Back to resultsA Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
Primary Purpose
Myelofibrosis, Myeloproliferative Disorders, Polycythemia Vera
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SB1518
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis focused on measuring SB1518, Chronic Idiopathic Myelofibrosis, Myeloproliferative disorders, Polycythemia Vera, Essential Thrombocythemia, JAK2 inhibitor
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)
Sites / Locations
- Mayo Clinic
- H. Lee Moffitt Cancer Center & Research Institute
- Dana-Farber Cancer Institute
- Peter MacCallum Cancer Centre
- Royal Melbourne Hospital
- Royal Adelaide Hospital
Outcomes
Primary Outcome Measures
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose
Secondary Outcome Measures
Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF
Assess the pharmacokinetic profile of SB1518
Assess the pharmacodynamic profile of SB1518
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00745550
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S*BIO
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis, Myeloproliferative Disorders, Polycythemia Vera, Essential Thrombocythemia
Keywords
SB1518, Chronic Idiopathic Myelofibrosis, Myeloproliferative disorders, Polycythemia Vera, Essential Thrombocythemia, JAK2 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB1518
Intervention Description
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
Primary Outcome Measure Information:
Title
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily
Time Frame
Throughout the study
Title
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF
Time Frame
Throughout the study
Title
Assess the pharmacokinetic profile of SB1518
Time Frame
Throughout the study
Title
Assess the pharmacodynamic profile of SB1518
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Seymour, M.D.
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Roberts, M.D.
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bik To, MD
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rami Komrokji, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martha Wadleigh, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruben Mesa, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25762180
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.
Results Reference
derived
Learn more about this trial
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
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