Trial Outcomes & Findings for Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer (NCT NCT00281528)
NCT ID: NCT00281528
Last Updated: 2019-11-22
Results Overview
Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Up to 43 months
Results posted on
2019-11-22
Participant Flow
Participant milestones
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
54
|
79
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
75
|
54
|
79
|
Reasons for withdrawal
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
28
|
18
|
27
|
|
Overall Study
Unacceptable Toxicity-related to trt
|
21
|
24
|
32
|
|
Overall Study
Adverse Event-unrelated to treatment
|
3
|
0
|
2
|
|
Overall Study
Physician Decision
|
11
|
4
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
7
|
|
Overall Study
Other
|
6
|
3
|
5
|
Baseline Characteristics
Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Customized
|
59.0 Years
n=5 Participants
|
56.0 Years
n=7 Participants
|
56.0 Years
n=5 Participants
|
57.0 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic and Non-Latino
|
52 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other (not specified)
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Weight
|
72.9 kilograms
n=5 Participants
|
70.2 kilograms
n=7 Participants
|
73.1 kilograms
n=5 Participants
|
72.2 kilograms
n=4 Participants
|
|
Menopausal status
Pre-menopausal
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Menopausal status
Post-menopausal
|
64 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
43 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
29 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Time from Primary Diagnosis to Study Entry
|
4.320 Years
n=5 Participants
|
3.127 Years
n=7 Participants
|
2.579 Years
n=5 Participants
|
2.983 Years
n=4 Participants
|
|
Participants with Current Diagnosis at Stage IV
|
75 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 43 monthsPopulation: Treated population
Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)
|
41 Percent of Total Participants
|
43 Percent of Total Participants
|
47 Percent of Total Participants
|
PRIMARY outcome
Timeframe: up to 54 monthsPopulation: Treated population who had at least one post baseline value
Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) ANC counts were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal - 75.0\*10\^9L; Grade 2 = \<1.5 - 1.0\*10\^9L; Grade 3 = \<1.0 - 0.5\*10\^9L; Grade 4 = \<0.5\*10\^9L
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=63 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=49 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=70 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 0
|
51 participants
1.569
|
34 participants
3.216
|
17 participants
.750
|
|
Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 1
|
5 participants
|
5 participants
|
17 participants
|
|
Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 3
|
3 participants
|
4 participants
|
17 participants
|
|
Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 4
|
2 participants
|
0 participants
|
2 participants
|
|
Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 2
|
2 participants
|
6 participants
|
17 participants
|
PRIMARY outcome
Timeframe: up to 54 monthsPopulation: Treated population who had at least one post baseline value
Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) WBC counts were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal -3.0\*10\^9/L; Grade 2 = \<3.0 - 2.0\*10\^9/L; Grade 3 = \<2.0 - 1.0\*10\^9/L; Grade 4 = \<1.0\*10\^9/L
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=64 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=49 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=70 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 0
|
47 participants
|
30 participants
|
11 participants
|
|
Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 1
|
9 participants
|
14 participants
|
21 participants
|
|
Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 3
|
2 participants
|
0 participants
|
11 participants
|
|
Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 4
|
0 participants
|
0 participants
|
1 participants
|
|
Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 2
|
6 participants
|
5 participants
|
26 participants
|
PRIMARY outcome
Timeframe: up to 54 monthsPopulation: Treated population who had at least one post baseline value
Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) platelet counts were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal - 75.0\*10\^9/L; Grade 2 = \<75.0 - 50.0\*10\^9/L; Grade 3 = \<50.0 - 25.0\*10\^9/L; Grade 4 = \<25.0\*10\^9/L
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=63 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=49 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=70 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 1
|
2 participants
|
10 participants
|
4 participants
|
|
Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 2
|
1 participants
|
0 participants
|
1 participants
|
|
Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 3
|
0 participants
|
0 participants
|
0 participants
|
|
Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 4
|
