Trial Outcomes & Findings for Amgen 386 for Recurrent Glioblastoma (NCT NCT01290263)
NCT ID: NCT01290263
Last Updated: 2017-07-02
Results Overview
PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: \>= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: \> 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: d
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
6 months
Results posted on
2017-07-02
Participant Flow
As of August 1, 2013, Cohort A was closed to new accrual following early interim analysis of first 10 participants enrolled on study showed insufficient efficacy per design.
Participant milestones
| Measure |
Cohort A: AMG 386 30 mg/kg
Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab
Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab
Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg.
|
Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab
Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
All Cohort B Participants: AMG 386 + Bevacizumab
Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
3
|
7
|
27
|
37
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
7
|
27
|
37
|
Reasons for withdrawal
| Measure |
Cohort A: AMG 386 30 mg/kg
Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab
Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab
Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg.
|
Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab
Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
All Cohort B Participants: AMG 386 + Bevacizumab
Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
8
|
2
|
7
|
24
|
33
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
1
|
2
|
|
Overall Study
Participant Non-Compliance
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Amgen 386 for Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Cohort B: AMG 386 + Bevacizumab
n=37 Participants
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=11 Participants
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=39 Participants
|
62 years
n=41 Participants
|
62 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Number of Prior Relapses
1
|
23 participants
n=39 Participants
|
8 participants
n=41 Participants
|
31 participants
n=35 Participants
|
|
Number of Prior Relapses
2
|
14 participants
n=39 Participants
|
2 participants
n=41 Participants
|
16 participants
n=35 Participants
|
|
Number of Prior Relapses
3
|
0 participants
n=39 Participants
|
1 participants
n=41 Participants
|
1 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: \>= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: \> 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: d
Outcome measures
| Measure |
All Cohort B Participants: AMG 386 + Bevacizumab
n=37 Participants
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=11 Participants
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
6-Month Progression-Free Survival (PFS6) [Cohort A and Cohort B]
|
0.243 proportion of participants
Interval 0.12 to 0.38
|
0 proportion of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Participants were assessed weekly while on study; the observation period for MTD evaluation was the first 28 days of study treatment.Population: All phase I Cohort B participants who received at least one dose of the study drug were evaluable for MTD. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.
The MTD of weekly AMG 386 intravenously (IV) in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).
Outcome measures
| Measure |
All Cohort B Participants: AMG 386 + Bevacizumab
n=3 Participants
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=7 Participants
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
AMG 386 Maximum Tolerated Dose (MTD) [Cohort B Phase I]
|
30 mg/kg intravenously on days 1 and 15
|
30 mg/kg intravenously on days 1 and 15
|
PRIMARY outcome
Timeframe: Participants were assessed weekly while on study; the observation period for DLT evaluation was the first 28 days of study treatment.Population: All phase I Cohort B participants who completed 28 days on study treatment were evaluable. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.
A DLT is defined as an adverse event that (a) is related to the AMG 386 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 28 days of the study treatment, and (c) meets any of the following criteria: \>= grade 3 thrombocytopenia; grade 4 neutropenia lasting \> 7 days; grade 4 anemia lasting \> 7 days despite transfusion or growth factors; febrile neutropenia if ANC\<0.5x10\^9/L; clinically significant grade 3 non-hematologic toxicity despite maximal medical therapy lasting \> 7 days, with the exception of grade 3 proteinuria which was considered a DLT if lasting \> 14 days; grade 3 non-hematologic toxicity resulting in study drug discontinuation; grade 4 non-hematologic toxicity; \>= grade 1 new CNS hemorrhage; \>= grade 2 non-CNS hemorrhage.
Outcome measures
| Measure |
All Cohort B Participants: AMG 386 + Bevacizumab
n=3 Participants
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=7 Participants
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
AMG 386 Dose Limiting Toxicity (DLT) [Cohort B Phase I]
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Disease was assessed radiographically for response every 8 weeks.Population: All participants who received at least one dose of the study drug were evaluable for response.
Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: \>= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: \> 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR, PR or PD, stable non-enhancing lesions, and stable clinically.
