniparib is being evaluated as a neoadjuvant combination with chemotherapy in a Phase II clinical trial for patients with triple negative breast cancer. The study will investigate whether patients are responsive to treatment with iniparib prior to surgery.
See information about the neoadjuvant breast cancer study on clinicaltrials.gov.
Ovarian Cancer - Phase II
Two Phase II studies evaluating iniparib in combination with gemcitabine/carboplatin in platinum-sensitive and platinum-resistant ovarian cancers began in December 2009. A Phase IIa study of iniparib in combination with topotecan in patients with advanced ovarian cancer has completed enrollment.
See information about the ovarian cancer studies on clinicaltrials.gov.
Glioblastoma multiforme (GBM) - Phase I/II
BiPar Sciences is collaborating with the New Approaches to Brain Tumor Therapy (NABTT) consortium, a research organization sponsored by the National Cancer Institute, to evaluate iniparib in patients with GBM, the most common brain cancer in adults.
See information about the glioma study at clinicaltrials.gov.
Pancreatic cancer - Phase IB
BiPar Sciences is investigating iniparib in patients with pancreatic cancer with BRCA mutations; Pancreatic cancer is an aggressive disease with limited available treatment options.
See information about the pancreatic cancer study at clinicaltrials.gov.
Information about all clinical studies of iniparib is available on clinicaltrials.gov.
*Iniparib is the United States Adopted Name (USAN) for BSI-201.