NCT01436084

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 15, 2016

Completed
Last Updated

July 13, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

September 15, 2011

Results QC Date

May 10, 2016

Last Update Submit

June 14, 2016

Conditions

Leukemia

Keywords

LeukemiaMyelodysplastic syndromeMDSSB1518

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 days to one year

Study Arms (1)

SB1518

EXPERIMENTAL

400 mg orally a day for 28 day cycle.

Drug: SB1518

Interventions

SB1518DRUG

400 mg taken orally, once daily without regard of food, 28 day cycle.

SB1518

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaMyelodysplastic Syndromes

Interventions

11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Results Point of Contact

Title
Guillermo Garcia-Manero, MD / Professor, Leukemia
Organization
University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org
1-877-MDA-6789

Study Officials

  • Guillermo Garcia-Manero, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 19, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 13, 2016

Results First Posted

June 15, 2016

Record last verified: 2016-06

Locations

US(1)