Status:
COMPLETED
Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)
Lead Sponsor:
Sierra Oncology LLC - a GSK company
Conditions:
Primary Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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-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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00935987
Start Date
November 1 2009
End Date
April 1 2012
Last Update
February 1 2019
Active Locations (6)
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1
Stanford Cancer Center
Stanford, California, United States, 94305-5821
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050