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Therapeutic Areas: Oncology | Family Medicine
Disease Category: Chemotherapy
Location: United States, NY

Clinical Trial Details

Overview

Research Study Summary

An Open-Label, Multiple-Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Adult Cancer Patients with Chemotherapy Induced Thrombocytopenia

Purpose

The purpose of this study is as follows: (1) to look at how safe and how well adult cancer patients who have chemotherapy-induced thrombocytopenia respond to taking the investigational drug, ONO-7746; (2) to help the investigators learn if the drug will prevent the low platelet count that is common in these patients; (3) to study the blood levels of ONO-7746; and (4) to study how ONO-7746 may or may not be able to fix thrombocytopenia during treatment.

Patient Inclusion Criteria:

  • Males or females aged 18 years and older at the time of signing the Informed Consent Form
  • Must have a confirmed diagnosis of a histologically- or cytologically-confirmed solid tumor and are receiving the same chemotherapy on Day 1 as in the last 21-day chemotherapy cycle prior to study enrollment
  • Have experienced thrombocytopenia as evidenced by platelet count

Patient Exclusion Criteria:

  • History of platelet disorders or dysfunction, or other bleeding disorder conditions
  • History of arterial thrombosis, pulmonary embolism or other venous thrombosis within 1 year of screening or drug-induced thrombocytopenia other than chemotherapies
  • History of unstable angina, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmia, or myocardial infarction within 3 months of study enrollment
  • Female subjects who are pregnant, wanting to become pregnant, or lactating

To Learn more
Phase

1

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

Mohammad Ghalib
The Harold & Muriel Block Institute for Clinical and Translational Research at Einstein & Montefiore
Montefiore Medical Center
Department of Oncology
111 East 210th Street
Bronx, NY 10467
Phone: 718-405-8515

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 181289

Date Last Changed: July 18, 2013


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