Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT01550185 |
Recruitment Status
:
Terminated
(Sponsor wanted study rewritten)
First Posted
: March 9, 2012
Last Update Posted
: April 6, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | March 7, 2012 | |||
First Posted Date ICMJE | March 9, 2012 | |||
Last Update Posted Date | April 6, 2016 | |||
Study Start Date ICMJE | May 2012 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
MTD and tolerability of eltrombopag olamine in patients with AML [ Time Frame: First 15 days of eltrombopag olamine ] Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
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Change History | Complete list of historical versions of study NCT01550185 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Platelet count recovery to >= 100 x 10^9/L [ Time Frame: Up to 9 weeks ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia | |||
Official Title ICMJE | Phase I Dose-Finding Study of Eltrombopag Following High Dose Cytarabine and Mitoxantrone in Relapsed/Refractory Patients With Acute Myeloid Leukemia | |||
Brief Summary | The purpose of this study is to find out the highest safe dose and examine the side effects and effectiveness of eltrombopag olamine in patients with acute myeloid leukemia (AML) treated with chemotherapy that have not responded to previous therapy or have suffered a relapse | |||
Detailed Description | PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and examine the tolerability of daily oral eltrombopag (eltrombopag olamine) (14 days +/- 2 days after initiation of cytarabine) in patients receiving high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemia patients with hypoplastic bone marrow 14 days +/- 2 days from initiation of cytarabine. II. To examine platelet count recovery to >= 100 x 10^9/L when eltrombopag is administered following high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemic patients. OUTLINE: This is a dose-escalation study. Patients receive eltrombopag olamine orally (PO) once daily (QD) from day 1 up to day 62. Treatment continues for up to 9 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Experimental: Treatment (eltrombopag olamine)
Patients receive eltrombopag olamine PO QD from day 1 up to day 62. Treatment continues for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE |
36 | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01550185 | |||
Other Study ID Numbers ICMJE | I 206111 NCI-2012-00215 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Roswell Park Cancer Institute | |||
Study Sponsor ICMJE | Roswell Park Cancer Institute | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Roswell Park Cancer Institute | |||
Verification Date | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |