Trial Outcomes & Findings for Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab (NCT NCT03093155)
NCT ID: NCT03093155
Last Updated: 2024-05-14
Results Overview
Progression-free survival (PFS), the primary endpoint, will be defined as the length of time from randomization to disease recurrence, disease progression, or death for any reason. The timeframe was updated upon results entry.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Up to 37 months
Results posted on
2024-05-14
Participant Flow
Participant milestones
| Measure |
Ixabepilone
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
40
|
|
Overall Study
Patients Completing Treatment
|
37
|
39
|
|
Overall Study
Patients Requiring Dose Reduction
|
21
|
25
|
|
Overall Study
COMPLETED
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ixabepilone
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Overall Study
Not Eligible
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab
Baseline characteristics by cohort
| Measure |
Ixabepilone
n=37 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=93 Participants
|
67 years
n=4 Participants
|
67 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
27 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=93 Participants
|
39 participants
n=4 Participants
|
76 participants
n=27 Participants
|
|
ECOG Performance Status
0-1
|
31 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
ECOG Performance Status
2
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Histology
Serous
|
29 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Histology
Carcinosarcoma
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Histology
Other
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Prior Lines of Chemotherapy
Less than or Equal to 3
|
18 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Prior Lines of Chemotherapy
Greater than 3
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Prior Bevacizumab
Yes
|
21 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Prior Bevacizumab
No
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 37 monthsPopulation: Those completing treatment post randomization
Progression-free survival (PFS), the primary endpoint, will be defined as the length of time from randomization to disease recurrence, disease progression, or death for any reason. The timeframe was updated upon results entry.
Outcome measures
| Measure |
Ixabepilone
n=37 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab
|
2.20 months
Interval 1.61 to 4.96
|
5.46 months
Interval 3.98 to 11.47
|
SECONDARY outcome
Timeframe: Up to 37 monthsPopulation: Those completing treatment post randomization
Treatment response will be based on RECIST v1.1 Guidelines for measurable lesions. Objective response rate (ORR) includes evaluation for partial response (PR) or complete response (CR). Time frame was updated upon results entry.
Outcome measures
| Measure |
Ixabepilone
n=37 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
3 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 37 monthsPopulation: Those completing treatment post randomization
Overall survival (OS) is defined as time from randomization to death from any cause. Time frame was updated upon results entry.
Outcome measures
| Measure |
Ixabepilone
n=37 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Overall Survival (OS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab
|
6.05 months
Interval 2.83 to 16.8
|
10.32 months
Interval 7.92 to 28.14
|
SECONDARY outcome
Timeframe: Up to 37 monthsPopulation: Those completing treatment post randomization
Safety profile of Ixabepilone in combination with Bevacizumab as defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Presented are the number of participants that experienced SAE's related to study drug. Full reporting of adverse events is presented in the Adverse Events module. Time frame was updated upon results entry.
Outcome measures
| Measure |
Ixabepilone
n=37 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Number of Participants With Treatment Related SAEs
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: Those with prior Taxanes treatment.
Assess whether prior treatment with Taxanes impacts future response to Bevacizumab in combination with Ixabepilone. BEST RESPONSE using RECIST Criteria- Complete Response (CR): The disappearance of all target lesions. There should be no evidence of disease, and any pathological lymph nodes must have reduced in size to normal (short axis less than 10 mm). Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesion
Outcome measures
| Measure |
Ixabepilone
n=13 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=10 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes
Complete Response (CR)
|
0 Participants
|
0 Participants
|
|
Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes
Partial Response (PR)
|
0 Participants
|
3 Participants
|
|
Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes
Stable Disease (SD)
|
7 Participants
|
6 Participants
|
|
Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes
Progressive Disease (PD)
|
5 Participants
|
1 Participants
|
|
Differences in Response to the Combination of Ixabepilone and Bevacizumab in Relationship to Previous Treatment With Bevacizumab and Taxanes
Not Assessed
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 YearsPopulation: Those completing treatment post randomization
Treatment response will be based on RECIST v1.1 Guidelines for measurable lesions. Objective response rate (ORR) includes evaluation for partial response (PR) or complete response (CR). Durable Disease Control (DDC) is defined as complete response (CR), partial response (PR), or stable disease (SD) ≥6 months from date of best response. Presented are the counts of those that achieved DDC.
