Trial Outcomes & Findings for A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer (NCT NCT00913835)
NCT ID: NCT00913835
Last Updated: 2019-09-26
Results Overview
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)
Results posted on
2019-09-26
Participant Flow
Participants from liposomal doxorubicin (Lip Dox) treatment group who had progressive disease (PD) had the option to receive to Olaratumab (Olara) monotherapy. Participants who had evidence of PD, died in either period, or received optional Olaratumab monotherapy from liposomal doxorubicin monotherapy were considered to have completed the study.
Participant milestones
| Measure |
Olaratumab + Liposomal Doxorubicin
20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.
40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
|---|---|---|
|
Olara+Lip Dox and Lip Dox Monotherapy
STARTED
|
63
|
62
|
|
Olara+Lip Dox and Lip Dox Monotherapy
Received Any Study Drug
|
62
|
61
|
|
Olara+Lip Dox and Lip Dox Monotherapy
COMPLETED
|
55
|
55
|
|
Olara+Lip Dox and Lip Dox Monotherapy
NOT COMPLETED
|
8
|
7
|
|
Lip Dox: Olaratumab Monotherapy
STARTED
|
0
|
28
|
|
Lip Dox: Olaratumab Monotherapy
Received at Least 1 Dose of Study Drug
|
0
|
28
|
|
Lip Dox: Olaratumab Monotherapy
COMPLETED
|
0
|
25
|
|
Lip Dox: Olaratumab Monotherapy
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Olaratumab + Liposomal Doxorubicin
20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.
40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
|---|---|---|
|
Olara+Lip Dox and Lip Dox Monotherapy
Withdrawal by Subject
|
2
|
3
|
|
Olara+Lip Dox and Lip Dox Monotherapy
Lost to Follow-up
|
1
|
0
|
|
Olara+Lip Dox and Lip Dox Monotherapy
Other
|
4
|
3
|
|
Olara+Lip Dox and Lip Dox Monotherapy
Off Study Treatment/Alive
|
1
|
1
|
|
Lip Dox: Olaratumab Monotherapy
Other
|
0
|
3
|
Baseline Characteristics
A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Olaratumab and Liposomal Doxorubicin
n=62 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=61 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.70 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 9.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian of Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0-Fully Active
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1-ambulatory, able to do light/sedentary nature
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Stratification Factor
Platinum Refractory
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Stratification Factor
Platinum Resistant
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)Population: Modified Intent to Treat (mITT) Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=13, Liposomal Doxorubicin=14.
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=62 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=61 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
18.1 weeks
Interval 8.7 to 27.0
|
17.3 weeks
Interval 14.1 to 31.9
|
—
|
SECONDARY outcome
Timeframe: First Day of Therapy to Date of Death (Up to 35 Months)Population: mITT Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=21, Liposomal Doxorubicin=23.
OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=62 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=61 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Overall Survival (OS)
|
72.3 weeks
Interval 52.4 to 86.7
|
70.6 weeks
Interval 51.4 to 106.4
|
—
|
SECONDARY outcome
Timeframe: Randomization to PD (Up to 35 Months)Population: mITT Population: All randomized participants who received any amount of study drug.
The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) \* 100.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=62 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=61 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
|
12.9 percentage of participants
Interval 6.6 to 22.1
|
16.4 percentage of participants
Interval 9.2 to 26.2
|
—
|
SECONDARY outcome
Timeframe: Date of Initial CR or PR to PD (Up to 35 Months)Population: All participants who achieved CR or PR. Participants censored: Olaratumab=2, Liposomal Doxorubicin=4.
Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=8 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=10 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Median Duration of Response
|
39.1 weeks
Interval 26.1 to 56.1
|
16.9 weeks
Interval 15.3 to
Upper limit of confidence interval (CI) not estimable, did not reach the upper limit of CI.
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)Population: All randomized participants who received any amount of study drug.
Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=62 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=61 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=28 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Who Died
Deaths on treatment or within 30 days of last dose
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) and Who Died
SAEs
|
27 participants
|
23 participants
|
14 participants
|
|
Number of Participants With Adverse Events (AEs) and Who Died
Other Non-SAEs
|
62 participants
|
60 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Baseline Up to 30-Day Postdose Follow-Up (Up To 35 Months)Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.
Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=57 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=20 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Anti-Olaratumab Antibodies
|
1.8 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)Population: Participants who received Olaratumab treatment after PD on liposomal doxorubicin monotherapy. Participants censored=4
PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=28 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)
|
7.7 weeks
Interval 7.1 to 10.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)Population: Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)Population: Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)Population: Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.
The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)Population: Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.
CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)Population: Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to PD or Date of Death (Up to 130 Weeks)Population: All participants who had evaluable PDGFRα results.
PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is \>0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.
Outcome measures
| Measure |
Olaratumab and Liposomal Doxorubicin
n=54 Participants
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=47 Participants
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)
High Expression (n=41, 36)
|
21.0 weeks
Interval 8.7 to 34.1
|
17.3 weeks
Interval 12.3 to 33.9
|
—
|
|
PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)
Low Expression (n=13,11)
|
32.7 weeks
Interval 7.6 to 41.3
|
24.0 weeks
Interval 8.1 to 36.1
|
—
|
Adverse Events
Olaratumab and Liposomal Doxorubicin
Serious events: 27 serious events
Other events: 62 other events
Deaths: 0 deaths
Liposomal Doxorubicin
Serious events: 23 serious events
Other events: 60 other events
Deaths: 0 deaths
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
Serious events: 14 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olaratumab and Liposomal Doxorubicin
n=62 participants at risk
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin
n=61 participants at risk
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=28 participants at risk
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/62 • Number of events 1
|
1.6%
1/61 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Cardiac disorders
Coronary artery stenosis
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
2/62 • Number of events 4
|
3.3%
2/61 • Number of events 2
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/62
|
4.9%
3/61 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/62
|
4.9%
3/61 • Number of events 4
|
0.00%
0/28
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/62 • Number of events 1
|
3.3%
2/61 • Number of events 2
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/62 • Number of events 4
|
0.00%
0/61
|
0.00%
0/28
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/62
|
3.3%
2/61 • Number of events 2
|
0.00%
0/28
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.8%
3/62 • Number of events 3
|
3.3%
2/61 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Proctitis
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/62 • Number of events 1
|
6.6%
4/61 • Number of events 4
|
0.00%
0/28
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
3/62 • Number of events 3
|
4.9%
3/61 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Chills
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
General disorders
Disease progression
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
General disorders
Extravasation
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
General disorders
Infusion site erythema
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
General disorders
Mucosal inflammation
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Pyrexia
|
3.2%
2/62 • Number of events 2
|
0.00%
0/61
|
7.1%
2/28 • Number of events 2
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Bacillus infection
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Cellulitis
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Device related infection
|
3.2%
2/62 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Febrile infection
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Infection
|
3.2%
2/62 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/62
|
3.3%
2/61 • Number of events 2
|
0.00%
0/28
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Urosepsis
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Infections and infestations
Viral infection
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/62
|
1.6%
1/61 • Number of events 2
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Incorrect drug administration duration
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Medication error
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.6%
1/62 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
3/62 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Nervous system disorders
Syncope
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Psychiatric disorders
Bradyphrenia
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Renal and urinary disorders
Hydronephrosis
|
1.6%
1/62 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Renal and urinary disorders
Renal failure acute
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/62
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
2/62 • Number of events 2
|
6.6%
4/61 • Number of events 4
|
0.00%
0/28
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
Other adverse events
| Measure |
Olaratumab and Liposomal Doxorubicin
n=62 participants at risk
20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
|
Liposomal Doxorubicin
n=61 participants at risk
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
Upon disease progression the participant had the option to receive Olaratumab monotherapy.
