MyelofibrosisPhase 1/2NCT00745550
A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
A Phase 1/2 study testing SB1518 in people with Myelofibrosis and Myeloproliferative Disorders, run by S*BIO at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Myeloproliferative Disorders, Polycythemia Vera
- What is being tested?
- SB1518
- Type of treatment
- Pill or oral medicine
- How many people
- 55 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Aug 2008to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Mayo Clinic
Scottsdale, Arizona, 85259
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Australia3 sites
Royal Adelaide Hospital
Adelaide, 5000
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3002
Royal Melbourne Hospital
Melbourne, Victoria, 3050
About this study
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.
- Being tested
- SB1518
- Keywords
- SB1518, Chronic Idiopathic Myelofibrosis, Myeloproliferative disorders, Polycythemia Vera, Essential Thrombocythemia, JAK2 inhibitor
- Medical subject headings
- Primary Myelofibrosis, Myeloproliferative Disorders, Polycythemia Vera, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB1518Drug
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily
Measured: Throughout the study
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose
Measured: Throughout the study
Secondary outcomes (3)
Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF
Measured: Throughout the study
Assess the pharmacokinetic profile of SB1518
Measured: Throughout the study
Assess the pharmacodynamic profile of SB1518
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- S*BIO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Seymour, M.D., Principal investigator, Peter MacCallum Cancer Centre, AustraliaAndrew Roberts, M.D., Principal investigator, Melbourne HealthBik To, MD, Principal investigator, Royal Adelaide HospitalRami Komrokji, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research InstituteMartha Wadleigh, MD, Principal investigator, Dana-Farber Cancer InstituteRuben Mesa, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745550
- Sponsor's protocol ID
- SB1518-2008-003
- Status last verified
- Apr 2012
- First submitted
- 2 Sep 2008
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25762180
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Oral SB1518 in Subjects With Chronic Idiopathic Myelofibrosis
- ClinicalTrials.gov ID
- NCT00745550
- Acronym / sponsor ID
- SB1518-2008-003
- Keywords
- SB1518, Chronic Idiopathic Myelofibrosis, Myeloproliferative disorders, Polycythemia Vera, Essential Thrombocythemia, JAK2 inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- S*BIOIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB1518SB1518 taken orally daily for 28 consecutive days in a 28-day cycle | Drug | – |
Primary outcome
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily
Time frame: Throughout the study
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
3 secondary outcomes
Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF
Time frame: Throughout the study
Assess the pharmacokinetic profile of SB1518
Time frame: Throughout the study
Assess the pharmacodynamic profile of SB1518
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Derived from this study: PubMed 25762180Komrokji 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Seymour, M.D. principal investigator
Peter MacCallum Cancer Centre, Australia
Andrew Roberts, M.D. principal investigator
Melbourne Health
Bik To, MD principal investigator
Royal Adelaide Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SB1518 in people with Myelofibrosis and Myeloproliferative Disorders, run by S*BIO at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily (time frame: Throughout the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.