Trial Outcomes & Findings for UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas (NCT NCT00082017)
NCT ID: NCT00082017
Last Updated: 2017-05-15
Results Overview
Clinical Response Rate is the percentage of participants with a response assessed by the International Workshop to Standardize Response Criteria. Complete response (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (CRu) is per CR criteria except that if a residual node is \>1.5cm, it must have regressed by \>75%. Partial response (PR) is no increase in size of nodes, liver or spleen. Progressive disease (PD) is a greater than or equal to 50% increase from nadir. Details re: response criteria, see the protocol link module
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
74.5 months
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days
Cohort 1 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2. Repeat cycles every 28 days.
|
UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days
Cohort 2 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas
Baseline characteristics by cohort
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1&2
n=20 Participants
Cohort 1 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 28 days.
Cohort 2 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
35.29 years
STANDARD_DEVIATION 18.89 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 74.5 monthsClinical Response Rate is the percentage of participants with a response assessed by the International Workshop to Standardize Response Criteria. Complete response (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (CRu) is per CR criteria except that if a residual node is \>1.5cm, it must have regressed by \>75%. Partial response (PR) is no increase in size of nodes, liver or spleen. Progressive disease (PD) is a greater than or equal to 50% increase from nadir. Details re: response criteria, see the protocol link module
Outcome measures
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days
n=11 Participants
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2. Repeat cycles every 28 days.
|
UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days
n=9 Participants
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|---|
|
Clinical Response Rate
Complete response
|
18 Percentage of participants
|
0 Percentage of participants
|
|
Clinical Response Rate
Partial response
|
9 Percentage of participants
|
0 Percentage of participants
|
|
Clinical Response Rate
Stable disease
|
9 Percentage of participants
|
33 Percentage of participants
|
|
Clinical Response Rate
Complete response unconfirmed
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Clinical Response Rate
Progressive disease
|
55 Percentage of participants
|
45 Percentage of participants
|
|
Clinical Response Rate
Not evaluable
|
9 Percentage of participants
|
22 Percentage of participants
|
PRIMARY outcome
Timeframe: 3.6 monthsPFS is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression is assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as a ≥50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for partial response's or non-responders or appearance of any new lesion during or at the end of therapy.
Outcome measures
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days
n=11 Participants
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2. Repeat cycles every 28 days.
|
UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days
n=8 Participants
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
0.8 months
Interval 0.2 to 2.2
|
0.8 months
Interval 0.4 to 3.6
|
PRIMARY outcome
Timeframe: 55 monthsOS is defined as the date of on-study to the date of death from any cause or last follow up.
Outcome measures
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days
n=11 Participants
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2. Repeat cycles every 28 days.
|
UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days
n=8 Participants
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Confidence interval was not calculated and median was not reached because over half of the participants were alive.
|
5.2 months
Interval 0.7 to 55.0
|
SECONDARY outcome
Timeframe: 76 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days
n=20 Participants
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2. Repeat cycles every 28 days.
|
UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
19 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3-5 after drug administrationPopulation: This outcome measure was not done because data were insufficient to assess for possible effects on soluble TAC (CD25) levels.
Soluble TAC (CD25) levels will be assessed in patients with anaplastic large cell lymphoma.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3-5 after drug administrationPopulation: This outcome measure was not done because there were inadequate samples to evaluate mature T cell lymphoma malignant cells by cDNA microarray.
Mature T-cells will be analyzed to identify gene expression changes that correlate with loss of a tumor suppressor gene in a human melanoma cell line.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3-5 after drug administrationPopulation: This outcome measure was not done because data were insufficient to assess for possible effects of UCN-01 on ALK expression.
Gene expression patterns in participants ALK positive tumors will be assessed.
Outcome measures
Outcome data not reported
Adverse Events
UCN-01 for T-cell Lymphomas - Cohort 1&2
Serious events: 19 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1&2
n=20 participants at risk
Cohort 1 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 28 days.
