Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
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ClinicalTrials.gov Identifier: NCT02249949 |
Recruitment Status :
Active, not recruiting
First Posted : September 26, 2014
Results First Posted : June 27, 2019
Last Update Posted : July 24, 2020
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Sponsor:
Alliance for Clinical Trials in Oncology
Collaborators:
National Cancer Institute (NCI)
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Liposarcoma |
Intervention |
Drug: efatutazone |
Enrollment | 15 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | A protocol amendment (Update #02) removed the option for patients to be randomized to Placebo; the study went from being a randomized study to a single arm study. The discrepancy in the number of patients who 'Started' the study and the Protocol Enrollment number is due to there being 2 patients randomized to Placebo prior to Update #02. |
Arm/Group Title | Efatutazone Dihydrochloride |
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Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Period Title: Overall Study | |
Started | 13 |
Completed | 11 |
Not Completed | 2 |
Reason Not Completed | |
Cancelled prior to treatment | 2 |
Baseline Characteristics
Arm/Group Title | Efatutazone Dihydrochloride | |
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Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | |
Overall Number of Baseline Participants | 11 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 11 participants | |
51.4 (17.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | |
Female |
4 36.4%
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Male |
7 63.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | |
Hispanic or Latino |
2 18.2%
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Not Hispanic or Latino |
9 81.8%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
1 9.1%
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White |
8 72.7%
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More than one race |
0 0.0%
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Unknown or Not Reported |
2 18.2%
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ECOG Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | |
0 |
6 54.5%
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1 |
5 45.5%
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[1]
Measure Description: Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Michael J. Pishvaian, MD, PhD |
Organization: | Georgetown University |
Phone: | 202-444-2144 |
EMail: | pishvaim@georgetown.edu |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT02249949 |
Other Study ID Numbers: |
A091202 NCI-2014-01028 ( Registry Identifier: NCI Clinical Trials Reporting Program ) |
First Submitted: | September 24, 2014 |
First Posted: | September 26, 2014 |
Results First Submitted: | June 10, 2019 |
Results First Posted: | June 27, 2019 |
Last Update Posted: | July 24, 2020 |