Outcome measures
| Measure |
Ixabepilone
n=37 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 Participants
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Durable Disease Control Rate (DDCR) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab
|
1 Participants
|
14 Participants
|
Adverse Events
Ixabepilone
Serious events: 24 serious events
Other events: 36 other events
Deaths: 36 deaths
Ixabepilone + Bevacizumab
Serious events: 16 serious events
Other events: 39 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Ixabepilone
n=37 participants at risk
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 participants at risk
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 4 • Up to 37 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
13.5%
5/37 • Number of events 5 • Up to 37 months
|
7.7%
3/39 • Number of events 4 • Up to 37 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
2/37 • Number of events 3 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/37 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Gastrointestinal disorders
Abdominal distension
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Gastrointestinal disorders
Colonic perforation
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 2 • Up to 37 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
General disorders
Pain
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
General disorders
Edema limbs
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Hepatobiliary disorders
Cholecystitis
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Sepsis
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Urinary tract infection
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Infections and infestations
Lung infection
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Investigations
Creatinine increased
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Investigations
Neutrophil count decreased
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Investigations
Platelet count decreased
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Syncope
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Renal and urinary disorders
Acute kidney injury
|
8.1%
3/37 • Number of events 4 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.9%
7/37 • Number of events 7 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Vascular disorders
Hypotension
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
Other adverse events
| Measure |
Ixabepilone
n=37 participants at risk
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
|
Ixabepilone + Bevacizumab
n=39 participants at risk
Ixabepilone 20 mg/m2 days 1, 8, 15
\+ Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Ixabepilone: Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response
Bevacizumab: Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
13.5%
5/37 • Number of events 5 • Up to 37 months
|
25.6%
10/39 • Number of events 21 • Up to 37 months
|
|
Blood and lymphatic system disorders
Anemia
|
16.2%
6/37 • Number of events 8 • Up to 37 months
|
20.5%
8/39 • Number of events 15 • Up to 37 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/37 • Up to 37 months
|
10.3%
4/39 • Number of events 4 • Up to 37 months
|
|
Cardiac disorders
Palpitations
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Ear and labyrinth disorders
Vertigo
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
10.3%
4/39 • Number of events 5 • Up to 37 months
|
|
Endocrine disorders
Hypothyroidism
|
2.7%
1/37 • Number of events 2 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Eye disorders
Blurred vision
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Eye disorders
Eye disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Eye disorders
Cataract
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Eye disorders
Dry eye
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Nausea
|
67.6%
25/37 • Number of events 38 • Up to 37 months
|
76.9%
30/39 • Number of events 41 • Up to 37 months
|
|
Gastrointestinal disorders
Diarrhea
|
59.5%
22/37 • Number of events 36 • Up to 37 months
|
59.0%
23/39 • Number of events 40 • Up to 37 months
|
|
Gastrointestinal disorders
Vomiting
|
54.1%
20/37 • Number of events 28 • Up to 37 months
|
43.6%
17/39 • Number of events 27 • Up to 37 months
|
|
Gastrointestinal disorders
Constipation
|
24.3%
9/37 • Number of events 9 • Up to 37 months
|
43.6%
17/39 • Number of events 19 • Up to 37 months
|
|
Gastrointestinal disorders
Abdominal pain
|
27.0%
10/37 • Number of events 11 • Up to 37 months
|
38.5%
15/39 • Number of events 20 • Up to 37 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
18.9%
7/37 • Number of events 7 • Up to 37 months
|
17.9%
7/39 • Number of events 7 • Up to 37 months
|
|
Gastrointestinal disorders
Abdominal distension
|
24.3%
9/37 • Number of events 10 • Up to 37 months
|
10.3%
4/39 • Number of events 5 • Up to 37 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.8%
4/37 • Number of events 4 • Up to 37 months
|
10.3%
4/39 • Number of events 4 • Up to 37 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/37 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Gastrointestinal disorders
Ascites
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Gastrointestinal disorders
Flatulence
|
2.7%
1/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Rectal pain
|
2.7%
1/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 2 • Up to 37 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Bloating
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Gastrointestinal disorders
Oral pain
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
General disorders
Fatigue
|
64.9%
24/37 • Number of events 53 • Up to 37 months
|
92.3%
36/39 • Number of events 79 • Up to 37 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
32.4%
12/37 • Number of events 14 • Up to 37 months
|
28.2%
11/39 • Number of events 11 • Up to 37 months
|
|
General disorders
Edema limbs
|
21.6%
8/37 • Number of events 9 • Up to 37 months
|
12.8%
5/39 • Number of events 5 • Up to 37 months
|
|
General disorders
Pain
|
10.8%
4/37 • Number of events 4 • Up to 37 months
|
17.9%
7/39 • Number of events 7 • Up to 37 months
|
|
General disorders
Infusion related reaction
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
7.7%
3/39 • Number of events 7 • Up to 37 months
|
|
General disorders
Fever
|
5.4%
2/37 • Number of events 3 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
General disorders
Flu like symptoms
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
General disorders
Non-cardiac chest pain
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
General disorders
Chills
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