Cohort 2 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
6/20 • Number of events 9 • 77 months
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
5/20 • Number of events 5 • 77 months
|
|
Blood and lymphatic system disorders
Anemia
|
55.0%
11/20 • Number of events 21 • 77 months
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
4/20 • Number of events 5 • 77 months
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Infections and infestations
Arteritis infective
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Aspartate aminotransferase increased
|
45.0%
9/20 • Number of events 12 • 77 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Blood bilirubin increased
|
40.0%
8/20 • Number of events 8 • 77 months
|
|
Cardiac disorders
Cardiac disorders-Other, specify
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
4/20 • Number of events 4 • 77 months
|
|
Investigations
CPK increased
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Creatinine increased
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 3 • 77 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
General disorders
Fatigue
|
35.0%
7/20 • Number of events 8 • 77 months
|
|
General disorders
Fever
|
15.0%
3/20 • Number of events 3 • 77 months
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • Number of events 12 • 77 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
8/20 • Number of events 22 • 77 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
35.0%
7/20 • Number of events 8 • 77 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.0%
3/20 • Number of events 4 • 77 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
2/20 • Number of events 6 • 77 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
4/20 • Number of events 4 • 77 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.0%
3/20 • Number of events 5 • 77 months
|
|
Vascular disorders
Hypotension
|
15.0%
3/20 • Number of events 4 • 77 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Lipase increased
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Lymphocyte count decreased
|
35.0%
7/20 • Number of events 14 • 77 months
|
|
Gastrointestinal disorders
Mucositis oral
|
15.0%
3/20 • Number of events 3 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Number of events 10 • 77 months
|
|
Investigations
Neutrophil count decreased
|
30.0%
6/20 • Number of events 12 • 77 months
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Cardiac disorders
Pericarditis
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Platelet count decreased
|
40.0%
8/20 • Number of events 9 • 77 months
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify (dysuria)
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Serum amylase increased
|
10.0%
2/20 • Number of events 3 • 77 months
|
|
Cardiac disorders
Sinus tachycardia
|
15.0%
3/20 • Number of events 4 • 77 months
|
|
Infections and infestations
Small intestine infection
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Renal and urinary disorders
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
8/20 • Number of events 18 • 77 months
|
|
Investigations
Weight loss
|
5.0%
1/20 • Number of events 3 • 77 months
|
|
Investigations
White blood cell decreased
|
40.0%
8/20 • Number of events 13 • 77 months
|
|
General disorders
Death (hypercalcemia)
|
5.0%
1/20 • Number of events 1 • 77 months
|
Other adverse events
| Measure |
UCN-01 for T-cell Lymphomas - Cohort 1&2
n=20 participants at risk
Cohort 1 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 28 days.
Cohort 2 Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2
Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
20.0%
4/20 • Number of events 5 • 77 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
15.0%
3/20 • Number of events 6 • 77 months
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • Number of events 6 • 77 months
|
|
Investigations
Alkaline phosphatase increased
|
15.0%
3/20 • Number of events 3 • 77 months
|
|
Immune system disorders
Allergic rhinitis
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Blood and lymphatic system disorders
Anemia
|
15.0%
3/20 • Number of events 3 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
4/20 • Number of events 8 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Number of events 6 • 77 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
General disorders
Chills
|
25.0%
5/20 • Number of events 7 • 77 months
|
|
Gastrointestinal disorders
Colonic perforation
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Investigations
Creatinine increased
|
15.0%
3/20 • Number of events 3 • 77 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • Number of events 4 • 77 months
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-Other, specify (fullness-R ear)
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
General disorders
Edema limbs
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
General disorders
Edema trunk
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Infections and infestations
Enterocolitis infectious
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
GGT increased
|
10.0%
2/20 • Number of events 3 • 77 months
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 3 • 77 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders-Other, specify (hyperbilirubinemia)
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
15.0%
3/20 • Number of events 3 • 77 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Investigations
Hypermagnesemia
|
20.0%
4/20 • Number of events 4 • 77 months
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.0%
3/20 • Number of events 3 • 77 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
10/20 • Number of events 12 • 77 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
6/20 • Number of events 11 • 77 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.0%
8/20 • Number of events 13 • 77 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
45.0%
9/20 • Number of events 20 • 77 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
40.0%
8/20 • Number of events 12 • 77 months
|
|
Vascular disorders
Hypotension
|
25.0%
5/20 • Number of events 6 • 77 months
|
|
General disorders
Hypothermia
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Infections and infestations
Infections and infestations - Other (Infection with normal ANC or grade 1 or 2 neutrophils: Blood)
|
20.0%
4/20 • Number of events 4 • 77 months
|
|
General disorders
Injection site reaction
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Investigations
INR increased
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Investigations-Other, specify
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Neutrophil count decreased
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
General disorders
Pain
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Cardiac disorders
Pericardial effusion
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 3 • 77 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Vascular disorders
Phlebitis
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Investigations
Platelet count decreased
|
15.0%
3/20 • Number of events 5 • 77 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • Number of events 4 • 77 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 2 • 77 months
|
|
Nervous system disorders
Seizure
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Serum amylase increased
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
2/20 • Number of events 4 • 77 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other, specify (hives)
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Renal and urinary disorders
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 3 • 77 months
|
|
Investigations
Weight gain
|
5.0%
1/20 • Number of events 1 • 77 months
|
|
Investigations
Weight loss
|
5.0%
1/20 • Number of events 7 • 77 months
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • Number of events 2 • 77 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 2 • 77 months
|
Additional Information
Wyndham Wilson, M.D.
National Cancer Institute, National Institues of Health
Phone: 301-435-2415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place