Trial Outcomes & Findings for Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer (NCT NCT00331552)
NCT ID: NCT00331552
Last Updated: 2017-07-26
Results Overview
The dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2017-07-26
Participant Flow
Participant milestones
| Measure |
Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab
Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Period 1: Doxil 30 mg/m^2 (Phase I)
STARTED
|
3
|
0
|
|
Period 1: Doxil 30 mg/m^2 (Phase I)
COMPLETED
|
3
|
0
|
|
Period 1: Doxil 30 mg/m^2 (Phase I)
NOT COMPLETED
|
0
|
0
|
|
Period 2: Doxil 35 mg/m^2 (Phase I)
STARTED
|
0
|
3
|
|
Period 2: Doxil 35 mg/m^2 (Phase I)
COMPLETED
|
0
|
3
|
|
Period 2: Doxil 35 mg/m^2 (Phase I)
NOT COMPLETED
|
0
|
0
|
|
Period 3: Phase II
STARTED
|
24
|
0
|
|
Period 3: Phase II
COMPLETED
|
22
|
0
|
|
Period 3: Phase II
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab
Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Period 3: Phase II
Neurological Symptoms
|
1
|
0
|
|
Period 3: Phase II
Severe Nausea
|
1
|
0
|
Baseline Characteristics
Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=6 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Phase II: Cyclophosphamide, Doxil, Trastuzumab
n=24 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
n=5 Participants
|
57 years
n=7 Participants
|
56.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksThe dose level in which 2 or more patients develop treatment-related toxicity of grade 3 or higher OR require a dose adjustment following the first course of treatment
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=6 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Maximum Tolerated Dose and Optimal Tolerated Dose of Pegylated Liposomal Doxorubicin Hydrochloride (Doxil) When Given in Combination With Cyclophosphamide (Phase I)
|
30 mg/m^2
|
—
|
PRIMARY outcome
Timeframe: 18 monthsCount of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=28 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Efficacy as Assessed by the Overall Clinical Benefit Rate
Complete response
|
0 Participants
|
—
|
|
Efficacy as Assessed by the Overall Clinical Benefit Rate
Partial response
|
6 Participants
|
—
|
|
Efficacy as Assessed by the Overall Clinical Benefit Rate
Stable disease
|
15 Participants
|
—
|
|
Efficacy as Assessed by the Overall Clinical Benefit Rate
Progressive disease
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: Periodically during study treatment, up to 24 weeksCount of participants with grade 1, 2, 3, 4, fatal toxicity, need for dose reduction, treatment interruption, or treatment discontinuation
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=30 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Grade 3 adverse events
|
14 Participants
|
—
|
|
Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Grade 4 adverse events
|
3 Participants
|
—
|
|
Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation
At least one dose held or reduced
|
18 Participants
|
—
|
|
Safety as Assessed by Grade 1, 2, 3, 4, Fatal Toxicity, Need for Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Discontinued due to toxicity
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksCount of phase I participants with treatment related toxicity.
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=3 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
n=3 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Treatment-related Toxicity (Phase I)
Grade 2 Neutropenia
|
0 Participants
|
1 Participants
|
|
Treatment-related Toxicity (Phase I)
Grade 3 Neutropenia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsMedian time to progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or new effusions.
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=22 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Time to Progression (Phase II)
|
6.3 months
Interval 3.6 to
Upper bound of confidence interval is infinite.
|
—
|
SECONDARY outcome
Timeframe: 18 monthsKaplan-Meier estimate assessed at 18 months
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=22 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Progression-free Survival (Phase II)
|
0.16 progression free survival probability
Interval 0.033 to 0.77
|
—
|
SECONDARY outcome
Timeframe: 18 monthsKaplan-Meier estimate assessed at 18 months
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=22 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Overall Survival (Phase II)
|
0.49 survival probability
Interval 0.32 to 0.76
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksCount of participants with a clinical benefit (i.e., complete response, partial response, and stable disease).
Outcome measures
| Measure |
Phase I: Cyclophosphamide, Doxil, Trastuzumab
n=12 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Doxil 35 mg/m^2
n=10 Participants
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Comparison of Clinical Benefit Rate in 2 Subgroups--heavily Pre-treated (1 or More Regimens for Advanced Disease) vs Less Heavily Pre-treated (no Regimens for Advanced Disease) (Phase II)
|
9 Participants
|
7 Participants
|
Adverse Events
Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyclophosphamide, Doxil 30 mg/m^2, Trastuzumab
n=27 participants at risk
Patients receive oral cyclophosphamide once daily on days 1-28 and 30 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
Cyclophosphamide, Doxil 35 mg/m^2, Trastuzumab
n=3 participants at risk
Patients receive oral cyclophosphamide once daily on days 1-28 and 35 mg/m\^2 pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.
pegylated liposomal doxorubicin hydrochloride: Given IV
cyclophosphamide: Given orally
trastuzumab: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
70.4%
19/27
|
100.0%
3/3
|
|
Infections and infestations
Neutropenia
|
66.7%
18/27
|
100.0%
3/3
|
|
Gastrointestinal disorders
Nausea
|
51.9%
14/27
|
33.3%
1/3
|
|
Gastrointestinal disorders
Vomitting
|
11.1%
3/27
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anemia
|
29.6%
8/27
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
7.4%
2/27
|
66.7%
2/3
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
3/27
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
14.8%
4/27
|
0.00%
0/3
|
|
General disorders
Fatigue
|
44.4%
12/27
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastric Reflux
|
7.4%
2/27
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
25.9%
7/27
|
33.3%
1/3
|
|
Gastrointestinal disorders
Mucositis
|
14.8%
4/27
|
33.3%
1/3
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/27
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
7.4%
2/27
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.9%
7/27
|
0.00%
0/3
|
|
General disorders
Weight Loss
|
7.4%
2/27
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
ALT High
|
0.00%
0/27
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
AST High
|
18.5%
5/27
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Erythma
|
11.1%
3/27
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Low Hemoglobin
|
0.00%
0/27
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
3/27
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.4%
2/27
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.8%
4/27
|
33.3%
1/3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.7%
1/27
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
Taste Alteration
|
0.00%
0/27
|
33.3%
1/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.5%
5/27
|
0.00%
0/3
|
Additional Information
Dr. Hannah Linden
University of Washington / Seattle Cancer Care Alliance
Phone: 206-288-6989
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place