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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


Phase 1
20 Years
75 Years
Open (Enrolling)
Both
Advanced Solid Tumors

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Trial Information

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


The duration of the study for each patient will include an up to 4-week screening phase,
21-day study treatment cycles, an end of treatment visit and a follow-up period.

Inclusion Criteria


Inclusion criteria:

- 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
study-specific procedures.

Exclusion criteria:

- 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
radiotherapy),

- 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
norms.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TCD11270

NCT ID:

NCT01293630

Start Date:

December 2010

Completion Date:

September 2013

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

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