Trial Outcomes & Findings for Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes (NCT NCT00382200)
NCT ID: NCT00382200
Last Updated: 2024-05-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-05-20
Participant Flow
Participant milestones
| Measure |
Phase I: Tretinoin 45 mg/m2/Day
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 65 mg/m2/Day
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 85 mg/m2/Day
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase II: MTD Tretinoin 65 mg/m2/Day
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
14
|
7
|
28
|
|
Overall Study
COMPLETED
|
5
|
14
|
7
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Decitabine and All-Trans Retonoic Acid (Tretinoin)
n=5 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 65 mg/m2/Day
n=14 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 85 mg/m2/Day
n=7 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase II: MTD Tretinoin 65 mg/m2/Day
n=28 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
66.5 years
n=7 Participants
|
64 years
n=5 Participants
|
66.5 years
n=4 Participants
|
68 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearOutcome measures
| Measure |
Phase I: Tretinoin 45 mg/m2/Day
n=5 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 65 mg/m2/Day
n=14 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 85 mg/m2/Day
n=7 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase II: MTD Tretinoin 65 mg/m2/Day
n=28 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
|---|---|---|---|---|
|
Number of Participants Evaluated for Hematologic and Nonhematologic Toxicities as Measured by NCI CTC v2.0
|
5 Participants
|
14 Participants
|
7 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearOutcome measures
| Measure |
Phase I: Tretinoin 45 mg/m2/Day
n=28 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 65 mg/m2/Day
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 85 mg/m2/Day
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase II: MTD Tretinoin 65 mg/m2/Day
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
|---|---|---|---|---|
|
Maximum Tolerated Dose of Tretinoin When Administered With Decitabine as Determined by NCI CTC v2.0 (Phase II)
|
65 mg/m^2/day of tretinoin
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 1 yearOverall Response Rate is defined as Complete Response + Partial Response
Outcome measures
| Measure |
Phase I: Tretinoin 45 mg/m2/Day
n=5 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 65 mg/m2/Day
n=14 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 85 mg/m2/Day
n=7 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase II: MTD Tretinoin 65 mg/m2/Day
n=28 Participants
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
|---|---|---|---|---|
|
Overall Response Rate
Participants with either Complete or Partial Response
|
4 Participants
|
6 Participants
|
2 Participants
|
13 Participants
|
|
Overall Response Rate
Participants Evaluated without Complete or Partial Response
|
0 Participants
|
4 Participants
|
1 Participants
|
11 Participants
|
|
Overall Response Rate
Not Evaluable for Response
|
1 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: After each cyclePopulation: N/A data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After each cyclePopulation: N/A data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After each cyclePopulation: N/A data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After each cyclePopulation: N/A data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After each cyclePopulation: N/A data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After each cyclePopulation: N/A data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Phase I: Tretinoin 45 mg/m2/Day
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase I: Tretinoin 65 mg/m2/Day
Serious events: 9 serious events
Other events: 14 other events
Deaths: 2 deaths
Phase I: Tretinoin 85 mg/m2/Day
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase II: MTD Tretinoin 65 mg/m2/Day
Serious events: 21 serious events
Other events: 28 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Phase I: Tretinoin 45 mg/m2/Day
n=5 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 65 mg/m2/Day
n=14 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 85 mg/m2/Day
n=7 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase II: MTD Tretinoin 65 mg/m2/Day
n=28 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Investigations
Bilirubin
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Blood and lymphatic system disorders
Blood, bone marrow, other
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Cardiac disorders
Cardiovascular, Arrhythmia, other
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Cardiac disorders
Cardiovascular, other
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Cardiac disorders
Chest pain
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Investigations
Creatinine
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Derm, skin other
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Reproductive system and breast disorders
Dyspnea
|
20.0%
1/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
General disorders
Edema
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
General disorders
Fatigue
|
20.0%
1/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
40.0%
2/5 • up to 1 year
|
42.9%
6/14 • up to 1 year
|
42.9%
3/7 • up to 1 year
|
35.7%
10/28 • up to 1 year
|
|
General disorders
Fever
