Trial Outcomes & Findings for A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer (NCT NCT01427933)
NCT ID: NCT01427933
Last Updated: 2017-02-06
Results Overview
PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Start of treatment until documented disease progression or death from any cause up to 16.5 months
Results posted on
2017-02-06
Participant Flow
Participant Flow reports participants who discontinued from the study. Participants who died due to any cause and participants who were alive at conclusion of the study but off treatment were considered to have completed the study.
Participant milestones
| Measure |
Ramucirumab and Eribulin
Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Eribulin Monotherapy
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
70
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
69
|
65
|
|
Overall Study
COMPLETED
|
63
|
57
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
| Measure |
Ramucirumab and Eribulin
Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Eribulin Monotherapy
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Investigator's Decision
|
1
|
0
|
Baseline Characteristics
A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer
Baseline characteristics by cohort
| Measure |
Ramucirumab and Eribulin
n=71 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Eribulin Monotherapy
n=70 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Gender
Female
|
71 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 participants
n=5 Participants
|
58 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
70 participants
n=7 Participants
|
141 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of treatment until documented disease progression or death from any cause up to 16.5 monthsPopulation: Intent-to-treat Population (ITT): all participants according to their randomized treatment group. Participants censored: Ramucirumab+Eribulin=14; Eribulin=17.
PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.
Outcome measures
| Measure |
Eribulin Monotherapy
n=70 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Ramucirumab and Eribulin
n=71 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
4.1 months
Interval 3.2 to 5.6
|
4.4 months
Interval 3.1 to 6.7
|
SECONDARY outcome
Timeframe: Randomization to date of death from any cause up to 28.6 monthsPopulation: ITT Population: All randomized participants. Participants censored: Ramucirumab and Eribulin=24 , Eribulin Monotherapy=28
Time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date, OS data were censored on the last date the participants were known to be alive prior to that cut-off date.
Outcome measures
| Measure |
Eribulin Monotherapy
n=70 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Ramucirumab and Eribulin
n=71 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Overall Survival (OS) Randomization to Date of Death From Any Cause
|
11.5 Months
Interval 9.0 to 17.3
|
13.5 Months
Interval 10.4 to 17.9
|
SECONDARY outcome
Timeframe: Start of treatment until documented CR or PR up to 16.5 monthsPopulation: ITT population: all participants according to their randomized treatment group.
ORR was defined as the percentage of participants with measurable disease achieving a best overall response of PR or CR as defined by RECIST v.1.1. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in SOD of target lesions. Participants who did not have any post baseline tumor response assessments for any reason were considered non-responders and included in the denominator when calculating the response rate. ORR for each treatment arm calculated as: \[(CR + PR in the treatment arm) divided by (total number of participants in the treatment arm)\] x 100.
Outcome measures
| Measure |
Eribulin Monotherapy
n=70 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Ramucirumab and Eribulin
n=71 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)
|
24.3 percentage of participants
Interval 14.8 to 36.0
|
19.7 percentage of participants
Interval 11.2 to 30.9
|
SECONDARY outcome
Timeframe: Time from Observed CR or PR to PD up to 12.1 monthsPopulation: ITT population: all participants according to their randomized treatment group and who had CR or PR. Participants censored: Ramucirumab+Eribulin=1, Eribulin=3.
DOR was measured from the time criteria were met for first objectively recorded CR or PR until first date criteria for PD was met or death. Response defined using RECIST v1.1 criteria. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of diameter (SOD) of target lesions. PD defined ≥20% increase in SOD of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.
Outcome measures
| Measure |
Eribulin Monotherapy
n=17 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Ramucirumab and Eribulin
n=14 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Duration of Response (DOR) Time of Response to Progressive Disease
|
3.0 months
Interval 1.4 to 4.4
|
5.5 months
Interval 3.1 to 7.1
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: All participants with measurable disease at baseline and at 6 weeks.
CTS was defines as the change from baseline measurement of target lesions to the post treatment measurement in participants with measurable disease. Change was assessed using radiographic imagining. Log ratio calculated as: log of (tumor size post baseline) divided by (tumor size at baseline). A negative result indicated a shrinking tumor.
Outcome measures
| Measure |
Eribulin Monotherapy
n=39 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Ramucirumab and Eribulin
n=43 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Change in Tumor Size (CTS)
|
-0.20 log ratio
Standard Deviation 0.28
|
-0.20 log ratio
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 monthsPopulation: All randomized participants who received at least 1 dose of study drug and assessed for treatment emergent antibodies.
