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Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)
Trial ID: NCT01236638
This extension protocol to the core study CCL09101 allows patients who have tolerated the drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of the core protocol. Long term safety and efficacy of CYT387 (momelotinib) will be evaluated.
A Phase II, Open-Label Extension Study Evaluating the Long Term Safety, Tolerability & Efficacy of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
- Patients must have completed at least 9 cycles of treatment on the core study '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 (CCL09101)' and achieved stable disease (SD), clinical improvement (CI),
partial remission (PR) or complete remission (CR) using the International Working
Group consensus criteria for treatment responses in myelofibrosis with myeloid
metaplasia (IWG-MRT; Tefferi et al., 2006)
- 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:
- SGOT (AST) or SGPT (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
- Bilirubin <= 2.0 x ULN or direct bilirubin < 1.0
- Serum creatinine <= 2.5 x ULN
- Absolute neutrophil count >= 500/µL
- Platelet count >= to 20,000/µL
- Females of childbearing potential must have a negative pregnancy test within 4 days of
entering the extension protocol.
- A delay of 4 weeks or more since the last preceding dose of CYT387 on the CCL09101
- Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g.,
thalidomide), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or
equivalent, or growth factor treatment (e.g., 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
(i.e., 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 pre-study 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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