Status:
COMPLETED
Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
Lead Sponsor:
Sierra Oncology LLC - a GSK company
Conditions:
Primary Myelofibrosis
Post-Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders o...
Eligibility Criteria
Inclusion
- Diagnosis of PMF or post-ET/PV MF as per revised World Health Organization (WHO) criteria (Section 16.4, Appendix 3).
- High-risk or Intermediate-2 risk MF (as defined by the International Prognostic Scoring System \[IPSS\]; Section 16.6, Appendix 5); or Intermediate-1 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 (Section 16.3, Appendix 2).
- Must have evidence of acceptable organ function within 7 days of initiating study drug as evidenced by the following:
- AST or ALT less than or equal 2.5 x upper limit of normal (ULN) (or less than or equal to 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis)
- Direct Bilirubin less than or equal to 2.0 x ULN
- Serum creatinine less than or equal to 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
- 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.
- Positive serologic testing for hepatitis B (HBsAg and HBcAb total) and hepatitis C (anti-HCV)
- 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 participate at the Investigator's discretion.
- Any acute active infection.
- Cardiac dysrhythmias requiring treatment, or prolongation of the QTc (Fridericia) interval to \>480 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 intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01423058
Start Date
August 1 2011
End Date
June 1 2014
Last Update
February 4 2019
Active Locations (6)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
3
MD Anderson Cancer Center, The University of Texas
Houston, Texas, United States, 77030
4
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84108