The number of participants who developed treatment-emergent antibody responses after baseline. The antibody test can produce positive results in participants without ramucirumab exposure. Treatment emergent anti-ramucirumab antibody positive was defined as: when baseline titer was greater than 0 and post baseline titer was equal to or greater than 4-fold the baseline titer or if the baseline titer was not detected and post baseline titer is equal to or greater than a value of 20.
Outcome measures
| Measure |
Eribulin Monotherapy
n=41 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Ramucirumab and Eribulin
n=61 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Number of Participants With Anti-Ramucirumab Antibodies
|
2 participants
|
4 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to end of treatment and within 30 days of last dose of study drug (22.6 months)Population: All randomized participants who received at least 1 dose of study drug and according to the treatment received.
Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Eribulin Monotherapy
n=65 Participants
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Ramucirumab and Eribulin
n=69 Participants
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Number of Participants With Adverse Events (AE) and Participants Who Died
SAE
|
12 participants
|
26 participants
|
|
Number of Participants With Adverse Events (AE) and Participants Who Died
Other non-SAE
|
65 participants
|
68 participants
|
|
Number of Participants With Adverse Events (AE) and Participants Who Died
Died
|
32 participants
|
30 participants
|
Adverse Events
Ramucirumab and Eribulin
Serious events: 26 serious events
Other events: 67 other events
Deaths: 0 deaths
Eribulin Monotherapy
Serious events: 12 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab and Eribulin
n=69 participants at risk
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Eribulin Monotherapy
n=65 participants at risk
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
3/69 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Cardiac disorders
Cardiac tamponade
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Ascites
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
1/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Odynophagia
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.9%
2/69 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Stomatitis
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Drug withdrawal syndrome
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Fatigue
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Oedema
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Pain
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Cellulitis
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Peritonitis
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Pleural infection
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Pneumonia
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Septic shock
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Systemic candida
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Investigations
Neutrophil count decreased
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
3/69 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Nervous system disorders
Syncope
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/69
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Vascular disorders
Hypotension
|
1.4%
1/69 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
Other adverse events
| Measure |
Ramucirumab and Eribulin
n=69 participants at risk
Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
Eribulin Monotherapy
n=65 participants at risk
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.8%
13/69 • Number of events 20
SAE's and other non-SAE's are treatment emergent.
|
24.6%
16/65 • Number of events 37
SAE's and other non-SAE's are treatment emergent.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.8%
4/69 • Number of events 15
SAE's and other non-SAE's are treatment emergent.
|
12.3%
8/65 • Number of events 31
SAE's and other non-SAE's are treatment emergent.
|
|
Blood and lymphatic system disorders
Neutropenia
|
39.1%
27/69 • Number of events 71
SAE's and other non-SAE's are treatment emergent.
|
44.6%
29/65 • Number of events 75
SAE's and other non-SAE's are treatment emergent.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.6%
8/69 • Number of events 17
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 13
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.8%
4/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
4.6%
3/65 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
9/69 • Number of events 17
SAE's and other non-SAE's are treatment emergent.
|
13.8%
9/65 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
4/69 • Number of events 5
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Ascites
|
5.8%
4/69 • Number of events 5
SAE's and other non-SAE's are treatment emergent.
|
0.00%
0/65
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Constipation
|
29.0%
20/69 • Number of events 25
SAE's and other non-SAE's are treatment emergent.
|
29.2%
19/65 • Number of events 21
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.6%
17/69 • Number of events 21
SAE's and other non-SAE's are treatment emergent.
|
15.4%
10/65 • Number of events 19
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.2%
5/69 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
9.2%
6/65 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Nausea
|
40.6%
28/69 • Number of events 48
SAE's and other non-SAE's are treatment emergent.
|
41.5%
27/65 • Number of events 41
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Stomatitis
|
11.6%
8/69 • Number of events 11
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
19/69 • Number of events 32
SAE's and other non-SAE's are treatment emergent.
|
26.2%
17/65 • Number of events 24
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Asthenia
|
5.8%
4/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Fatigue
|
62.3%
43/69 • Number of events 77
SAE's and other non-SAE's are treatment emergent.
|
58.5%
38/65 • Number of events 53
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Local swelling
|
4.3%
3/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 5
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Mucosal inflammation
|
8.7%
6/69 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
4.6%
3/65 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Oedema peripheral
|
14.5%
10/69 • Number of events 13
SAE's and other non-SAE's are treatment emergent.
|
16.9%
11/65 • Number of events 12
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Pain
|
7.2%
5/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
General disorders
Pyrexia
|
20.3%
14/69 • Number of events 21
SAE's and other non-SAE's are treatment emergent.
