Trial Outcomes & Findings for Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS) (NCT NCT02010645)
NCT ID: NCT02010645
Last Updated: 2020-01-02
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
28 days
Results posted on
2020-01-02
Participant Flow
Recruitment period: March 2014 to February 2015
Participant milestones
| Measure |
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.
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.
Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
Eltrombopag + Decitabine
n=6 Participants
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.
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.
Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: One participant was not evaluable for response.
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).
Outcome measures
| Measure |
Eltrombopag + Decitabine
n=5 Participants
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.
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.
Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
|
|---|---|
|
Overall Response Rate (ORR)
|
1 Participants
|
Adverse Events
Eltrombopag + Decitabine
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Eltrombopag + Decitabine
n=6 participants at risk
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.
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.
Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
|
|---|---|
|
Infections and infestations
Lung Infection
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Infections and infestations
Neutropenic Fever
|
33.3%
2/6 • Number of events 2 • 3 years and 9 months
|
|
General disorders
Flank Pain
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
General disorders
Fall
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Gastrointestinal disorders
Retroperitoneal Hemorrhage
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Cardiac disorders
Cardiac Arrest
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
Other adverse events
| Measure |
Eltrombopag + Decitabine
n=6 participants at risk
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.
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.
Decitabine: Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
|
|---|---|
|
General disorders
Back Pain
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Eye disorders
Blurred Vision
|
33.3%
2/6 • Number of events 3 • 3 years and 9 months
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 3 • 3 years and 9 months
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • 3 years and 9 months
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 3 • 3 years and 9 months
|
|
Gastrointestinal disorders
Oral Mucositis
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • 3 years and 9 months
|
|
Investigations
Neutropenia
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Erythematous Rash
|
16.7%
1/6 • Number of events 1 • 3 years and 9 months
|
Additional Information
Courtney DiNardo, MD/Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-1141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place