Acute Myelogenous LeukemiaPhase 1/2NCT00719836
A Phase 1/2 Study of SB1518 for the Treatment of Advanced Myeloid Malignancies
A Phase 1/2 study testing SB1518 in people with Acute Myelogenous Leukemia and Chronic Myelogenous Leukemia, run by S*BIO at 3 sites in United States.
Trial summary
This 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 advanced myeloid malignancies; the second portion of the study is a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia
- What is being tested?
- SB1518
- Type of treatment
- Pill or oral medicine
- How many people
- 76 participants
- Where
- 3 sitesUnited States
- 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
- During the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following:
- Subjects with Acute Myelogenous Leukemia (AML)
- Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase
- Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis
- Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
- Subjects with Advanced Myelofibrosis (MF)
Show all 10Show fewer
- In Phase 2, subjects with CIMF (as well as post ET/PV MF)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
- Able to understand and willing to sign the informed consent form
Who cannot join
- Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase;
- 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;
- Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
- Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
- Known active hepatitis A, B, or C;
- Women who are pregnant or lactating.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Chicago Hospitals
Chicago, Illinois, 60637
MD Anderson Cancer Center
Houston, Texas, 77030
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
This 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 advanced myeloid malignancies; 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 chronic idiopathic myelofibrosis (CIMF).
- Conditions
- Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes, Myelofibrosis
- Being tested
- SB1518
- Keywords
- SB1518, Chronic Idiopathic Myelofibrosis, JAK2 Inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes, Primary Myelofibrosis
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 in subjects with advanced myeloid malignancies
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 (2)
Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies
Measured: Throughout the study
Assess the pharmacokinetic and 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 posted22 Jul 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 Acute Myelogenous LeukemiaStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- S*BIO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srdan Verstovsek, M.D, Ph.D, Principal investigator, M.D. Anderson Cancer CenterH. Joachim Deeg, M.D, Principal investigator, Fred Hutchinson Cancer CenterOlatoyosi M. Odenike, M.D., Principal investigator, The University of Chicago Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719836
- Sponsor's protocol ID
- SB1518-2007-001
- Status last verified
- Apr 2012
- First submitted
- 20 Jul 2008
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Verstovsek S, Odenike O, Singer JW, Granston T, Al-Fayoumi S, Deeg HJ. Phase 1/2 study of pacritinib, a next generation JAK2/FLT3 inhibitor, in myelofibrosis or other myeloid malignancies. J Hematol Oncol. 2016 Dec 8;9(1):137. doi: 10.1186/s13045-016-0367-x.
PubMed 27931243
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 SB1518 for the Treatment of Advanced Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT00719836
- Acronym / sponsor ID
- SB1518-2007-001
- Conditions
- Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes, Myelofibrosis
- Keywords
- SB1518, Chronic Idiopathic Myelofibrosis, JAK2 Inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 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
- 22 Jul 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.
This 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 advanced myeloid malignancies; 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 chronic idiopathic myelofibrosis (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 (10 listed)
- During the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
- Able to understand and willing to sign the informed consent form
Key exclusion criteria (6 listed)
- Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase;
- 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;
- Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study;
- Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);
- Known active hepatitis A, B, or C;
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 in subjects with advanced myeloid malignancies
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
2 secondary outcomes
Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies
Time frame: Throughout the study
Assess the pharmacokinetic and 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 27931243Verstovsek S, Odenike O, Singer JW, Granston T, Al-Fayoumi S, Deeg HJ. Phase 1/2 study of pacritinib, a next generation JAK2/FLT3 inhibitor, in myelofibrosis or other myeloid malignancies. J Hematol Oncol. 2016 Dec 8;9(1):137. doi: 10.1186/s13045-016-0367-x.
Related trials for Acute Myelogenous Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Srdan Verstovsek, M.D, Ph.D principal investigator
M.D. Anderson Cancer Center
H. Joachim Deeg, M.D principal investigator
Fred Hutchinson Cancer Center
Olatoyosi M. Odenike, M.D. principal investigator
The University of Chicago Hospitals
3 sites in 1 country: 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 Acute Myelogenous Leukemia and Chronic Myelogenous Leukemia, run by S*BIO at 3 sites in United States.
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 10 inclusion and 6 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 3 sites in United States. 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 in subjects with advanced myeloid malignancies (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 NCT00719836, 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.