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

• Conditions: Essential thrombocythemia; MedDRA version: 16.0Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-023076-10-DE
• Lead Sponsor: Geron Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-07
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified