A Phase 1/1b Dose Escalation Study Evaluating Iniparib (BSI201/SAR240550) as a Single Agent and in Combination With Chemotherapeutic Regimens in Patients With Solid Tumors
- Capable of understanding and complying with the protocol requirements, and have
signed the informed consent document
- ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- To have histological or cytological evidence of a diagnosis of cancer that is
advanced and/or metastatic disease; that is refractory to standard therapy and/or
therapies known to provide clinical benefit or for which no standard therapy exists
- For phase 1b, patients for whom the backbone chemotherapy (dose and schedule) can be
considered as a standard therapeutic regime for their cancer.
- Have measurable disease or non-measurable disease, defined according to RECIST
Version 1.1. Patients with skin only metastases are eligible, if the appropriate
photography documentation (including measurement) of the skin metastases is provided.
- Adequate organ and bone marrow function
- Willingness, if not postmenopausal or surgically sterile, to abstain from sexual
intercourse or employ an effective barrier method of contraception during the study
drug administration and for a period of 6 months following the last dose.
- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to start of treatment. Women of childbearing potential or men
with partners of childbearing potential must use effective birth control measures
during treatment, and at least 6 months after the last dose of study treatment. If a
woman becomes pregnant or suspects she is pregnant while participating in this study,
she must agree to inform her treating physician immediately. Sexually active men must
agree to use a medically acceptable form of birth control during treatment and at
least 6 months after the last dose. If a female partner becomes pregnant during
course of study the treating physician should be informed immediately.
- Systemic anticancer therapy within 14 days before the first dose of study drug.
- Known allergy or hypersensitivity to components of the iniparib, gemcitabine,
paclitaxel, PLD,or carboplatin formulation.
- Not recovered to Grade ≤1 from adverse events (AE), per NCI-CTCAE Version 4.03 or to
within 10% of pre-treatment baseline values, due to investigational drugs, radiation,
or other medications administered more than 30 days before enrollment in this study.
Alopecia at screening is not exclusionary.
- Prior radical (curative) radiation therapy for treatment of cancer ≥25% of the bone
marrow (1). Prior radiation to the whole pelvis is not allowed. Prior radical
radiotherapy must be completed at least 4 weeks before study entry.
- Patients who have received palliative radiation therapy for symptomatic metastases
must have completed treatment ≥14 days prior to initiation of study treatment.
- Active brain metastases. Patients with treated brain metastases are eligible, if 1.
Radiation therapy was completed at least 2 weeks prior to study treatment; 2.
Follow-up scan shows no disease progression; and 3. Patient does not require
steroids. Screening for brain metastases is not required if the patient is
- Clinically significant cardiac disease including congestive heart failure (New York
Heart Association Class III or IV), including pre-existing ventricular arrhythmia or
conduction abnormality requiring medication, or cardiomyopathy or history of a
myocardial infarction within the last 6 months
- Other major medical condition (eg, uncontrolled pulmonary, renal, or hepatic
dysfunction, uncontrolled infection) which the Investigator feels might compromise
the patient's effective and safe participation in the trial.
- Pregnant or breastfeeding
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBSAg), or Hepatitis C Antibodies (HCAb). Testing is not required
unless circumstances warrant confirmation.
- Patients with acute or chronic leukemia or with any other disease likely to have a
significant bone marrow infiltration (screening not required).
- Prior treatment with gemcitabine, carboplatin, paclitaxel, or Pegylated liposomal
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.