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Trial Outcomes & Findings for A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma (NCT NCT02326025)

NCT ID: NCT02326025

Last Updated: 2019-11-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

49 participants

Primary outcome timeframe

Cycle(C)1 and (C)2, Day(D)1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hours (Hrs) Post dose

Results posted on

2019-11-21

Participant Flow

Completers include participants who died or discontinued study treatment due to progressive disease.

Participant milestones

Participant milestones
Measure
Part A
Doxorubicin (Dox) Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.
Part B
Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.
Overall Study
STARTED
25
24
Overall Study
Received at Least 1 Dose of Study Drug
25
24
Overall Study
COMPLETED
20
19
Overall Study
NOT COMPLETED
5
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Part A
Doxorubicin (Dox) Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.
Part B
Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.
Overall Study
Adverse Event
3
0
Overall Study
Physician Decision
1
2
Overall Study
Physician and Participant Decision
1
0
Overall Study
Withdrawal by Subject
0
2
Overall Study
Protocol Violation
0
1

Baseline Characteristics

A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part A
n=25 Participants
Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.
Part B
n=24 Participants
Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.
Total
n=49 Participants
Total of all reporting groups
Age, Continuous
56.7 years
STANDARD_DEVIATION 12.6 • n=99 Participants
56.1 years
STANDARD_DEVIATION 11.2 • n=107 Participants
56.4 years
STANDARD_DEVIATION 11.8 • n=206 Participants
Sex: Female, Male
Female
15 Participants
n=99 Participants
14 Participants
n=107 Participants
29 Participants
n=206 Participants
Sex: Female, Male
Male
10 Participants
n=99 Participants
10 Participants
n=107 Participants
20 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
n=99 Participants
22 Participants
n=107 Participants
46 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
22 Participants
n=99 Participants
22 Participants
n=107 Participants
44 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
25 Participants
n=99 Participants
24 Participants
n=107 Participants
49 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Cycle(C)1 and (C)2, Day(D)1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hours (Hrs) Post dose

Population: All participants who received at least one dose of study drugs and had evaluable PK data.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=22 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
n=24 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
n=21 Participants
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin
2580 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 24
2570 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
2400 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 21
2470 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 20

PRIMARY outcome

Timeframe: C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose

Population: All participants who received at least one dose of study drugs and had evaluable PK data.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=22 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
n=24 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
n=21 Participants
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
PK: Maximum Concentration (Cmax) Doxorubicin
2570 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 47
2330 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 68
2060 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 53
2070 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 60

SECONDARY outcome

Timeframe: C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose

Population: All participants who received at least one dose of study drugs and had evaluable PK data.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=22 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
n=24 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
n=21 Participants
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
PK:Time of Maximum Observed Concentration (Tmax) Doxorubicin
0.30 hour (h)
Interval 0.25 to 0.58
0.31 hour (h)
Interval 0.25 to 0.58
0.33 hour (h)
Interval 0.25 to 0.67
0.33 hour (h)
Interval 0.25 to 0.55

SECONDARY outcome

Timeframe: C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose

Population: All participants who received at least one dose of study drugs and had evaluable PK data.

PK: AUC (0-tLast) with a measurable concentration. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=24 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
n=23 Participants
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
PK: AUC Zero to Time t, Where t is the Last Time Point (0-tLast) Olaratumab
32800 ng∙h/mL
Geometric Coefficient of Variation 21
32000 ng∙h/mL
Geometric Coefficient of Variation 21
53800 ng∙h/mL
Geometric Coefficient of Variation 24
54100 ng∙h/mL
Geometric Coefficient of Variation 20

SECONDARY outcome

Timeframe: C1 D10:Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose

Population: All participants who received at least one dose of study drugs and had evaluable PK data.

PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=24 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
n=23 Participants
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
PK: Cmax Olaratumab
292 ng/mL
Geometric Coefficient of Variation 19
386 ng/mL
Geometric Coefficient of Variation 16
512 ng/mL
Geometric Coefficient of Variation 21
634 ng/mL
Geometric Coefficient of Variation 26

SECONDARY outcome

Timeframe: C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose

Population: All participants who received at least one dose of study drugs and had evaluable PK data.

