An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin Every 3 Weeks in Patients With Advanced Solid Tumors
- Patients with advanced solid tumor for which the combination paclitaxel and
carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer.
- Patients who have signed and dated an Institutional Review Board (IRB)-approved
patient informed consent form prior to study enrollment or performance of any
- Less than 20 or above 75 years of age ECOG performance status ≥2.
- Patients with more than 1 line of previous chemotherapy for advanced or metastatic
disease (adjuvant/neoadjuvant and targeted agents [eg gefitinib] excluded)
- Concurrent treatment with any other anticancer therapy (except palliative
- Women of childbearing potential who does not agree with contraception.
- Washout period of less than 28 days from prior anticancer therapies
- Symptomatic brain metastases and carcinomatous leptomeningitis.
- Other serious illness or medical conditions
- Current peripheral neuropathy ≥grade 2 and ototoxicity,
- Absolute neutrophils counts<1.5 x 10E9/L. − Platelets count<100 x 10E9/L. −
hemoglobin <9.0 g/dL (without red blood cell transfusion within 28 days before the
test). − Creatinine Clearance<55 mL/min. − Total bilirubin >upper normal limits of
the institutional norms. − ALT/AST >1.5 times the upper normal limits of the
institutional norms. − AP>2.5 times the upper normal limits of the institutional
- Medical history of myocardial infarction, angina pectoris, congestive heart failure,
coronary artery bypass graft , arrhythmia , stroke or history of arterial or venous
thrombo-embolism within the past 180 days requiring anticoagulants.
- Patient with a LVEF <50% by echocardiography.
- Patient with uncontrolled hypertension and patient with organ damage related to
hypertension such as left ventricular hypertrophy or grade 2 ocular fundoscopic
changes or kidney impairment.
- Hypertension defined as systolic BP >140 mmHg or diastolic BP >90 mmHg on two
repeated measurements at 30 minutes interval.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.