A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 10 December 2012
• Main ID: NCT01455532
• Date of registration: 07/10/2011
• Primary sponsor: Sanofi
• Public title: A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors
• Scientific title: 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
• Date of first enrolment: November 2011
• Target sample size: 160
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01455532
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: For site information, send an email with site number to

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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
asymptomatic.

- 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
doxorubicin.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neoplasm Malignant

Intervention(s)

Drug: Carboplatin

Drug: Gemcitabine

Drug: Iniparib (SAR240550-BSI-201)

Drug: Pegylated liposomal doxorubicin

Drug: Placlitaxel

Primary Outcome(s)

Assessment of iniparib as single agent and in combination with chemotherapeutic agents related dose limiting toxicities (DLTs) observed at first cycle [Time Frame: 3 - 4 weeks]

Secondary Outcome(s)

Pharmakokinetic (PK) parameters : t1/2z [Time Frame: 0, 0.5, 1, 1.33, 1.67, 2, 4, 5, 7 and 10 h post dose]

Pharmakokinetic (PK) parameters : tmax [Time Frame: 0, 0.5, 1, 1.33, 1.67, 2, 4, 5, 7 and 10 h post dose]

Pharmakokinetic (PK) parameters: AUC [Time Frame: 0, 0.5, 1, 1.33, 1.67, 2, 4, 5, 7 and 10 h post dose]

Pharmakokinetic (PK) parameters: Cmax [Time Frame: 0, 0.5, 1, 1.33, 1.67, 2, 4, 5, 7 and 10 h post dose]

Pharmakokinetic (PK) parameters: tlast [Time Frame: 0, 0.5, 1, 1.33, 1.67, 2, 4, 5, 7 and 10 h post dose]

To assess the antitumor effect of iniparib according to the Response Evaluation Criteria in Solid Tumors [RECIST]) Version 1.1 in patients with measurable disease [Time Frame: Up to 2 years]

Secondary ID(s)

TED11746

U1111-1118-6091

Source(s) of Monetary Support

Please refer to primary and secondary sponsors