General disorders
Gait disturbance
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
General disorders
Infusion site extravasation
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Urinary tract infection
|
24.3%
9/37 • Number of events 15 • Up to 37 months
|
23.1%
9/39 • Number of events 10 • Up to 37 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
12.8%
5/39 • Number of events 5 • Up to 37 months
|
|
Infections and infestations
Lung infection
|
10.8%
4/37 • Number of events 4 • Up to 37 months
|
7.7%
3/39 • Number of events 4 • Up to 37 months
|
|
Infections and infestations
Sinusitis
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Infections and infestations
Skin infection
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/37 • Up to 37 months
|
10.3%
4/39 • Number of events 4 • Up to 37 months
|
|
Infections and infestations
Vaginal infection
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
2/37 • Number of events 4 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Investigations
Weight loss
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
25.6%
10/39 • Number of events 13 • Up to 37 months
|
|
Investigations
Creatinine increased
|
10.8%
4/37 • Number of events 6 • Up to 37 months
|
15.4%
6/39 • Number of events 6 • Up to 37 months
|
|
Investigations
Neutrophil count decreased
|
8.1%
3/37 • Number of events 5 • Up to 37 months
|
15.4%
6/39 • Number of events 12 • Up to 37 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Investigations
White blood cell decreased
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Investigations
Investigations - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Investigations
Lymphocyte count decreased
|
5.4%
2/37 • Number of events 3 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Investigations
Platelet count decreased
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Investigations
Alkaline phosphatase increased
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Metabolism and nutrition disorders
Anorexia
|
45.9%
17/37 • Number of events 17 • Up to 37 months
|
51.3%
20/39 • Number of events 25 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
32.4%
12/37 • Number of events 15 • Up to 37 months
|
23.1%
9/39 • Number of events 15 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.8%
4/37 • Number of events 4 • Up to 37 months
|
15.4%
6/39 • Number of events 7 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
15.4%
6/39 • Number of events 8 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
7.7%
3/39 • Number of events 7 • Up to 37 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
7.7%
3/39 • Number of events 4 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 4 • Up to 37 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.5%
5/37 • Number of events 5 • Up to 37 months
|
25.6%
10/39 • Number of events 13 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
3/37 • Number of events 3 • Up to 37 months
|
23.1%
9/39 • Number of events 9 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
15.4%
6/39 • Number of events 6 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
7.7%
3/39 • Number of events 5 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/37 • Up to 37 months
|
10.3%
4/39 • Number of events 4 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
7.7%
3/39 • Number of events 4 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/37 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
24.3%
9/37 • Number of events 10 • Up to 37 months
|
64.1%
25/39 • Number of events 32 • Up to 37 months
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
28.2%
11/39 • Number of events 13 • Up to 37 months
|
|
Nervous system disorders
Dysgeusia
|
8.1%
3/37 • Number of events 3 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
10.3%
4/39 • Number of events 6 • Up to 37 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Nervous system disorders
Stroke
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Psychiatric disorders
Insomnia
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Psychiatric disorders
Depression
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Renal and urinary disorders
Urinary frequency
|
13.5%
5/37 • Number of events 5 • Up to 37 months
|
15.4%
6/39 • Number of events 6 • Up to 37 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/37 • Up to 37 months
|
20.5%
8/39 • Number of events 16 • Up to 37 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.4%
2/37 • Number of events 3 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Renal and urinary disorders
Urinary urgency
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Renal and urinary disorders
Urinary tract pain
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
1/37 • Number of events 2 • Up to 37 months
|
2.6%
1/39 • Number of events 2 • Up to 37 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.0%
10/37 • Number of events 13 • Up to 37 months
|
33.3%
13/39 • Number of events 14 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37 • Number of events 4 • Up to 37 months
|
28.2%
11/39 • Number of events 11 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
15.4%
6/39 • Number of events 7 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/37 • Up to 37 months
|
12.8%
5/39 • Number of events 5 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/37 • Up to 37 months
|
7.7%
3/39 • Number of events 3 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
13.5%
5/37 • Number of events 5 • Up to 37 months
|
28.2%
11/39 • Number of events 12 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.5%
5/37 • Number of events 6 • Up to 37 months
|
10.3%
4/39 • Number of events 4 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.8%
4/37 • Number of events 4 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/37 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.4%
2/37 • Number of events 2 • Up to 37 months
|
0.00%
0/39 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
|
Vascular disorders
Hypertension
|
10.8%
4/37 • Number of events 4 • Up to 37 months
|
43.6%
17/39 • Number of events 25 • Up to 37 months
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
12.8%
5/39 • Number of events 6 • Up to 37 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.7%
1/37 • Number of events 1 • Up to 37 months
|
5.1%
2/39 • Number of events 2 • Up to 37 months
|
|
Vascular disorders
Phlebitis
|
0.00%
0/37 • Up to 37 months
|
2.6%
1/39 • Number of events 1 • Up to 37 months
|
Additional Information
Alessandro Santin, MD
Yale School of Medicine/Yale Cancer Center
Phone: (203) 737-4450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place