Outcome measures
| Measure |
All Cohort B Participants: AMG 386 + Bevacizumab
n=37 Participants
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=11 Participants
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Best Radiographic Response [Cohort A and Cohort B]
Complete Response
|
0 participants
|
0 participants
|
|
Best Radiographic Response [Cohort A and Cohort B]
Partial Response
|
4 participants
|
0 participants
|
|
Best Radiographic Response [Cohort A and Cohort B]
Stable Disease
|
20 participants
|
1 participants
|
|
Best Radiographic Response [Cohort A and Cohort B]
Progressive Disease
|
10 participants
|
8 participants
|
|
Best Radiographic Response [Cohort A and Cohort B]
Unknown
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Participants were followed long-term for survival every 3 to 4 months from the end of treatment until death or lost to follow-up. On Cohort A and B participants were followed up to 554 days and 442 days.Population: All participants who received at least one dose of the study drug were followed for OS.
OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.
Outcome measures
| Measure |
All Cohort B Participants: AMG 386 + Bevacizumab
n=37 Participants
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=11 Participants
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) [Cohort A and Cohort B]
|
285 days
Interval 225.0 to 442.0
|
341 days
Interval 138.0 to 554.0
|
SECONDARY outcome
Timeframe: Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks. On Cohort A and B participants were followed for progression up to 36 days and 166 days.Population: All participants who received at least one dose of the study drug were evaluable for PFS.
PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression or death. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).
Outcome measures
| Measure |
All Cohort B Participants: AMG 386 + Bevacizumab
n=37 Participants
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=11 Participants
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-Free Survival (PFS) [Cohort A and Cohort B]
|
108 days
Interval 56.0 to 166.0
|
21 days
Interval 5.0 to 36.0
|
Adverse Events
Cohort B: AMG 386 + Bevacizumab
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Cohort A: AMG 386 30 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort B: AMG 386 + Bevacizumab
n=37 participants at risk
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=11 participants at risk
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Platelet count decreased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Edema Limbs
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Neutrophil Count Decreased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
Other adverse events
| Measure |
Cohort B: AMG 386 + Bevacizumab
n=37 participants at risk
All Phase I \& II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
|
Cohort A: AMG 386 30 mg/kg
n=11 participants at risk
All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Cardiac disorders
Atrial Flutter
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Cardiac disorders
Pericardial Effusion
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Eye disorders
Blurred Vision
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/37 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/37 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Nausea
|
8.1%
3/37 • Number of events 3 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
18.2%
2/11 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Stomach Pain
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Edema Face
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Edema Limbs
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Fatigue
|
8.1%
3/37 • Number of events 3 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
18.2%
2/11 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Infusion Related Reaction
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Infusion Site Reaction
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Localized Edema
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
General disorders
Gait Disturbance
|
0.00%
0/37 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Alkaline Phosphatase Increased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Blood Bilirubin Increased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Cardiac Troponin I Increased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Neutrophil Count Decreased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
Platelet Count Decreased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Investigations
White Blood Cell Decreased
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/37 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Nervous system disorders
Presyncope
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/37 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Renal and urinary disorders
Hematuria
|
8.1%
3/37 • Number of events 3 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Renal and urinary disorders
Proteinuria
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.1%
3/37 • Number of events 3 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.2%
6/37 • Number of events 6 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
2/37 • Number of events 2 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Vascular disorders
Hypertension
|
8.1%
3/37 • Number of events 3 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Vascular disorders
Thromboembolic Event
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Eye disorders
Other - Conjunctival Hemorrhage
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Gastrointestinal disorders
Other - Indigestion/heartburn
|
0.00%
0/37 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
9.1%
1/11 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
|
Skin and subcutaneous tissue disorders
Other - Livedo Reticularis
|
2.7%
1/37 • Number of events 1 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
0.00%
0/11 • Assessed each treatment cycle (1 cycle = 28 days) from time of first dose and up to day 30 post-treatment. Treatment duration in cycles was a median (range) of 1 (1-2) Cohort A and 4 (1-20) Cohort B.
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and causing a hospitalization, deemed serious by the treating investigator or grade 5 events per CTCAE v4. Other AEs were defined as events with AMG386 and/or bevacizumab treatment-attribution of at least possibly and not requiring a hospitalization or deemed non-serious by treating investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place