Clinical trial NCT00745550: A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Official title: A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelofibrosis
Myeloproliferative Disorders
Polycythemia Vera
Essential Thrombocythemia
Keywords: SB1518
Chronic Idiopathic Myelofibrosis
Myeloproliferative disorders
Polycythemia Vera
Essential Thrombocythemia
JAK2 inhibitor
Lead sponsor: S*BIO
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF.


Eligibility criteria: Inclusion Criteria

* Subjects with CIMF (including post ET/PV MF) requiring therapy, including:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment
* Women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists
* Subjects who are able to understand and willing to sign the informed consent form

Exclusion Criteria

* Subjects with uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study unless the antibiotic is a CYP3A4 inducer/inhibitor
* Subjects known to be HIV-positive
* Subjects with known active hepatitis A, B, or C, or latent hepatitis B
* Women who are pregnant or lactating
* Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed)

Primary outcomes:
measure: Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily
timeFrame: Throughout the study
measure: Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose
timeFrame: Throughout the study
Secondary outcomes:
measure: Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF
timeFrame: Throughout the study
measure: Assess the pharmacokinetic profile of SB1518
timeFrame: Throughout the study
measure: Assess the pharmacodynamic profile of SB1518
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: John Seymour, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Melbourne Health
name: Andrew Roberts, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Adelaide Hospital
name: Bik To, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Rami Komrokji, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Martha Wadleigh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Ruben Mesa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komrokji RS, Seymour JF, Roberts AW, Wadleigh M, To LB, Scherber R, Turba E, Dorr A, Zhu J, Wang L, Granston T, Campbell MS, Mesa RA. Results of a phase 2 study of pacritinib (SB1518), a JAK2/JAK2(V617F) inhibitor, in patients with myelofibrosis. Blood. 2015 Apr 23;125(17):2649-55. doi: 10.1182/blood-2013-02-484832. Epub 2015 Mar 11.