0 participants
|
0 participants
|
0 participants
|
|
Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 0
|
60 participants
|
39 participants
|
64 participants
|
PRIMARY outcome
Timeframe: up to 54 monthsPopulation: Treated population who had at least one post baseline value
Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) hemoglobin levels were graded using NCI CTCAE version 3: Grade 0 = within normal limits; Grade 1 = \< lower limit of normal - 100g/L; Grade 2 = \<100 - 80g/L; Grade 3 = \<80 - 65g/L; Grade 4 = \<65g/L
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=64 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=49 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=70 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 1
|
17 participants
|
18 participants
|
33 participants
|
|
Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 0
|
41 participants
|
25 participants
|
13 participants
|
|
Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 2
|
6 participants
|
6 participants
|
19 participants
|
|
Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 3
|
0 participants
|
0 participants
|
4 participants
|
|
Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
Grade 4
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Up to 53 monthsPopulation: Treated population
Participants with at least one dose reduction for ABI-007. ABI-007 (Abraxane) dose could be reduced according to protocol guidelines if the participant was experiencing toxicities. Participants were allowed two ABI-007 (Abraxane) dose reductions during the course of the trial. This outcome is considered to be both a safety and an efficacy outcome.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
The Number of Participants With at Least One Dose Reduction for ABI-007
|
36 Participants
|
32 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: Up to 53 monthsPopulation: Treated population
Participants with at least one dose delay for ABI-007. Treatment delays of no longer than 2 weeks allowed participants to recovery from acute toxicity. If treatment was delayed beyond 2 weeks, continuing treatment on protocol was at the physician's discretion, based upon the best interests of the participant. This outcome is considered to be both a safety and an efficacy outcome.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
The Number of Participants With at Least One Dose Delay for ABI-007
|
40 Participants
|
27 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: Up to 53 monthsPopulation: Treated population
Number of participants who interrupted (omitted) a dose at some point in the treatment period. This outcome is considered to be both a safety and an efficacy outcome.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
The Number of Participants With a Dose Interruption of ABI-007
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 43 months (until progressed)Population: Treated population
Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), the percentage of participants achieving either * A complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or * A partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions or * Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)
|
65 Percent of Total Participants
|
52 Percent of Total Participants
|
58 Percent of Total Participants
|
SECONDARY outcome
Timeframe: Up to 43 months (until progressed)Population: Treated population
Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Kaplan Meier Estimate for Time to Disease Progression (TTP)
|
8.0 Months
Interval 7.0 to 10.3
|
6.3 Months
Interval 5.3 to 8.0
|
9.0 Months
Interval 7.2 to 11.1
|
SECONDARY outcome
Timeframe: Up to 43 months (until progressed)Population: Treated population who achieved a complete or partial response
Duration of response was defined as the time from response to the time of disease progression for participants who achieve an objective confirmed complete (CR) or partial overall response (PR). Disease progression is based on the assessments by the investigator. Participants who did not have disease progression following a confirmed complete or partial target response were censored at the last known time that the participant was evaluated for response
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=33 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=22 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=36 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Kaplan Meier Estimate for Duration of Response
|
10.3 Months
Interval 8.0 to 12.3
|
8.0 Months
Interval 5.5 to 13.4
|
9.9 Months
Interval 7.7 to 15.7
|
SECONDARY outcome
Timeframe: Up to 56 monthsPopulation: Treated population
Participant survival was summarized using Kaplan-Meier estimate of the time of first dose of study drug to the last known time that the participant was alive. Participants that were alive at the end of follow-up would be censored at the last known time that the patient was alive.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Kaplan Meier Estimate for Participant Survival
|
21.3 Months
Interval 19.5 to 26.6
|
19.0 Months
Interval 15.0 to 28.1
|
23.7 Months
Interval 18.2 to 31.0
|
SECONDARY outcome
