Trial Outcomes & Findings for Panobinostat in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (NCT NCT00723203)
NCT ID: NCT00723203
Last Updated: 2014-09-09
Results Overview
Morphologic CR: morphologic leukemia-free state with absolute neutrophil count \> 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (\<1000/uL) and/or thrombocytopenia (\<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value \> 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 6 cycles of treatment, up to 24 weeks.
Results posted on
2014-09-09
Participant Flow
Participant milestones
| Measure |
Treatment (Panobinostat)
Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Panobinostat)
Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Panobinostat in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Panobinostat)
n=16 Participants
Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 cycles of treatment, up to 24 weeks.Population: Three patients of the 16 accrued were not included in the analysis for response per protocol due to patient refusal for alternative treatment prior to completing the first cycle of treatment.
Morphologic CR: morphologic leukemia-free state with absolute neutrophil count \> 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (\<1000/uL) and/or thrombocytopenia (\<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value \> 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.
Outcome measures
| Measure |
Treatment (Panobinostat)
n=13 Participants
Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples
|
|---|---|
|
Hematological Response Rate
|
0 percentage of responding participants
|
Adverse Events
Treatment (Panobinostat)
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Panobinostat)
n=16 participants at risk
Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
31.2%
5/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
6.2%
1/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Disease progression
|
31.2%
5/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Fever
|
12.5%
2/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Infections and infestations
Sepsis
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
6.2%
1/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Facial nerve disorder
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Renal and urinary disorders
Renal failure
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
2/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
Other adverse events
| Measure |
Treatment (Panobinostat)
n=16 participants at risk
Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
gene expression analysis: Day 1 and day 28 samples
reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples
laboratory biomarker analysis: Day 1 and day 28 samples
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
16/16 • Number of events 34 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Arrhythmia
|
25.0%
4/16 • Number of events 8 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.2%
1/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Cardiac disorder
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Nodal arrhythmia
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Palpitations
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Premature ventricular contractions
|
18.8%
3/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Sinus arrhythmia
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
4/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
68.8%
11/16 • Number of events 17 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Ventricular fibrillation
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Ear and labyrinth disorders
External ear inflammation
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Eye disorders
Cataract
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Eye disorders
Eye disorder
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Eye disorders
Vision blurred
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
5/16 • Number of events 9 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
62.5%
10/16 • Number of events 14 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
3/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.2%
1/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Lip pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Nausea
|
62.5%
10/16 • Number of events 13 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
25.0%
4/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Stomach pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Chest pain
|
31.2%
5/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Chills
|
43.8%
7/16 • Number of events 8 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Edema limbs
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Fatigue
|
93.8%
15/16 • Number of events 28 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Fever
|
37.5%
6/16 • Number of events 9 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Injection site reaction
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Localized edema
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
General disorders
Pain
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Immune system disorders
Hypersensitivity
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
2/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
43.8%
7/16 • Number of events 10 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
62.5%
10/16 • Number of events 20 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
6/16 • Number of events 7 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Bilirubin increased
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Creatinine increased
|
31.2%
5/16 • Number of events 9 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Fibrinogen decreased
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Laboratory test abnormal
|
6.2%
1/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Leukocyte count decreased
|
56.2%
9/16 • Number of events 22 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Lymphocyte count decreased
|
37.5%
6/16 • Number of events 15 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Neutrophil count decreased
|
62.5%
10/16 • Number of events 23 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Platelet count decreased
|
81.2%
13/16 • Number of events 36 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Serum cholesterol increased
|
6.2%
1/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Investigations
Weight loss
|
25.0%
4/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Alkalosis
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
43.8%
7/16 • Number of events 10 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
37.5%
6/16 • Number of events 10 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
68.8%
11/16 • Number of events 20 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
31.2%
5/16 • Number of events 7 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
87.5%
14/16 • Number of events 24 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
62.5%
10/16 • Number of events 21 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
43.8%
7/16 • Number of events 14 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
37.5%
6/16 • Number of events 9 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
37.5%
6/16 • Number of events 15 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
25.0%
4/16 • Number of events 6 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
62.5%
10/16 • Number of events 15 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
50.0%
8/16 • Number of events 18 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
12.5%
2/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
2/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Depressed level of consciousness
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Dizziness
|
43.8%
7/16 • Number of events 7 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Neurological disorder NOS
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Taste alteration
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
6.2%
1/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Psychiatric disorders
Anxiety
|
18.8%
3/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Renal and urinary disorders
Protein urine positive
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
6/16 • Number of events 9 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
6/16 • Number of events 6 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
12.5%
2/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.8%
3/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
2/16 • Number of events 3 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
18.8%
3/16 • Number of events 4 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
18.8%
3/16 • Number of events 5 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 2 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
|
Vascular disorders
Hypotension
|
25.0%
4/16 • Number of events 7 • Adverse events occurred over a time period of 1 year and 9 months.
"Other" adverse events includes all grades and attributions to treatment that are not included in "Serious" adverse events.
|
Additional Information
Paul Frankel, Ph.D.
City of Hope National Medical Center
Phone: (626)359-8111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place