|
Liposomal Doxorubicin: Optional Olaratumab Monotherapy
n=28 participants at risk
40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.1%
10/62 • Number of events 21
|
21.3%
13/61 • Number of events 23
|
21.4%
6/28 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
6/62 • Number of events 10
|
3.3%
2/61 • Number of events 2
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.5%
4/62 • Number of events 5
|
0.00%
0/61
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.8%
16/62 • Number of events 67
|
13.1%
8/61 • Number of events 23
|
7.1%
2/28 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
1/62 • Number of events 1
|
4.9%
3/61 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
22.6%
14/62 • Number of events 18
|
9.8%
6/61 • Number of events 8
|
17.9%
5/28 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
24.2%
15/62 • Number of events 22
|
41.0%
25/61 • Number of events 35
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.5%
4/62 • Number of events 4
|
8.2%
5/61 • Number of events 6
|
7.1%
2/28 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.1%
10/62 • Number of events 11
|
11.5%
7/61 • Number of events 8
|
7.1%
2/28 • Number of events 3
|
|
Gastrointestinal disorders
Ascites
|
19.4%
12/62 • Number of events 17
|
9.8%
6/61 • Number of events 9
|
17.9%
5/28 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
51.6%
32/62 • Number of events 40
|
39.3%
24/61 • Number of events 33
|
25.0%
7/28 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
30.6%
19/62 • Number of events 28
|
21.3%
13/61 • Number of events 16
|
17.9%
5/28 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
8.1%
5/62 • Number of events 5
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
Dyspepsia
|
12.9%
8/62 • Number of events 14
|
11.5%
7/61 • Number of events 7
|
25.0%
7/28 • Number of events 7
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
4/62 • Number of events 5
|
4.9%
3/61 • Number of events 5
|
0.00%
0/28
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
2/62 • Number of events 2
|
6.6%
4/61 • Number of events 5
|
0.00%
0/28
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.3%
7/62 • Number of events 7
|
9.8%
6/61 • Number of events 7
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
56.5%
35/62 • Number of events 61
|
63.9%
39/61 • Number of events 61
|
46.4%
13/28 • Number of events 16
|
|
Gastrointestinal disorders
Odynophagia
|
1.6%
1/62 • Number of events 2
|
6.6%
4/61 • Number of events 4
|
0.00%
0/28
|
|
Gastrointestinal disorders
Stomatitis
|
37.1%
23/62 • Number of events 40
|
26.2%
16/61 • Number of events 34
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
33.9%
21/62 • Number of events 41
|
29.5%
18/61 • Number of events 33
|
35.7%
10/28 • Number of events 12
|
|
General disorders
Asthenia
|
12.9%
8/62 • Number of events 11
|
18.0%
11/61 • Number of events 21
|
14.3%
4/28 • Number of events 6
|
|
General disorders
Early satiety
|
4.8%
3/62 • Number of events 3
|
6.6%
4/61 • Number of events 4
|
0.00%
0/28
|
|
General disorders
Fatigue
|
53.2%
33/62 • Number of events 64
|
44.3%
27/61 • Number of events 50
|
17.9%
5/28 • Number of events 6
|
|
General disorders
Mucosal inflammation
|
19.4%
12/62 • Number of events 19
|
24.6%
15/61 • Number of events 38
|
7.1%
2/28 • Number of events 3
|
|
General disorders
Oedema peripheral
|
16.1%
10/62 • Number of events 13
|
19.7%
12/61 • Number of events 16
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Pyrexia
|
12.9%
8/62 • Number of events 15
|
11.5%
7/61 • Number of events 7
|
10.7%
3/28 • Number of events 3
|
|
Infections and infestations
Candidiasis
|
6.5%
4/62 • Number of events 4
|
0.00%
0/61
|
0.00%
0/28
|
|
Infections and infestations
Oral candidiasis
|
3.2%
2/62 • Number of events 3
|
3.3%
2/61 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
3/62 • Number of events 4
|
6.6%
4/61 • Number of events 5
|
7.1%
2/28 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
24.2%
15/62 • Number of events 23
|
4.9%
3/61 • Number of events 5
|
10.7%
3/28 • Number of events 3
|
|
Investigations
Haemoglobin decreased
|
11.3%
7/62 • Number of events 8
|
6.6%
4/61 • Number of events 4
|
7.1%
2/28 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
4.8%
3/62 • Number of events 6
|
8.2%
5/61 • Number of events 5
|
0.00%
0/28
|
|
Investigations
Weight decreased
|
14.5%
9/62 • Number of events 10
|
6.6%
4/61 • Number of events 4
|
3.6%
1/28 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
9.7%
6/62 • Number of events 27
|
4.9%
3/61 • Number of events 3
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.2%
15/62 • Number of events 31
|
21.3%
13/61 • Number of events 19
|
35.7%