Timeframe: up to 56 monthsPopulation: Treated population
PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Outcome measures
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 Participants
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 Participants
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 Participants
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Kaplan Meier Estimate for Progression-Free Survival (PFS)
|
7.7 months
Interval 7.3 to 8.8
|
6.3 months
Interval 5.3 to 8.0
|
8.8 months
Interval 5.8 to 9.9
|
Adverse Events
260 mg/m^2 ABI-007 Every 3 Weeks
Serious events: 22 serious events
Other events: 75 other events
Deaths: 0 deaths
260 mg/m^2 ABI-007 Every 2 Weeks
Serious events: 16 serious events
Other events: 54 other events
Deaths: 0 deaths
130 mg/m^2 ABI-007 Weekly
Serious events: 32 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 participants at risk
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 participants at risk
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 participants at risk
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Cardiac disorders
Cardiac failure congestive
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
3.8%
3/79 • Number of events 3 • Up to 54 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
General disorders
Asthenia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 2 • Up to 54 months
|
|
General disorders
Catheter site pain
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
General disorders
Chest pain
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
General disorders
Fatigue
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
General disorders
Gait disturbance
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
General disorders
Mucosal inflammation
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
General disorders
Pyrexia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
Hepatobiliary disorders
Hepatic failure
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Infections and infestations
Appendicitis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Infections and infestations
Breast cellulitis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Infections and infestations
Infection
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
6.3%
5/79 • Number of events 5 • Up to 54 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Nervous system disorders
Cranial neuropathy
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Nervous system disorders
Headache
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/75 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
Nervous system disorders
Neuropathy peripheral
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Psychiatric disorders
Major depression
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Renal and urinary disorders
Hydronephrosis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Vascular disorders
Haematoma
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Vascular disorders
Thrombosis
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 2 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/75 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
Other adverse events
| Measure |
260 mg/m^2 ABI-007 Every 3 Weeks
n=75 participants at risk
260 mg/m\^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
|
260 mg/m^2 ABI-007 Every 2 Weeks
n=54 participants at risk
260 mg/m\^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
|
130 mg/m^2 ABI-007 Weekly
n=79 participants at risk
130 mg/m\^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
15/75 • Number of events 24 • Up to 54 months
|
37.0%
20/54 • Number of events 32 • Up to 54 months
|
30.4%
24/79 • Number of events 37 • Up to 54 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.0%
6/75 • Number of events 32 • Up to 54 months
|
7.4%
4/54 • Number of events 7 • Up to 54 months
|
13.9%
11/79 • Number of events 23 • Up to 54 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.0%
18/75 • Number of events 52 • Up to 54 months
|
16.7%
9/54 • Number of events 13 • Up to 54 months
|
39.2%
31/79 • Number of events 63 • Up to 54 months
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
6.3%
5/79 • Number of events 5 • Up to 54 months
|
|
Eye disorders
Dry eye
|
6.7%
5/75 • Number of events 5 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
5.1%
4/79 • Number of events 6 • Up to 54 months
|
|
Eye disorders
Lacrimation increased
|
4.0%
3/75 • Number of events 3 • Up to 54 months
|
9.3%
5/54 • Number of events 5 • Up to 54 months
|
17.7%
14/79 • Number of events 22 • Up to 54 months
|
|
Eye disorders
Vision blurred
|
12.0%
9/75 • Number of events 10 • Up to 54 months
|
16.7%
9/54 • Number of events 10 • Up to 54 months
|
13.9%
11/79 • Number of events 13 • Up to 54 months
|
|
Eye disorders
Visual disturbance
|
5.3%
4/75 • Number of events 5 • Up to 54 months
|
1.9%
1/54 • Number of events 2 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
3/75 • Number of events 3 • Up to 54 months
|
5.6%
3/54 • Number of events 5 • Up to 54 months
|
6.3%
5/79 • Number of events 5 • Up to 54 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