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Blood and lymphatic system disorders
Infection with febrile neutropenia
|
40.0%
2/5 • up to 1 year
|
21.4%
3/14 • up to 1 year
|
28.6%
2/7 • up to 1 year
|
28.6%
8/28 • up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Investigations
Neutrophils
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
General disorders
Pain
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
28.6%
2/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Gastrointestinal disorders
Rectal pain
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Infections and infestations
Wound, infectious
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • up to 1 year
|
14.3%
2/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
Other adverse events
| Measure |
Phase I: Tretinoin 45 mg/m2/Day
n=5 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 65 mg/m2/Day
n=14 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase I: Tretinoin 85 mg/m2/Day
n=7 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
Phase II: MTD Tretinoin 65 mg/m2/Day
n=28 participants at risk
Decitabine and All-Trans Retonoic Acid (Tretinoin)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/5 • up to 1 year
|
35.7%
5/14 • up to 1 year
|
28.6%
2/7 • up to 1 year
|
35.7%
10/28 • up to 1 year
|
|
Infections and infestations
Infection w/out neutropenia
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
14.3%
4/28 • up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
General disorders
Fatigue
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
General disorders
Fever
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hypermagnemesia
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
14.3%
4/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
10.7%
3/28 • up to 1 year
|
|
Investigations
PTT
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
General disorders
Pain
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Investigations
PT
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
17.9%
5/28 • up to 1 year
|
|
Investigations
Amylase
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Investigations
Lipase
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Investigations
Blood bicarbonate
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • up to 1 year
|
14.3%
2/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
10.7%
3/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • up to 1 year
|
28.6%
4/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Vascular disorders
Hypotention
|
0.00%
0/5 • up to 1 year
|
14.3%
2/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Gastrointestinal disorders
GI, other
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Investigations
Fibrinogen
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Investigations
Hypernatremia
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Investigations
Hypoglycemia
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Investigations
Platelets
|
60.0%
3/5 • up to 1 year
|
50.0%
7/14 • up to 1 year
|
57.1%
4/7 • up to 1 year
|
100.0%
28/28 • up to 1 year
|
|
Investigations
Neutrophils
|
80.0%
4/5 • up to 1 year
|
78.6%
11/14 • up to 1 year
|
85.7%
6/7 • up to 1 year
|
85.7%
24/28 • up to 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
28.6%
2/7 • up to 1 year
|
39.3%
11/28 • up to 1 year
|
|
Investigations
Leukocytes
|
100.0%
5/5 • up to 1 year
|
92.9%
13/14 • up to 1 year
|
100.0%
7/7 • up to 1 year
|
100.0%
28/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • up to 1 year
|
28.6%
4/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
42.9%
12/28 • up to 1 year
|
|
Investigations
ALT
|
0.00%
0/5 • up to 1 year
|
21.4%
3/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
10.7%
3/28 • up to 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
28.6%
2/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Investigations
AST
|
0.00%
0/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
14.3%
4/28 • up to 1 year
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
60.0%
3/5 • up to 1 year
|
35.7%
5/14 • up to 1 year
|
42.9%
3/7 • up to 1 year
|
32.1%
9/28 • up to 1 year
|
|
Investigations
Alkaline Phosphatase
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Investigations
Lymphopenia
|
40.0%
2/5 • up to 1 year
|
78.6%
11/14 • up to 1 year
|
85.7%
6/7 • up to 1 year
|
78.6%
22/28 • up to 1 year
|
|
Investigations
Bilirubin
|
20.0%
1/5 • up to 1 year
|
7.1%
1/14 • up to 1 year
|
28.6%
2/7 • up to 1 year
|
17.9%
5/28 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash, desquamation
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
3.6%
1/28 • up to 1 year
|
|
Investigations
Creatinine
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Infections and infestations
Infection with grade 3/4 neutr
|
60.0%
3/5 • up to 1 year
|
28.6%
4/14 • up to 1 year
|
28.6%
2/7 • up to 1 year
|
14.3%
4/28 • up to 1 year
|
|
Skin and subcutaneous tissue disorders
Derm, skin other
|
0.00%
0/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • up to 1 year
|
14.3%
2/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
7.1%
2/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • up to 1 year
|
14.3%
2/14 • up to 1 year
|
14.3%
1/7 • up to 1 year
|
35.7%
10/28 • up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • up to 1 year
|
0.00%
0/14 • up to 1 year
|
0.00%
0/7 • up to 1 year
|
0.00%
0/28 • up to 1 year
|
Additional Information
Dr. Raajit Rampal, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3746
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place