Tmax times are relative to the start of the approximately 60-minute IV infusion of olaratumab. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=24 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
n=23 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
n=23 Participants
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
PK: Tmax Olaratumab
2.00 h
Interval 1.0 to 23.17
2.79 h
Interval 1.8 to 6.43
1.67 h
Interval 0.05 to 24.1
3.50 h
Interval 1.0 to 6.97

SECONDARY outcome

Timeframe: Preinfusion on Day 1 of Cycles 1 through 3 and Preinfusion on Day 1 of Every Second Cycle Thereafter, Up to 30-Day Follow Up

Population: All participants who received at least one dose of study drug and had evaluable baseline and post-baseline anti-olaratumab antibodies.

The formation of anti-drug antibodies (ADA) was assessed using validated ELISAs, following a 4-tier approach. Both the ADA screening assay and the neutralizing antibody assay were validated in accordance with the US Food and Drug Administration (FDA) Guidance for Industry. Participants who had positive samples for treatment emergence due to being \<4-fold difference from baseline or occurred prior to drug exposure are reported.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=25 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=24 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Percentage of Participants With Olaratumab Antibodies
0 percentage of participants
0 percentage of participants
—
—

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease, Study Discontinuation or Death (Up to 24 Months)

Population: All participants who received at least one dose of study drug and had a post-baseline lesion response.

The percentage of participants with a best overall response achieving CR or PR (ORR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. The methodology for the confidence interval calculation is the "exact F" method.

Outcome measures

Outcome measures
Measure
Part A Doxorubicin Alone
n=25 Participants
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
Part A Doxorubicin + 15 mg/kg Olaratumab
n=24 Participants
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
Part B Doxorubicin Alone
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
Part B Doxorubicin + 20 mg/kg Olaratumab
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
12.0 percentage of participants
Interval 2.5 to 31.2
25.0 percentage of participants
Interval 9.8 to 46.7
—
—

Adverse Events

Part A

Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths

Part B

Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Part A
n=25 participants at risk
Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.
Part B
n=24 participants at risk
Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.
Blood and lymphatic system disorders
Anaemia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Blood and lymphatic system disorders
Febrile neutropenia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Blood and lymphatic system disorders
Leukopenia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Blood and lymphatic system disorders
Neutropenia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Blood and lymphatic system disorders
Thrombocytopenia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Colitis
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Large intestine perforation
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Nausea
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Stomatitis
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Vomiting
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Asthenia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Pyrexia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Immune system disorders
Hypersensitivity
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Abscess
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Gastroenteritis salmonella
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Pneumonia
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Sepsis
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Metabolism and nutrition disorders
Hyperglycaemia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Fistula
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Vascular disorders
Deep vein thrombosis
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Vascular disorders
Embolism venous
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.