|
7.7%
5/65 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
|
Immune system disorders
Seasonal allergy
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Sinusitis
|
10.1%
7/69 • Number of events 10
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
6/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
13.8%
9/65 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
10.8%
7/65 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
|
Investigations
Alanine aminotransferase increased
|
14.5%
10/69 • Number of events 11
SAE's and other non-SAE's are treatment emergent.
|
7.7%
5/65 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
|
Investigations
Aspartate aminotransferase increased
|
14.5%
10/69 • Number of events 12
SAE's and other non-SAE's are treatment emergent.
|
9.2%
6/65 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
7.7%
5/65 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
|
Investigations
Neutrophil count decreased
|
7.2%
5/69 • Number of events 19
SAE's and other non-SAE's are treatment emergent.
|
12.3%
8/65 • Number of events 27
SAE's and other non-SAE's are treatment emergent.
|
|
Investigations
Weight decreased
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
|
Investigations
White blood cell count decreased
|
8.7%
6/69 • Number of events 17
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.5%
19/69 • Number of events 20
SAE's and other non-SAE's are treatment emergent.
|
18.5%
12/65 • Number of events 13
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.5%
10/69 • Number of events 15
SAE's and other non-SAE's are treatment emergent.
|
10.8%
7/65 • Number of events 8
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.8%
4/69 • Number of events 12
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.7%
6/69 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
10.8%
7/65 • Number of events 8
SAE's and other non-SAE's are treatment emergent.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.8%
4/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
3/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
12.3%
8/65 • Number of events 11
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
9/69 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 12
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.1%
7/69 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.3%
3/69 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.8%
4/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
4.6%
3/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
1/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.7%
6/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
9.2%
6/65 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.6%
8/69 • Number of events 8
SAE's and other non-SAE's are treatment emergent.
|
7.7%
5/65 • Number of events 10
SAE's and other non-SAE's are treatment emergent.
|
|
Nervous system disorders
Dizziness
|
11.6%
8/69 • Number of events 10
SAE's and other non-SAE's are treatment emergent.
|
10.8%
7/65 • Number of events 8
SAE's and other non-SAE's are treatment emergent.
|
|
Nervous system disorders
Dysgeusia
|
8.7%
6/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 5
SAE's and other non-SAE's are treatment emergent.
|
|
Nervous system disorders
Headache
|
39.1%
27/69 • Number of events 39
SAE's and other non-SAE's are treatment emergent.
|
15.4%
10/65 • Number of events 16
SAE's and other non-SAE's are treatment emergent.
|
|
Nervous system disorders
Hypoaesthesia
|
2.9%
2/69 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.9%
2/69 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
7.7%
5/65 • Number of events 8
SAE's and other non-SAE's are treatment emergent.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.7%
15/69 • Number of events 23
SAE's and other non-SAE's are treatment emergent.
|
26.2%
17/65 • Number of events 30
SAE's and other non-SAE's are treatment emergent.
|
|
Psychiatric disorders
Anxiety
|
5.8%
4/69 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
4.6%
3/65 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
|
Psychiatric disorders
Depression
|
4.3%
3/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
9.2%
6/65 • Number of events 7
SAE's and other non-SAE's are treatment emergent.
|
|
Psychiatric disorders
Insomnia
|
13.0%
9/69 • Number of events 9
SAE's and other non-SAE's are treatment emergent.
|
9.2%
6/65 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
|
Renal and urinary disorders
Proteinuria
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
4.6%
3/65 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
12/69 • Number of events 12
SAE's and other non-SAE's are treatment emergent.
|
18.5%
12/65 • Number of events 15
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.3%
14/69 • Number of events 18
SAE's and other non-SAE's are treatment emergent.
|
21.5%
14/65 • Number of events 21
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.2%
5/69 • Number of events 5
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.1%
7/69 • Number of events 8
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 2
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
6/69 • Number of events 6
SAE's and other non-SAE's are treatment emergent.
|
4.6%
3/65 • Number of events 5
SAE's and other non-SAE's are treatment emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
3.1%
2/65 • Number of events 3
SAE's and other non-SAE's are treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
29.0%
20/69 • Number of events 22
SAE's and other non-SAE's are treatment emergent.
|
23.1%
15/65 • Number of events 16
SAE's and other non-SAE's are treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
6.2%
4/65 • Number of events 5
SAE's and other non-SAE's are treatment emergent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.2%
5/69 • Number of events 10
SAE's and other non-SAE's are treatment emergent.
|
4.6%
3/65 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
|
Vascular disorders
Flushing
|
5.8%
4/69 • Number of events 4
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
|
Vascular disorders
Hypertension
|
13.0%
9/69 • Number of events 10
SAE's and other non-SAE's are treatment emergent.
|
1.5%
1/65 • Number of events 1
SAE's and other non-SAE's are treatment emergent.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER