Trial Outcomes & Findings for Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment (NCT NCT00416351)
NCT ID: NCT00416351
Last Updated: 2022-05-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
2 years
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
4 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
8 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
13.2 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
20 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
28 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
4
|
17
|
4
|
|
Overall Study
COMPLETED
|
1
|
3
|
4
|
17
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Baseline characteristics by cohort
| Measure |
4 mg/m2/Day Clofarabine
n=1 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
8 mg/m2/Day Clofarabine
n=3 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
13.2 mg/m2/Day Clofarabine
n=4 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
20 mg/m2/Day Clofarabine
n=17 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
28 mg/m2/Day Clofarabine
n=4 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
65.3 years
n=4 Participants
|
58 years
n=27 Participants
|
54.1 years
n=483 Participants
|
54.5 years
n=36 Participants
|
59 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
15 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
28 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
29 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Clofarabine
n=29 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
clofarabine
|
8 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 8 mg/m2/day and will be escalated to higher dose levels.
|
13.2 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 13.2 mg/m2/day and will be escalated to higher dose levels.
|
20 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels.
|
28 mg/m2/Day Clofarabine
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose
|
20 mg/m2 of clofarabine
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Evaluable participants with Non-Hodgkin's Lymphoma
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
Outcome measures
| Measure |
Clofarabine
n=1 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
clofarabine
|
8 mg/m2/Day Clofarabine
n=3 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 8 mg/m2/day and will be escalated to higher dose levels.
|
13.2 mg/m2/Day Clofarabine
n=4 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 13.2 mg/m2/day and will be escalated to higher dose levels.
|
20 mg/m2/Day Clofarabine
n=17 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels.
|
28 mg/m2/Day Clofarabine
n=4 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels.
|
|---|---|---|---|---|---|
|
Response Rate for Participants With Non-Hodgkin's Lymphoma
Complete Response
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate for Participants With Non-Hodgkin's Lymphoma
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate for Participants With Non-Hodgkin's Lymphoma
Stable Disease (SD)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Response Rate for Participants With Non-Hodgkin's Lymphoma
Progression of Disease (POD)
|
1 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
|
Response Rate for Participants With Non-Hodgkin's Lymphoma
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate for Participants With Non-Hodgkin's Lymphoma
Stable Disease/Progression of Disease (SD/POD)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsToxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
Outcome measures
| Measure |
Clofarabine
n=1 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
clofarabine
|
8 mg/m2/Day Clofarabine
n=3 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 8 mg/m2/day and will be escalated to higher dose levels.
|
13.2 mg/m2/Day Clofarabine
n=4 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 13.2 mg/m2/day and will be escalated to higher dose levels.
|
20 mg/m2/Day Clofarabine
n=17 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels.
|
28 mg/m2/Day Clofarabine
n=4 Participants
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels.
|
|---|---|---|---|---|---|
|
Participants Evaluated for Toxicity
|
1 Participants
|
3 Participants
|
4 Participants
|
17 Participants
|
4 Participants
|
Adverse Events
4 mg/m2/Day Clofarabine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
8 mg/m2/Day Clofarabine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
13.2 mg/m2/Day Clofarabine
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
20 mg/m2/Day Clofarabine
Serious events: 13 serious events
Other events: 17 other events
Deaths: 12 deaths
28 mg/m2/Day Clofarabine
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
4 mg/m2/Day Clofarabine
n=1 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
8 mg/m2/Day Clofarabine
n=3 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
13.2 mg/m2/Day Clofarabine
n=4 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
20 mg/m2/Day Clofarabine
n=17 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
28 mg/m2/Day Clofarabine
n=4 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Calcium, high (hypercalcemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Creatinine
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • 2 years
|
33.3%
1/3 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Bronchitis NOS
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Joint
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Cellulitis(skin)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Pneumonia(lung)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Blood
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Infections and infestations
Infection, other
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
35.3%
6/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Eye disorders
Ocular/Visual - Other (specify)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Odor (patient odor)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
General disorders
Pain - Other (specify)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Platelets
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malig)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
General disorders
Rigors/chills
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Uric acid, high (hyperuricemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
Other adverse events
| Measure |
4 mg/m2/Day Clofarabine
n=1 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
8 mg/m2/Day Clofarabine
n=3 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
13.2 mg/m2/Day Clofarabine
n=4 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
20 mg/m2/Day Clofarabine
n=17 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
28 mg/m2/Day Clofarabine
n=4 participants at risk
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
1/1 • 2 years
|
66.7%
2/3 • 2 years
|
50.0%
2/4 • 2 years
|
11.8%
2/17 • 2 years
|
75.0%
3/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
75.0%
3/4 • 2 years
|
|
Investigations
Hemoglobin
|
0.00%
0/1 • 2 years
|
66.7%
2/3 • 2 years
|
25.0%
1/4 • 2 years
|
58.8%
10/17 • 2 years
|
75.0%
3/4 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
General disorders
Pain - Other (specify)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
General disorders
Constipation
|
0.00%
0/1 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Investigations
Creatinine
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Infection, other
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Leukocytes (total WBC)
|
0.00%
0/1 • 2 years
|
100.0%
3/3 • 2 years
|
50.0%
2/4 • 2 years
|
58.8%
10/17 • 2 years
|
75.0%
3/4 • 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/1 • 2 years
|
100.0%
3/3 • 2 years
|
50.0%
2/4 • 2 years
|
52.9%
9/17 • 2 years
|
75.0%
3/4 • 2 years
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Platelets
|
0.00%
0/1 • 2 years
|
66.7%
2/3 • 2 years
|
50.0%
2/4 • 2 years
|
58.8%
10/17 • 2 years
|
100.0%
4/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malig)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
100.0%
4/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulm/upp respiratory - Other (spec)
|
0.00%
0/1 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
50.0%
2/4 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Weight loss
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Investigations
ALT, SGPT
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Metabolism and nutrition disorders
AST, SGOT
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Calcium, high (hypercalcemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
11.8%
2/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
General disorders
Edema: Limb
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • 2 years
|
33.3%
1/3 • 2 years
|
25.0%
1/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
17.6%
3/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Skin (cellulites)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
INR
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Investigations
Lymphopenia
|
100.0%
1/1 • 2 years
|
66.7%
2/3 • 2 years
|
50.0%
2/4 • 2 years
|
64.7%
11/17 • 2 years
|
75.0%
3/4 • 2 years
|
|
Metabolism and nutrition disorders
Magnesium, high (hypermagnesemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
0.00%
0/1 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
0.00%
0/1 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/4 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
50.0%
2/4 • 2 years
|
17.6%
3/17 • 2 years
|
25.0%
1/4 • 2 years
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
23.5%
4/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/4 • 2 years
|
|
General disorders
Rigors/chills
|
0.00%
0/1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/4 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/4 • 2 years
|
Additional Information
Dr. Steven Horowitz MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-2680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place