10/28 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
11.3%
7/62 • Number of events 7
|
3.3%
2/61 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/62
|
6.6%
4/61 • Number of events 5
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.1%
5/62 • Number of events 8
|
11.5%
7/61 • Number of events 8
|
14.3%
4/28 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.9%
8/62 • Number of events 15
|
9.8%
6/61 • Number of events 8
|
7.1%
2/28 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.7%
11/62 • Number of events 13
|
11.5%
7/61 • Number of events 8
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.8%
16/62 • Number of events 18
|
14.8%
9/61 • Number of events 12
|
17.9%
5/28 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.3%
7/62 • Number of events 14
|
4.9%
3/61 • Number of events 3
|
10.7%
3/28 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.5%
4/62 • Number of events 4
|
0.00%
0/61
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
4/62 • Number of events 5
|
14.8%
9/61 • Number of events 9
|
3.6%
1/28 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
16.1%
10/62 • Number of events 12
|
16.4%
10/61 • Number of events 13
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
16.1%
10/62 • Number of events 12
|
4.9%
3/61 • Number of events 6
|
0.00%
0/28
|
|
Nervous system disorders
Headache
|
19.4%
12/62 • Number of events 18
|
11.5%
7/61 • Number of events 8
|
21.4%
6/28 • Number of events 7
|
|
Nervous system disorders
Lethargy
|
9.7%
6/62 • Number of events 10
|
6.6%
4/61 • Number of events 6
|
0.00%
0/28
|
|
Nervous system disorders
Neuropathy peripheral
|
8.1%
5/62 • Number of events 6
|
3.3%
2/61 • Number of events 4
|
0.00%
0/28
|
|
Nervous system disorders
Paraesthesia
|
4.8%
3/62 • Number of events 4
|
9.8%
6/61 • Number of events 7
|
0.00%
0/28
|
|
Nervous system disorders
Tremor
|
6.5%
4/62 • Number of events 4
|
0.00%
0/61
|
0.00%
0/28
|
|
Psychiatric disorders
Anxiety
|
11.3%
7/62 • Number of events 7
|
9.8%
6/61 • Number of events 6
|
0.00%
0/28
|
|
Psychiatric disorders
Insomnia
|
8.1%
5/62 • Number of events 5
|
4.9%
3/61 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Hydronephrosis
|
1.6%
1/62 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
7.1%
2/28 • Number of events 3
|
|
Renal and urinary disorders
Pollakiuria
|
6.5%
4/62 • Number of events 5
|
3.3%
2/61 • Number of events 2
|
0.00%
0/28
|
|
Renal and urinary disorders
Proteinuria
|
11.3%
7/62 • Number of events 10
|
3.3%
2/61 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/62
|
0.00%
0/61
|
7.1%
2/28 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
10/62 • Number of events 10
|
11.5%
7/61 • Number of events 7
|
7.1%
2/28 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.1%
10/62 • Number of events 11
|
16.4%
10/61 • Number of events 12
|
14.3%
4/28 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.1%
5/62 • Number of events 5
|
4.9%
3/61 • Number of events 4
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.7%
6/62 • Number of events 11
|
6.6%
4/61 • Number of events 4
|
7.1%
2/28 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.1%
10/62 • Number of events 11
|
14.8%
9/61 • Number of events 10
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister
|
11.3%
7/62 • Number of events 11
|
11.5%
7/61 • Number of events 11
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.9%
8/62 • Number of events 11
|
16.4%
10/61 • Number of events 11
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.3%
7/62 • Number of events 7
|
13.1%
8/61 • Number of events 10
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/62
|
0.00%
0/61
|
7.1%
2/28 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.9%
21/62 • Number of events 54
|
44.3%
27/61 • Number of events 60
|
3.6%
1/28 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
3/62 • Number of events 3
|
8.2%
5/61 • Number of events 5
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.7%
24/62 • Number of events 37
|
23.0%
14/61 • Number of events 34
|
14.3%
4/28 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
6.5%
4/62 • Number of events 4
|
3.3%
2/61 • Number of events 2
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.8%
3/62 • Number of events 4
|
9.8%
6/61 • Number of events 11
|
0.00%
0/28
|
|
Vascular disorders
Flushing
|
6.5%
4/62 • Number of events 4
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
|
Vascular disorders
Hypertension
|
6.5%
4/62 • Number of events 4
|
4.9%
3/61 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
|
Vascular disorders
Hypotension
|
6.5%
4/62 • Number of events 5
|
1.6%
1/61 • Number of events 1
|
0.00%
0/28
|
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