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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

Phase 1
18 Years
Open (Enrolling)
Neoplasm Malignant

Thank you

Trial Information

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

The duration of the study for an individual patient will include a period to assess
eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1
cycle (3 weeks or 4 weeks depending on regimen) of study treatment, and an end-of-treatment
visit at least 30 days following the last administration of study drug. However, treatment
may continue until precluded by toxicity, progression, or death.

Inclusion Criteria

Inclusion criteria:

- 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.

Exclusion criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of iniparib as single agent and in combination with chemotherapeutic agents related dose limiting toxicities (DLTs) observed at first cycle

Outcome Time Frame:

3 - 4 weeks

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

August 2013

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms



Investigational Site Number 840004 Santa Monica, California  90403
Investigational Site Number 840006 San Antonio, Texas  78229
Investigational Site Number 840002 Scottsdale, Arizona  85258
Investigational Site Number 840007 St Louis, Missouri  63110
Investigational Site Number 840001 Cincinnati, Ohio  45267-0542
Investigational Site Number 840010 Augusta, Georgia  30912