Overview

Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)

Status:
Terminated

Trial end date:
2017-06-03

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn if pacritinib, either alone or in combination with azacitidine or decitabine, can help to control MDS. The safety of this drug and drug combination will also be studied.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

CTI BioPharma

Treatments:

Azacitidine
Decitabine

Criteria

Inclusion Criteria:

1. Signed informed consent indicating that patients are aware of the investigational
nature of this study, in keeping with the policies of MD Anderson Cancer Center
(MDACC), must be obtained prior to any study specific procedures.

2. Patients with a histologically confirmed diagnosis of MDS by World Health Organization
(WHO) classification, and lower-risk MDS as defined by the IPSS classification (Low or
Int-1 disease) or R-IPSS classification (Very Low or Low) are eligible. Patients with
MDS/MPD overlap syndromes including CMML are also eligible if they have Low or Int-1
disease per IPSS. Patients may have received MDS-directed therapy (i.e. lenalidomide),
although patients with prior exposure to hypomethylating agents (e.g. 5-azacitidine or
decitabine) are not eligible.

3. The interval from prior treatment to time of study drug administration is at least 1
week (except for hydroxyurea or steroid therapy) with recovery from all prior
therapy-related toxicities

4. Age >/= 18 years old.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

6. Adequate liver function, as evidence by serum bilirubin range (except for patients with Gilbert's Disease) or an aspartate aminotransferase
(AST) or alanine aminotransferase (ALT) of investigator.

7. Serum creatinine (Cr) /=50 ml/min

8. Subjects of reproductive potential must agree to the use of acceptable contraceptive
methods for the duration of the time on study and a further 6 months after completion
of treatment. Women of childbearing potential must have a negative blood or urine
pregnancy test within 72 hours of start of treatment.

Exclusion Criteria:

1. Subjects with any prior exposure to the hypomethylating agents (5-azacitidine or
decitabine) are excluded.

2. Subjects with any prior exposure to JAK2 inhibitor therapy (i.e. ruxolitinib or prior
pacritinib therapy) are excluded.

3. Any prior or coexisting medical condition that in the investigator's judgment will
substantially increase the risk associated with the subject's participation in the
study.

4. Psychiatric disorders or altered mental status precluding understanding of the
informed consent process and/or completion of the necessary study procedures.

5. Active uncontrolled serious infection or sepsis at study enrollment. Patients
receiving antibiotics for infections that are under control may be included in the
study.

6. Gastrointestinal disorders that may significantly interfere with absorption of study
drug.

7. Subjects have received potent CYP3A inhibitors within 7 days prior to the initiation
of study treatment.

8. History of myocardial infarction, severe/unstable angina, or symptomatic congestive
heart failure (New York Heart Failure (NYHA) Class III or IV congestive heart failure)
within 6 months prior to study enrollment or Left ventricular ejection fraction (LVEF)
<50%

9. Impaired cardiac function including ongoing cardiac dysrhythmias of Grade > 2,
ejection fraction < 50%, atrial fibrillation of any grade, or QTc prolongation > 450
ms, or other factors that increase the risk of QT prolongation (i.e. family history of
long QT interval syndrome, hypokalemia defined as serum potassium < 3.0 mEq/L)

10. Diagnosis of other malignancies within the last 3 years other than curatively treated
non-melanoma skin cancer, carcinoma in situ of the cervix, organ-confined or treated
non-metastatic prostate cancer, in situ breast carcinoma after complete surgical
resection, or superficial transitional cell bladder carcinoma.

11. Known active Hepatitis A, B or C.

12. Known HIV seropositivity.

13. Women who are pregnant or lactating.