Trial Outcomes & Findings for AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer (NCT NCT00427973)
NCT ID: NCT00427973
Last Updated: 2016-10-31
Results Overview
Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first. This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
3 months
Results posted on
2016-10-31
Participant Flow
The study enrolled the targeted 17 patients for the first stage between May 2009 and January 2010. Patients were recruited in the outpatient clinics.
Participant milestones
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily.
Patients will receive AZD2171 by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer
Baseline characteristics by cohort
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
n=17 Participants
Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group
|
1 units on a scale
n=5 Participants
|
|
Cancer Of Liver Italian Program (CLIP)
|
2 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The number of patients who were progression free at 3 months was determined. 13 of 17 patients (77%) were progression free at 3 months.
Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first. This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%.
Outcome measures
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
n=17 Participants
Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study
|
|---|---|
|
Progression-free Survival
|
77 percentage of participants
Interval 60.0 to 99.0
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients receiving AZD2171 (cediranib maleate)
Number of patients who achieve either complete or partial response based on RECIST Criteria for target lesions assessed by MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
n=17 Participants
Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study
|
|---|---|
|
Response Rate
|
0 participants with confirmed response
|
SECONDARY outcome
Timeframe: The time from study entry until death from any cause, assessed up to 1 yearOverall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.
Outcome measures
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
n=17 Participants
Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study
|
|---|---|
|
Overall Survival
|
11.7 months
Interval 7.5 to 13.6
|
POST_HOC outcome
Timeframe: May 2009 through January 2010Participants that discontinued treatment due to a Serious Adverse Event (SAE)
Outcome measures
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
n=17 Participants
Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study
|
|---|---|
|
Discontinued Treatment Due to SAE
|
0 Participants
|
Adverse Events
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
n=17 participants at risk
Patients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study
|
|---|---|
|
Vascular disorders
pulmonary embolism
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
hyperbilirubinemia
|
23.5%
4/17 • Number of events 4
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Nervous system disorders
left subdural hemorrhage
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
AST-SGOT
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Hyponatremia
|
29.4%
5/17 • Number of events 5
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Hepatobiliary disorders
Alk. Phosphatemia
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
ALT-SGPT
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Cardiac disorders
Hypertension
|
29.4%
5/17 • Number of events 5
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Hypophosphatemia
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Respiratory, thoracic and mediastinal disorders
Proteinuria
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Cardiac disorders
Cardiac Ischemia
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
Hematemesis
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
Other adverse events
| Measure |
Singe Arm Open Label Study With AZD2171 at 30 mg Daily
n=17 participants at risk
Patients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.
cediranib maleate: Given orally
laboratory biomarker analysis
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
pharmacological study
|
|---|---|
|
General disorders
Fatigue
|
82.4%
14/17 • Number of events 14
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
AST-SGOT
|
70.6%
12/17 • Number of events 12
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Hyponatremia
|
64.7%
11/17 • Number of events 11
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
10/17 • Number of events 10
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Immune system disorders
Nausea
|
52.9%
9/17 • Number of events 9
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Hepatobiliary disorders
Alk.Phosphatemia
|
47.1%
8/17 • Number of events 8
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
ALT-SGPT
|
47.1%
8/17 • Number of events 8
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Weight loss
|
47.1%
8/17 • Number of events 8
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Anorexia
|
41.2%
7/17 • Number of events 7
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
41.2%
7/17 • Number of events 7
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Cardiac disorders
Hypertension
|
41.2%
7/17 • Number of events 7
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Hypophosphatemia
|
41.2%
7/17 • Number of events 7
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Respiratory, thoracic and mediastinal disorders
Proteinuria
|
41.2%
7/17 • Number of events 7
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.3%
6/17 • Number of events 6
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
6/17 • Number of events 6
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Metabolism and nutrition disorders
Dehydration
|
29.4%
5/17 • Number of events 5
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
29.4%
5/17 • Number of events 5
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Investigations
Leukopenia
|
29.4%
5/17 • Number of events 5
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Investigations
Lymphopenia
|
29.4%
5/17 • Number of events 5
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
4/17 • Number of events 4
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Blood and lymphatic system disorders
Anemia
|
23.5%
4/17 • Number of events 4
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.5%
4/17 • Number of events 4
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
23.5%
4/17 • Number of events 4
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
General disorders
Fever w/o neutropenia
|
17.6%
3/17 • Number of events 3
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
17.6%
3/17 • Number of events 3
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Endocrine disorders
Hypothyroidism
|
17.6%
3/17 • Number of events 3
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Psychiatric disorders
Confusion
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Investigations
Creatinine
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
Stomatitis
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
Taste disturbance
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.8%
2/17 • Number of events 2
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Cardiac disorders
Cardiac ischemia
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Gastrointestinal disorders
Hematemesis
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
|
Social circumstances
Epistaxis
|
5.9%
1/17 • Number of events 1
A total of 77 treatment cycles were administered, with a median of 3 cycles per patient (range: 1-15). Twelve of 17 patients required dose interruptions and subsequent reductions for the following reasons: gr 3 elevated AST (3), gr 3 hyperbilirubinemia (3), gr 3 elevated ALT (2), gr 3 dehydration (1), gr 2 diarrhea (1), and gr 1 proteinuria (2).
|
Additional Information
Andrew X. Zhu, MD
Massachusetts General Hospital Cancer Center
Phone: 617-643-3415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60