9/75 • Number of events 16 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
13.9%
11/79 • Number of events 12 • Up to 54 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
4/75 • Number of events 6 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
11.4%
9/79 • Number of events 10 • Up to 54 months
|
|
Gastrointestinal disorders
Constipation
|
40.0%
30/75 • Number of events 41 • Up to 54 months
|
51.9%
28/54 • Number of events 29 • Up to 54 months
|
48.1%
38/79 • Number of events 54 • Up to 54 months
|
|
Gastrointestinal disorders
Diarrhoea
|
32.0%
24/75 • Number of events 42 • Up to 54 months
|
44.4%
24/54 • Number of events 36 • Up to 54 months
|
54.4%
43/79 • Number of events 62 • Up to 54 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
4/75 • Number of events 4 • Up to 54 months
|
5.6%
3/54 • Number of events 4 • Up to 54 months
|
6.3%
5/79 • Number of events 6 • Up to 54 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.7%
11/75 • Number of events 13 • Up to 54 months
|
3.7%
2/54 • Number of events 3 • Up to 54 months
|
7.6%
6/79 • Number of events 6 • Up to 54 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
4/75 • Number of events 4 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
3.8%
3/79 • Number of events 3 • Up to 54 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
10.1%
8/79 • Number of events 8 • Up to 54 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
1.9%
1/54 • Number of events 2 • Up to 54 months
|
6.3%
5/79 • Number of events 5 • Up to 54 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.0%
3/75 • Number of events 3 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
7.6%
6/79 • Number of events 6 • Up to 54 months
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
2.5%
2/79 • Number of events 3 • Up to 54 months
|
|
Gastrointestinal disorders
Nausea
|
49.3%
37/75 • Number of events 53 • Up to 54 months
|
66.7%
36/54 • Number of events 53 • Up to 54 months
|
50.6%
40/79 • Number of events 58 • Up to 54 months
|
|
Gastrointestinal disorders
Oral pain
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
5.1%
4/79 • Number of events 5 • Up to 54 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/75 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
7.6%
6/79 • Number of events 7 • Up to 54 months
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
10/75 • Number of events 14 • Up to 54 months
|
14.8%
8/54 • Number of events 9 • Up to 54 months
|
16.5%
13/79 • Number of events 18 • Up to 54 months
|
|
Gastrointestinal disorders
Vomiting
|
21.3%
16/75 • Number of events 20 • Up to 54 months
|
33.3%
18/54 • Number of events 25 • Up to 54 months
|
26.6%
21/79 • Number of events 28 • Up to 54 months
|
|
General disorders
Asthenia
|
5.3%
4/75 • Number of events 5 • Up to 54 months
|
20.4%
11/54 • Number of events 13 • Up to 54 months
|
10.1%
8/79 • Number of events 10 • Up to 54 months
|
|
General disorders
Chest pain
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
7.4%
4/54 • Number of events 5 • Up to 54 months
|
8.9%
7/79 • Number of events 9 • Up to 54 months
|
|
General disorders
Chills
|
8.0%
6/75 • Number of events 8 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
13.9%
11/79 • Number of events 13 • Up to 54 months
|
|
General disorders
Fatigue
|
73.3%
55/75 • Number of events 127 • Up to 54 months
|
79.6%
43/54 • Number of events 82 • Up to 54 months
|
81.0%
64/79 • Number of events 137 • Up to 54 months
|
|
General disorders
Gait disturbance
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
General disorders
Mucosal inflammation
|
18.7%
14/75 • Number of events 17 • Up to 54 months
|
24.1%
13/54 • Number of events 15 • Up to 54 months
|
20.3%
16/79 • Number of events 28 • Up to 54 months
|
|
Gastrointestinal disorders
Oedema
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
6.3%
5/79 • Number of events 6 • Up to 54 months
|
|
General disorders
Oedema peripheral
|
8.0%
6/75 • Number of events 10 • Up to 54 months
|
18.5%
10/54 • Number of events 11 • Up to 54 months
|
13.9%
11/79 • Number of events 15 • Up to 54 months
|
|
General disorders
Pain
|
8.0%
6/75 • Number of events 6 • Up to 54 months
|
20.4%
11/54 • Number of events 13 • Up to 54 months
|
13.9%
11/79 • Number of events 15 • Up to 54 months
|
|
General disorders
Pyrexia
|
12.0%
9/75 • Number of events 10 • Up to 54 months
|
20.4%
11/54 • Number of events 12 • Up to 54 months
|
13.9%
11/79 • Number of events 19 • Up to 54 months
|
|
Immune system disorders
Hypersensitivity
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Infections and infestations
Cellulitis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
5.1%
4/79 • Number of events 8 • Up to 54 months
|
|
Infections and infestations
Nail infection
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
5.1%
4/79 • Number of events 5 • Up to 54 months
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
6.3%
5/79 • Number of events 7 • Up to 54 months
|
|
Infections and infestations
Oral candidiasis
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
Infections and infestations
Sinusitis
|
5.3%
4/75 • Number of events 4 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
8.9%
