Status:
COMPLETED
A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Neoplasm Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary Objective: * To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent and in combination with chemotherapeutic regimens in patients with advanced solid tumors th...
Detailed Description
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 week...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01455532
Start Date
November 1 2011
End Date
April 1 2014
Last Update
October 22 2014
Active Locations (6)
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1
Investigational Site Number 840002
Scottsdale, Arizona, United States, 85258
2
Investigational Site Number 840004
Los Angeles, California, United States, 90048
3
Investigational Site Number 840010
Augusta, Georgia, United States, 30912
4
Investigational Site Number 840007
St Louis, Missouri, United States, 63110