Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)
Trial ID or NCT#
NCT00935987
Status
NOT RECRUITING
Purpose
This study seeks to (i) determine a safe and tolerated dose of CYT387 (momelotinib) given to patients with PMF, post-PV or post-ET and, (ii) assess the effectiveness of orally-administered CYT387 as a treatment for PMF, post-PV or post-ET.
Official Title
A Phase I/II, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis.
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Diagnosis of PMF or post-polycythemia Vera (PV) or post-essential Thrombocythemia (ET) MF as per revised World Health Organization (WHO) criteria. - High-risk or Intermediate-2 risk MF (as defined by the International Prognostic Scoring System [IPSS]; Appendix 13.6); or intermediate-I risk MF (IPSS) associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy. - Must be at least 18 years of age with life expectancy of ≥ 12 weeks. - Must be able to provide informed consent and be willing to sign an informed consent form. - Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. - Must have evidence of acceptable organ function within 7 days of initiating study drug as evidenced by the following: - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis) - Bilirubin ≤ 2.0 x ULN or direct bilirubin < 1.0 - Serum creatinine ≤ 2.5 x ULN - Absolute neutrophil count ≥ 500/µL - Platelet count ≥ 50,000/µL - Females of childbearing potential must have a negative pregnancy test within 4 days of initiating study drug.
Exclusion Criteria:
- - Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug. - Incomplete recovery from major surgery within four weeks of study entry. - Radiation therapy within four weeks of study entry. - Women of childbearing potential, unless surgically sterile for at least 3 months (ie, hysterectomy), OR postmenopausal for at least 12 months (FSH > 30 U/mL), OR unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed. - Men who partner with a woman of childbearing potential, unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through to the end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed. - Females who are pregnant or are currently breastfeeding. - Known positive status for HIV. - Clinically active hepatitis B or C. - Diagnosis of another malignancy unless free of disease for at least three years following therapy with curative intent. Patients with early-stage basal cell or squamous cell skin cancer, cervical intraepithelial neoplasia, cervical carcinoma in situ or superficial bladder cancer may be eligible to participate at the Investigator's discretion. - Any acute active infection. - Cardiac dysrhythmias requiring treatment, or prolongation of the QTc (Fridericia) interval to > 450 msec for males or > 470 msec for females at prestudy screening, unless attributable to pre-existing bundle branch block. - Presence of ≥ Grade 2 peripheral neuropathy. - Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to initiation of study drug. - Uncontrolled inter current illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
Investigator(s)
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Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