7/79 • Number of events 9 • Up to 54 months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.0%
9/75 • Number of events 10 • Up to 54 months
|
9.3%
5/54 • Number of events 5 • Up to 54 months
|
11.4%
9/79 • Number of events 9 • Up to 54 months
|
|
Infections and infestations
Urinary tract infection
|
17.3%
13/75 • Number of events 21 • Up to 54 months
|
16.7%
9/54 • Number of events 10 • Up to 54 months
|
15.2%
12/79 • Number of events 13 • Up to 54 months
|
|
Investigations
Haemoglobin decreased
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
3.8%
3/79 • Number of events 4 • Up to 54 months
|
|
Investigations
Weight decreased
|
5.3%
4/75 • Number of events 7 • Up to 54 months
|
16.7%
9/54 • Number of events 11 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
Metabolism and nutrition disorders
Anorexia
|
21.3%
16/75 • Number of events 20 • Up to 54 months
|
35.2%
19/54 • Number of events 26 • Up to 54 months
|
30.4%
24/79 • Number of events 33 • Up to 54 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
4/75 • Number of events 4 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
7.6%
6/79 • Number of events 6 • Up to 54 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
3/75 • Number of events 3 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
8.9%
7/79 • Number of events 8 • Up to 54 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
11.1%
6/54 • Number of events 6 • Up to 54 months
|
8.9%
7/79 • Number of events 8 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
34.7%
26/75 • Number of events 60 • Up to 54 months
|
38.9%
21/54 • Number of events 24 • Up to 54 months
|
20.3%
16/79 • Number of events 20 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
12/75 • Number of events 12 • Up to 54 months
|
16.7%
9/54 • Number of events 10 • Up to 54 months
|
13.9%
11/79 • Number of events 20 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
18.7%
14/75 • Number of events 16 • Up to 54 months
|
33.3%
18/54 • Number of events 22 • Up to 54 months
|
7.6%
6/79 • Number of events 9 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.7%
2/75 • Number of events 4 • Up to 54 months
|
9.3%
5/54 • Number of events 5 • Up to 54 months
|
8.9%
7/79 • Number of events 7 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.7%
2/75 • Number of events 3 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.7%
11/75 • Number of events 14 • Up to 54 months
|
18.5%
10/54 • Number of events 14 • Up to 54 months
|
12.7%
10/79 • Number of events 10 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.7%
14/75 • Number of events 20 • Up to 54 months
|
20.4%
11/54 • Number of events 16 • Up to 54 months
|
17.7%
14/79 • Number of events 19 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
0.00%
0/79 • Up to 54 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.7%
5/75 • Number of events 5 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
7.6%
6/79 • Number of events 8 • Up to 54 months
|
|
Nervous system disorders
Coordination abnormal
|
6.7%
5/75 • Number of events 5 • Up to 54 months
|
1.9%
1/54 • Number of events 4 • Up to 54 months
|
3.8%
3/79 • Number of events 3 • Up to 54 months
|
|
Nervous system disorders
Dizziness
|
20.0%
15/75 • Number of events 17 • Up to 54 months
|
18.5%
10/54 • Number of events 10 • Up to 54 months
|
13.9%
11/79 • Number of events 13 • Up to 54 months
|
|
Nervous system disorders
Dysgeusia
|
18.7%
14/75 • Number of events 16 • Up to 54 months
|
25.9%
14/54 • Number of events 17 • Up to 54 months
|
35.4%
28/79 • Number of events 36 • Up to 54 months
|
|
Nervous system disorders
Headache
|
20.0%
15/75 • Number of events 17 • Up to 54 months
|
20.4%
11/54 • Number of events 14 • Up to 54 months
|
22.8%
18/79 • Number of events 28 • Up to 54 months
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
1/75 • Number of events 3 • Up to 54 months
|
5.6%
3/54 • Number of events 5 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
Nervous system disorders
Neuropathy
|
45.3%
34/75 • Number of events 96 • Up to 54 months
|
44.4%
24/54 • Number of events 77 • Up to 54 months
|
43.0%
34/79 • Number of events 94 • Up to 54 months
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
15/75 • Number of events 36 • Up to 54 months
|
16.7%
9/54 • Number of events 12 • Up to 54 months
|
16.5%
13/79 • Number of events 41 • Up to 54 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.3%
1/75 • Number of events 2 • Up to 54 months
|
5.6%
3/54 • Number of events 4 • Up to 54 months
|
5.1%
4/79 • Number of events 6 • Up to 54 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
45.3%
34/75 • Number of events 104 • Up to 54 months
|
44.4%
24/54 • Number of events 63 • Up to 54 months
|
45.6%
36/79 • Number of events 111 • Up to 54 months
|
|
Psychiatric disorders
Anxiety
|
5.3%
4/75 • Number of events 4 • Up to 54 months
|
13.0%
7/54 • Number of events 7 • Up to 54 months
|
10.1%
8/79 • Number of events 8 • Up to 54 months
|
|
Psychiatric disorders
Depression
|
16.0%
12/75 • Number of events 12 • Up to 54 months
|
14.8%
8/54 • Number of events 9 • Up to 54 months
|
13.9%
11/79 • Number of events 13 • Up to 54 months
|
|
Psychiatric disorders
Insomnia
|
22.7%