Other adverse events

Other adverse events
Measure
Part A
n=25 participants at risk
Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV). Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV. Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.
Part B
n=24 participants at risk
Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV. Olaratumab + Doxorubicin: For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion. Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.
Blood and lymphatic system disorders
Anaemia
40.0%
10/25 • Number of events 11 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
33.3%
8/24 • Number of events 10 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Blood and lymphatic system disorders
Neutropenia
36.0%
9/25 • Number of events 12 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
29.2%
7/24 • Number of events 10 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Blood and lymphatic system disorders
Thrombocytopenia
28.0%
7/25 • Number of events 11 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Cardiac disorders
Palpitations
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Cardiac disorders
Sinus tachycardia
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Eye disorders
Dry eye
8.0%
2/25 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Eye disorders
Eye pain
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Abdominal pain
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
25.0%
6/24 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Abdominal pain upper
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Constipation
36.0%
9/25 • Number of events 9 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
50.0%
12/24 • Number of events 20 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Diarrhoea
24.0%
6/25 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
50.0%
12/24 • Number of events 22 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Dry mouth
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
29.2%
7/24 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Gastritis
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Gastrooesophageal reflux disease
20.0%
5/25 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Nausea
52.0%
13/25 • Number of events 14 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
79.2%
19/24 • Number of events 31 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Stomatitis
20.0%
5/25 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
16.7%
4/24 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Gastrointestinal disorders
Vomiting
20.0%
5/25 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
33.3%
8/24 • Number of events 14 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Asthenia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Chills
12.0%
3/25 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Fatigue
56.0%
14/25 • Number of events 19 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
75.0%
18/24 • Number of events 24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Mucosal inflammation
12.0%
3/25 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
33.3%
8/24 • Number of events 10 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Non-cardiac chest pain
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Oedema
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Oedema peripheral
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
20.8%
5/24 • Number of events 5 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Pyrexia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
16.7%
4/24 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
General disorders
Temperature intolerance
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Candida infection
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Herpes zoster
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Oral candidiasis
12.0%
3/25 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Upper respiratory tract infection
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
20.8%
5/24 • Number of events 8 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Infections and infestations
Urinary tract infection
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Activated partial thromboplastin time prolonged
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Blood creatinine increased
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Ejection fraction decreased
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
International normalised ratio increased
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Lymphocyte count decreased
16.0%
4/25 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Neutrophil count decreased
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Platelet count decreased
12.0%
3/25 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 10 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
Weight decreased
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Investigations
White blood cell count decreased
24.0%
6/25 • Number of events 8 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
16.7%
4/24 • Number of events 9 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Metabolism and nutrition disorders
Decreased appetite
28.0%
7/25 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
33.3%
8/24 • Number of events 9 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Metabolism and nutrition disorders
Dehydration
12.0%
3/25 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Metabolism and nutrition disorders
Hypoalbuminaemia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Metabolism and nutrition disorders
Hypokalaemia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Metabolism and nutrition disorders
Hyponatraemia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Arthralgia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
20.8%
5/24 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Back pain
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
16.7%
4/24 • Number of events 9 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Bone pain
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
16.7%
4/24 • Number of events 5 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Muscle spasms
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Myalgia
24.0%
6/25 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Neck pain
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Musculoskeletal and connective tissue disorders
Pain in extremity
8.0%
2/25 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Nervous system disorders
Dizziness
16.0%
4/25 • Number of events 5 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
29.2%
7/24 • Number of events 10 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Nervous system disorders
Dysgeusia
16.0%
4/25 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
33.3%
8/24 • Number of events 9 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Nervous system disorders
Headache
24.0%
6/25 • Number of events 6 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
16.7%
4/24 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Nervous system disorders
Neuropathy peripheral
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Psychiatric disorders
Anxiety
4.0%
1/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Psychiatric disorders
Depression
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Psychiatric disorders
Insomnia
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Renal and urinary disorders
Dysuria
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Renal and urinary disorders
Pollakiuria
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Renal and urinary disorders
Proteinuria
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Renal and urinary disorders
Urinary incontinence
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Cough
36.0%
9/25 • Number of events 9 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
33.3%
8/24 • Number of events 8 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Dysphonia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
16.0%
4/25 • Number of events 5 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
20.8%
5/24 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Hiccups
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
16.0%
4/25 • Number of events 5 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
4.0%
1/25 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Skin and subcutaneous tissue disorders
Alopecia
28.0%
7/25 • Number of events 7 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
41.7%
10/24 • Number of events 10 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Skin and subcutaneous tissue disorders
Nail discolouration
12.0%
3/25 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Skin and subcutaneous tissue disorders
Pain of skin
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
0.00%
0/24 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Skin and subcutaneous tissue disorders
Rash
12.0%
3/25 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Vascular disorders
Embolism
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
4.2%
1/24 • Number of events 1 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Vascular disorders
Hypertension
8.0%
2/25 • Number of events 2 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
12.5%
3/24 • Number of events 3 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
Vascular disorders
Hypotension
0.00%
0/25 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
8.3%
2/24 • Number of events 4 • From Baseline, to Study Completion (Up to 47 Months)
All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60