LeukemiaPhase 2NCT01436084
SB1518 for Patients With Myelodysplastic Syndrome (MDS)
A Phase 2 study testing SB1518 in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if SB1518 can help to control myelodysplastic syndrome. The safety of the drug will also be studied. SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- SB1518
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with MDS by the IPSS classification including low, int-1, int-2, and high risk are eligible. Patients should have received at least one line of prior therapy including growth factors, lenalidomide, or hypomethylating agents.
- Signed informed consent.
- Age >/= 18 years old.
- Patients must have the following non-hematologic values: Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) </= 2.5 x Upper Limit of Normal (ULN) if both are available or </= 5.0 x ULN if hepatic involvement is present as determined by the investigator; Serum bilirubin </=2 x ULN; Serum creatinine </= 2 x ULN or 24-hour creatinine clearance >/= 50 ml/min
- Patients, if sexually active, must agree to use appropriate forms birth control.
Who cannot join
- Uncontrolled intercurrent illness, including but not limited to ongoing active infection or psychiatric illness or social situations that the treating physician judges would limit compliance with study requirements. Patients receiving antibiotics for infections that are under control may be included in the study.
- History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within 6 months prior to study enrollment;
- New York Heart Association Class III or IV congestive heart failure;
- Ongoing cardiac dysrhythmias of Grade >/= 2, atrial fibrillation of any grade, QTc prolongation > 470 ms or other factors that increase the risk of QT prolongation (e.g., heart failure; hypokalemia, defined as serum potassium < 3.0 mEq/L; family history of long QT interval syndrome);
- Required use of a concomitant medication known to prolong the QT interval significantly.
- Known HIV seropositivity;
- Known active hepatitis A, B, or C;
- Women who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of SB1518 for Patients With Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if SB1518 can help to control myelodysplastic syndrome. The safety of the drug will also be studied.
SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take SB1518 by mouth 1 time every day. You can take it with or without food, and it should be taken at the same time every day.
You will receive your monthly supply of SB1518 during your clinic visit. The capsules should not be opened or crushed. Do not touch the powder in the capsules. If you do, wash effected areas thoroughly with water.
Each study cycle is 28 days.
Study Visits:
At every study visit, you will be asked about any drugs you may be taking, and any side effects you have had.
One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine tests.
On Day 1 of Cycles 2 and beyond, blood (about 2 tablespoons) will be collected for routine tests.
On Day 28 of each cycle, you will have a bone marrow aspirate and/or biopsy to check the status of the disease. If the screening bone marrow test showed unusual genetic test results, these samples will be used for cytogenetic testing. If you have a response to therapy, you will have a bone marrow aspirate and/or biopsy every 3 cycles, if your doctor thinks it needed.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, you are able to undergo allogeneic bone marrow transplantation, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit.
End-of-Treatment Visit:
At 30 days after your last dose of study drug, you will have an end-of-treatment visit.
- You will be asked about any drugs you may be taking, and any side effects you have had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a bone marrow aspirate and/or biopsy to check the status of the disease, if your doctor thinks it is needed.
This is an investigational study. SB1518 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 40 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- SB1518
- Keywords
- Leukemia, Myelodysplastic syndrome, MDS, SB1518
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB1518Drug
400 mg taken orally, once daily without regard of food, 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| SB1518 | Experimental | 400 mg orally a day for 28 day cycle. Receives: Drug: SB1518 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Overall Response
Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still > 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.
Measured: 28 days to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Colloborating sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- S*BIO
- Responsible party
- Sponsor
- Investigators
- Guillermo Garcia-Manero, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436084
- Sponsor's protocol ID
- 2011-0427
- Status last verified
- Jun 2016
- First submitted
- 15 Sep 2011
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of SB1518 for Patients With Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT01436084
- Acronym / sponsor ID
- 2011-0427
- Conditions
- Leukemia
- Keywords
- Leukemia, Myelodysplastic syndrome, MDS, SB1518
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Colloborating sponsor decision.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- S*BIO
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Posted 15 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if SB1518 can help to control myelodysplastic syndrome. The safety of the drug will also be studied.
SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take SB1518 by mouth 1 time every day. You can take it with or without food, and it should be taken at the same time every day.
You will receive your monthly supply of SB1518 during your clinic visit. The capsules should not be opened or crushed. Do not touch the powder in the capsules. If you do, wash effected areas thoroughly with water.
Each study cycle is 28 days.
Study Visits:
At every study visit, you will be asked about any drugs you may be taking, and any side effects you have had.
One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine tests.
On Day 1 of Cycles 2 and beyond, blood (about 2 tablespoons) will be collected for routine tests.
On Day 28 of each cycle, you will have a bone marrow aspirate and/or biopsy to check the status of the disease. If the screening bone marrow test showed unusual genetic test results, these samples will be used for cytogenetic testing. If you have a response to therapy, you will have a bone marrow aspirate and/or biopsy every 3 cycles, if your doctor thinks it needed.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, you are able to undergo allogeneic bone marrow transplantation, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment visit.
End-of-Treatment Visit:
At 30 days after your last dose of study drug, you will have an end-of-treatment visit.
- You will be asked about any drugs you may be taking, and any side effects you have had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a bone marrow aspirate and/or biopsy to check the status of the disease, if your doctor thinks it is needed.
This is an investigational study. SB1518 is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 40 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB1518 | Experimental | Drug: SB1518400 mg orally a day for 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with MDS by the IPSS classification including low, int-1, int-2, and high risk are eligible. Patients should have received at least one line of prior therapy including growth factors, lenalidomide, or hypomethylating agents.
- Signed informed consent.
- Age >/= 18 years old.
- Patients must have the following non-hematologic values: Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) </= 2.5 x Upper Limit of Normal (ULN) if both are available or </= 5.0 x ULN if hepatic involvement is present as determined by the investigator; Serum bilirubin </=2 x ULN; Serum creatinine </= 2 x ULN or 24-hour creatinine clearance >/= 50 ml/min
- Patients, if sexually active, must agree to use appropriate forms birth control.
Key exclusion criteria (8 listed)
- Uncontrolled intercurrent illness, including but not limited to ongoing active infection or psychiatric illness or social situations that the treating physician judges would limit compliance with study requirements. Patients receiving antibiotics for infections that are under control may be included in the study.
- History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within 6 months prior to study enrollment;
- New York Heart Association Class III or IV congestive heart failure;
- Ongoing cardiac dysrhythmias of Grade >/= 2, atrial fibrillation of any grade, QTc prolongation > 470 ms or other factors that increase the risk of QT prolongation (e.g., heart failure; hypokalemia, defined as serum potassium < 3.0 mEq/L; family history of long QT interval syndrome);
- Required use of a concomitant medication known to prolong the QT interval significantly.
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 |
|---|---|---|
| SB1518400 mg taken orally, once daily without regard of food, 28 day cycle. | Drug | SB1518 |
Primary outcome
Number of Participants With Overall Response
Time frame: 28 days to one year
Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still > 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson WebsiteLink provided by the sponsor.
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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.
Guillermo Garcia-Manero, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB1518 in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 15 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Overall Response (time frame: 28 days to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2016.