17/75 • Number of events 19 • Up to 54 months
|
31.5%
17/54 • Number of events 18 • Up to 54 months
|
12.7%
10/79 • Number of events 11 • Up to 54 months
|
|
Renal and urinary disorders
Dysuria
|
6.7%
5/75 • Number of events 5 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
2.5%
2/79 • Number of events 4 • Up to 54 months
|
|
Renal and urinary disorders
Pollakiuria
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
5.1%
4/79 • Number of events 5 • Up to 54 months
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
5/75 • Number of events 5 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
3.8%
3/79 • Number of events 4 • Up to 54 months
|
|
Renal and urinary disorders
Urinary incontinence
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
20/75 • Number of events 24 • Up to 54 months
|
14.8%
8/54 • Number of events 9 • Up to 54 months
|
25.3%
20/79 • Number of events 26 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
13.3%
10/75 • Number of events 10 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
16.5%
13/79 • Number of events 13 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.3%
13/75 • Number of events 13 • Up to 54 months
|
16.7%
9/54 • Number of events 11 • Up to 54 months
|
26.6%
21/79 • Number of events 27 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
42.7%
32/75 • Number of events 44 • Up to 54 months
|
42.6%
23/54 • Number of events 25 • Up to 54 months
|
53.2%
42/79 • Number of events 53 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
3/75 • Number of events 3 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.0%
3/75 • Number of events 4 • Up to 54 months
|
14.8%
8/54 • Number of events 10 • Up to 54 months
|
10.1%
8/79 • Number of events 9 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
4/75 • Number of events 6 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
5.1%
4/79 • Number of events 5 • Up to 54 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.0%
3/75 • Number of events 3 • Up to 54 months
|
7.4%
4/54 • Number of events 4 • Up to 54 months
|
11.4%
9/79 • Number of events 11 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
65.3%
49/75 • Number of events 51 • Up to 54 months
|
64.8%
35/54 • Number of events 45 • Up to 54 months
|
67.1%
53/79 • Number of events 68 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.3%
7/75 • Number of events 7 • Up to 54 months
|
14.8%
8/54 • Number of events 8 • Up to 54 months
|
15.2%
12/79 • Number of events 12 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
2/75 • Number of events 2 • Up to 54 months
|
9.3%
5/54 • Number of events 6 • Up to 54 months
|
6.3%
5/79 • Number of events 6 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
5.3%
4/75 • Number of events 4 • Up to 54 months
|
9.3%
5/54 • Number of events 6 • Up to 54 months
|
12.7%
10/79 • Number of events 11 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
12.0%
9/75 • Number of events 9 • Up to 54 months
|
14.8%
8/54 • Number of events 11 • Up to 54 months
|
29.1%
23/79 • Number of events 42 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/75 • Up to 54 months
|
7.4%
4/54 • Number of events 5 • Up to 54 months
|
2.5%
2/79 • Number of events 2 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Onychorrhexis
|
0.00%
0/75 • Up to 54 months
|
5.6%
3/54 • Number of events 4 • Up to 54 months
|
1.3%
1/79 • Number of events 3 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
5/75 • Number of events 6 • Up to 54 months
|
5.6%
3/54 • Number of events 4 • Up to 54 months
|
8.9%
7/79 • Number of events 7 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.7%
20/75 • Number of events 23 • Up to 54 months
|
31.5%
17/54 • Number of events 25 • Up to 54 months
|
39.2%
31/79 • Number of events 42 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/75 • Up to 54 months
|
3.7%
2/54 • Number of events 2 • Up to 54 months
|
8.9%
7/79 • Number of events 8 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.3%
1/75 • Number of events 2 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
5.6%
3/54 • Number of events 3 • Up to 54 months
|
8.9%
7/79 • Number of events 9 • Up to 54 months
|
|
Vascular disorders
Hot flush
|
6.7%
5/75 • Number of events 7 • Up to 54 months
|
7.4%
4/54 • Number of events 5 • Up to 54 months
|
8.9%
7/79 • Number of events 7 • Up to 54 months
|
|
Vascular disorders
Hypertension
|
25.3%
19/75 • Number of events 27 • Up to 54 months
|
16.7%
9/54 • Number of events 9 • Up to 54 months
|
13.9%
11/79 • Number of events 17 • Up to 54 months
|
|
Vascular disorders
Lymphoedema
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
1.9%
1/54 • Number of events 1 • Up to 54 months
|
10.1%
8/79 • Number of events 12 • Up to 54 months
|
|
Infections and infestations
Ear infection
|
1.3%
1/75 • Number of events 1 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
5.1%
4/79 • Number of events 4 • Up to 54 months
|
|
Investigations
Blood pressure increased
|
5.3%
4/75 • Number of events 4 • Up to 54 months
|
0.00%
0/54 • Up to 54 months
|
1.3%
1/79 • Number of events 1 • Up to 54 months
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation
- Publication restrictions are in place
Restriction type: OTHER