An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer

Overview

About this study

The purpose of this study is to offer pre-approval drug access of iniparib combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Histologically documented breast cancer (either primary or metastatic site) that is ER-negative, PR-negative, and HER2 non-over expressing by immunohistochemistry (0, 1) or in situ hybridization (ISH) including; fluorescence (FISH) in situ hybridization / chromogenic in situ hybridization (CISH) with a ratio < 2.0
One to three prior chemotherapy regimens in the metastatic setting
- Prior adjuvant/neoadjuvant therapy is allowed
- Prior Gemcitabine and/or Platinum agents are allowed
Metastatic breast cancer (Stage IV)
Female, ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
Organ and marrow function as follows
- Absolute neutrophil count (ANC) ≥1500/mm3
- Platelets ≥100,000/dL
- Hemoglobin ≥9 g/dL
- Bilirubin ≤1.5 mg/dL
- Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60 mL/min
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement
Females of child bearing potential
- Documented negative pregnancy test within two weeks of EAP entry
- Agreement to acceptable birth control during the duration of the EAP therapy
Capability to understand and comply with the protocol
Signed informed consent document

Exclusion Criteria

Systemic anticancer therapy within 14 days of the first dose of study drug
Has not recovered to grade ≤1 from adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0, with the exception of alopecia, related to anticancer therapy prior to the first dose of study drug
Major medical conditions that might affect EAP participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
Brain metastases requiring steroids or expected to require other therapeutic intervention during study participation, including WBRT and intrathecal therapy
- Must be > 21-days from neurosurgical intervention
Pregnant or breastfeeding
Inability or unwillingness to abide by the EAP protocol or cooperate fully with the investigator or designee
Enrollment is limited and will be determined by a validated Random-Selection Process administered by NORD (National Organization of Rare Disorders)

More information

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