A clinical trial with Momelotinib in subjects with Polycythemia Vera & Essential Thrombocythemia.

• Conditions: subjects with either polycythemia vera (PV) or essential thrombocythemia (ET); MedDRA version: 17.0Level: PTClassification code 10036057Term: Polycythaemia veraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004105-11-DE
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-23
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age = 18 years old
2.Diagnosis of either PV or ET as defined by the 2008 WHO Diagnostic Criteria
3.Requires treatment for PV or ET, in the opinion of the study investigator
4.Intolerant of, resistant to, or refuses current or available treatment for PV or ET
5.Direct bilirubin = 2.0 x upper limit of normal (ULN)
6.AST (SGOT) and ALT (SGPT) = 3X ULN
7.Calculated creatinine clearance (CrCl) of = 45 mL/min
8.Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
9.Life expectancy > 24 weeks
10.Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years postmenopausal)
11.Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
12.Females who are nursing must agree to discontinue nursing before the first dose of IP
13.Able to comprehend and willing to sign informed consent form (ICF)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Prior splenectomy
2.Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection (subjects receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the study), active or chronic bleeding event within 4 weeks prior to first dose of IP, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
3.History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for = 1 year prior to randomization, adequately treated Stage 1 or 2 cancer currently in complete remission (CR), or any other cancer that has been in CR for = 5 years.
4.Major surgery within 28 days of first dose of IP
5.Known positive status for human immunodeficiency virus (HIV)
6.Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
7.Myeloproliferative neoplasm-directed therapy, other than aspirin, hydroxyurea, anagrelide, and/or phlebotomy, within 21 days prior to the first dose of IP
8.Anagrelide within 7 days prior to the first dose of IP
9.Unresolved non-hematologic toxicities from prior therapies that are > CTCAE Grade 1
10.Presence of peripheral neuropathy = Grade 2
11.Incomplete recovery from any surgery performed within 4 weeks prior to the first dose of IP
12.Unwilling or unable to take oral medication
13.Prior use of a JAK1 or JAK2 inhibitor
14.Use of strong CYP3A4 inducers within 1 week prior to the first dose of IP
15.Known hypersensitivity to the study investigational medicinal products, the metabolites, or formulation excipients
16. QTc interval > 450msec, unless attributed to bundle branch block

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified