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Trial ID: NCT00935987
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.
- 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
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- 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.
- 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
- 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
- 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
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