A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.
Inclusion Criteria
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.