A Phase II Trial to Evaluate the Activity of Imetelstat (GRN163L) in Patients with Essential Thrombocythemia who Require Cytoreduction and Have Failed or Are Intolerant to Previous Therapy, or who Refuse Standard Therapy

Geron Corporation0 sites40 target enrollmentDecember 7, 2010

Overview

No summary available.

Registry

who.int

Start Date

December 7, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-Willing and able to sign an informed consent.
•\-Male or female, aged 18 years or older.
•\-Patients with ET requiring cytoreduction who have failed or are intolerant to at least one prior therapy, or who refuse standard therapy.
•\-Confirmed diagnosis of ET by WHO criteria.
•\-ECOG performance status 0–2\.
•\-Laboratory criteria (within 14 days of first study drug administration) in compliance with protocol limits.
•\-Any clinically significant toxicity from previous cancer treatments and/or major surgery must have recovered to Grade 0\-1 prior to initiation of study treatment.
•\-Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and for at least 12 weeks after the last study treatment with imetelstat.
•\-Male patients must agree to use effective birth control for themselves or their partner during and for 12 weeks after the last study treatment with imetelstat.
•Are the trial subjects under 18? no

•\-Women who are pregnant or breast feeding.
•\-Prior stem cell transplantation.
•\-Investigational therapy within 4 weeks prior to first study drug administration.
•\-Clinically significant cardiovascular disease or condition including: Uncontrolled congestive heart failure (CHF); Need for antiarrhythmic therapy for a ventricular arrhythmia; Clinically significant severe conduction disturbance per the Investigator’s discretion; Ongoing angina pectoris requiring therapy; New York Heart Association (NYHA) Class II, III, or IV cardiovascular disease.
•\-Known positive serology for human immunodeficiency virus (HIV).
•\-Serious co\-morbid medical conditions, including active or chronically recurrent bleeding, clinically relevant active infection, cirrhosis, and chronic obstructive or chronic restrictive pulmonary disease per the Investigator’s discretion.
•\-Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study.