Status:
COMPLETED
Safety and Pharmacokinetics of SAR240550 (BSI-201) Twice Weekly in Patients With Advanced Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Advance Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
Primary Objective: \- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens Secondary Objectives: * To determine the dose limiting toxicity (DLT) of SAR24...
Detailed Description
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study cycle(s), followed by a 30 day follow-up.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Histologically or cytologically documented advanced solid tumor that was refractory to standard therapy or for which no standard therapy is available
- Exclusion criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Known hematological malignancies
- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
- Myocardial infarction within 6 months of study Day 1, unstable angina, congestive heart failure with New York Heart Association \>class II, uncontrolled hypertension
- Active human immunodeficiency virus infection, hepatitis C virus, or chronic hepatitis B infection
- Major surgery within 28 days of study Day 1
- Not recovered from all previous therapies (i.e. radiation, surgery, and medications)
- Adverse events related to previous therapies must be Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 (except alopecia) at screening or returned to the subject's baseline prior to their most recent previous therapy
- Inadequate organ and bone marrow function Radiation therapy within 14 days of study Day 1
- Chemotherapy or antibody therapy for treatment of underlying malignancy within 21 days of study Day 1
- Concurrent or prior (within 7 days of study Day 1) anticoagulation therapy
- Currently enrolled or was enrolled within 30 days of completing other investigational drug study, or receiving other investigational agent not approved for any indications
- Subject who had been previously enrolled in this study . Not available for follow-up assessment
- Any kind of disorder that compromised the ability of the subject to give written informed consent and/or comply with the study procedures
- Patient who is judged by the investigator as not suitable for participation in the study
- 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 :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01213381
Start Date
September 1 2010
End Date
February 1 2013
Last Update
May 24 2013
Active Locations (2)
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1
Sanofi-Aventis Investigational Site Number 392001
Kobe, Japan
2
Sanofi-Aventis Investigational Site Number 392002
Matsuyama, Japan