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)
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
