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Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (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: NCT02010645
Recruitment Status : Terminated (PI Request)
First Posted : December 13, 2013
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if eltrombopag given in combination with decitabine can help to control advanced MDS. The safety of this study drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Eltrombopag Drug: Decitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Eltrombopag in Combination With Decitabine in Subjects With Advanced Myelodysplastic Syndrome
Actual Study Start Date : March 2014
Actual Primary Completion Date : January 2, 2019
Actual Study Completion Date : January 2, 2019


Arm Intervention/treatment
Experimental: Eltrombopag + Decitabine

Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.

Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.

Drug: Eltrombopag
Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.
Other Name: Promacta

Drug: Decitabine
Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
Other Name: Dacogen




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 28 days ]
    The primary endpoint is the overall response rate (ORR) based on the IWG-2006 criteria, which includes complete remission (CR), partial remission (PR), and hematologic improvement (HI).



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 must be obtained prior to any study specific procedures.
  2. Subjects with a histologically confirmed diagnosis of MDS by FAB criteria, including both MDS and RAEB-T (AML with 20-30% blasts and multilineage dysplasia) and chronic myelomonocytic leukemia (CMML) with at least 10% bone marrow blasts by World Health Organization (WHO) classification are eligible.
  3. Advanced MDS by virtue of intermediate-2 or high-risk MDS by IPSS score, or high or very-high risk by IPSS-R.
  4. Platelet count </= 100 x 10^9/L at baseline
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  6. Adequate liver function, as evidenced by a serum bilirubin </= 2x the ULN (except for patients with a confirmed diagnosis of Gilbert's Disease) and an ALT or AST </= 3x the laboratory ULN.
  7. Serum creatinine </= 2.5x upper limit of normal
  8. Subjects must be >/= 18 years of age at the time of informed consent
  9. Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subject) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e. Pearl index < 1.0%) from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: - Complete abstinence from intercourse; - Intrauterine device (IUD); - Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); - Male partner is sterile prior to entry into the study and is the only partner of the female; - Systemic contraceptives (combined or progesterone only).

Exclusion Criteria:

  1. Subjects with any prior exposure to a thrombopoietin-receptor agonist
  2. Prior hypomethylating agent treatment for MDS
  3. Any prior or co-existing 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
  6. Clinically significant gastrointestinal disorders that may interfere with absorption of drug.
  7. History of arterial thrombosis (i.e. stroke) in the past year
  8. History of venous thrombosis currently requiring anti-coagulation therapy
  9. Unstable angina, congestive heart failure (New York Heart Association (NYHA) > Class II), uncontrolled hypertension (diastolic blood pressure > 100mmHg), or recent (within 1 year) myocardial infarction
  10. Subjects with a QTc > 480 msec (QTc > 510 msec for subjects with Bundle Branch Block) at baseline
  11. Pregnant or breast-feeding
  12. Subjects with known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), because eltrombopag is hepatically cleared, and underlying hepatic impairment may lead to an increased risk of hepatotoxicity. Eltrombopag has not been evaluated with combination antiretroviral regimens.
  13. Subjects with liver cirrhosis (as determined by the investigator)
  14. Subjects with hypersensitivity to study drugs or their excipients.

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): NCT02010645


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
GlaxoSmithKline
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: NCT02010645    
Other Study ID Numbers: 2013-0590
NCI-2014-01276 ( Registry Identifier: NCI CTRP )
First Posted: December 13, 2013    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020
Last Verified: December 2019

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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
Advanced Myelodysplastic Syndrome
MDS
Intermediate-2 Myelodysplastic Syndrome
High-Risk Myelodysplastic Syndrome
Chronic myelomonocytic leukemia
CMML
Eltrombopag
Promacta
Decitabine
Dacogen
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors