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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469415
Recruitment Status : Terminated (FDA Clinical Hold)
First Posted : June 11, 2015
Results First Posted : April 23, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Pacritinib Drug: 5-azacitidine Drug: Decitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : June 3, 2017
Actual Study Completion Date : June 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pacritinib + Azacitidine or Decitabine

Part 1: Pacritinib 200 mg taken by mouth twice daily. Study cycles administered every 28 days.

Part 2: After 4 cycles of treatment, Pacritinib combined with 5-azacitidine or Decitabine. Pacritinib decreased to 200 mg in morning and 100 mg in evening for first cycle of combined therapy with Pacritinib increased to 200 mg twice a day on subsequent cycles of combined therapy. Those with disease progression prior to 4 cycles of Pacritinib may initiate Pacritinib + HMA study portion prior to completion of 4 cycles. Starting dose of either 5-azacitidine 75 mg/m2 by vein (IV) or Decitabine 20 mg/m2 IVon Days 1 - 5 of Cycles 5 and beyond.

Drug: Pacritinib

Part 1: Pacritinib 200 mg taken by mouth twice daily.

Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined therapy.


Drug: 5-azacitidine
Part 2 Starting Dose of 5-azacitidine: 75 mg/m2 by vein on Days 1 - 5 of Cycles 5 and beyond.
Other Names:
  • Azacitidine
  • 5-azacytidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
  • Azacytidine

Drug: Decitabine
Part 2 Starting Dose of Decitabine: 20 mg/m2 by vein on on Days 1 - 7 of Cycles 5 and beyond.
Other Name: Dacogen




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 28 days ]
    The primary efficacy outcome of both parts is the overall response rate (ORR) based mainly on hematologic improvement defined by (International Working Group) IWG-2006 criteria, and which also includes complete remission (CR), partial remission (PR) and marrow complete remission.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 </= 2x the laboratory normal range (except for patients with Gilbert's Disease) or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) of </= 2.5x the upper limit of normal (ULN) or </= 5x ULN if hepatic disease involvement is present as determined by the investigator.
  7. Serum creatinine (Cr) </= 2x ULN or 24-hour creatinine clearance >/=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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469415


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
CTI BioPharma
Investigators
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Principal Investigator: Courtney DiNardo, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02469415    
Other Study ID Numbers: 2013-0224
NCI-2015-01306 ( Registry Identifier: NCI CTRP )
First Posted: June 11, 2015    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: October 16, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Myelodysplastic syndromes
MDS
Lower-risk
Pacritinib
5-azacitidine
Azacitidine
5-azacytidine
Vidaza
5-AZC
AZA-CR
Ladakamycin
NSC-102816
Azacytidine
Decitabine
Dacogen
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors