A Study of Olaratumab in Soft Tissue Sarcoma

• ClinicalTrials.gov Identifier: NCT01185964
• Recruitment Status: Completed
• First Posted: August 20, 2010
• Results First Posted: April 14, 2017
• Last Update Posted: April 14, 2017
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sarcoma, Soft Tissue
• Interventions: Biological: Olaratumab; Drug: doxorubicin
• Enrollment: 148

Participant Flow

Recruitment Details
Pre-assignment Details	Participants who had evidence of progressive disease (PD), died, or received optional olaratumab treatment on the doxorubicin (dox) monotherapy arm were considered to have completed the study. This includes participants who discontinued treatment due to non-PD reasons, but had PD at End of Study.

Arm/Group Title	Phase 1b: Olaratumab + Doxorubicin	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin	Phase 2: Doxorubicin: Optional Olaratumab After Progression
Arm/Group Description	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.	All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Period Title: Phase 1b and Phase 2
Started	15	66	67	0
Received at Least 1 Dose of Study Drug	15	64	65	0
Completed	13	56	58	0
Not Completed	2	10	9	0
Reason Not Completed
Withdrawal by Subject	1	6	2	0
Other Therapy Started	0	3	3	0
Participant was beyond maximum weight	0	0	1	0
Adverse Event	1	0	2	0
Off Treatment but alive and on study	0	1	1	0
Period Title: Optional Olaratumab Monotherapy on Dox
Started	0	0	0	30 [1]
Completed	0	0	0	25
Not Completed	0	0	0	5
Reason Not Completed
Withdrawal by Subject	0	0	0	2
Adverse Event	0	0	0	1
On Study Treatment	0	0	0	2
[1] Participants with disease progression after treatment received olaratumab.

Baseline Characteristics

Arm/Group Title		Phase 1b: Olaratumab + Doxorubicin	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin	Total
Arm/Group Description		All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.	Total of all reporting groups
Overall Number of Baseline Participants		15	66	67	148
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	66 participants	67 participants	148 participants
		48.7 (13.16)	56.8 (12.53)	55.3 (12.96)	56.7 (10.62)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	66 participants	67 participants	148 participants
	Female	8 53.3%	40 60.6%	34 50.7%	82 55.4%
	Male	7 46.7%	26 39.4%	33 49.3%	66 44.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	66 participants	67 participants	148 participants
	Hispanic or Latino	1 6.7%	6 9.1%	2 3.0%	9 6.1%
	Not Hispanic or Latino	14 93.3%	60 90.9%	64 95.5%	138 93.2%
	Unknown or Not Reported	0 0.0%	0 0.0%	1 1.5%	1 0.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	66 participants	67 participants	148 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	2 3.0%	2 3.0%	4 2.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 1.5%	0 0.0%	1 0.7%
	Black or African American	2 13.3%	6 9.1%	5 7.5%	13 8.8%
	White	12 80.0%	55 83.3%	60 89.6%	127 85.8%
	More than one race	1 6.7%	2 3.0%	0 0.0%	3 2.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	15 participants	66 participants	67 participants	148 participants
		15	66	67	148

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS)
Description	PFS is measured from randomization until the first radiographic documentation of progression of disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause. Participants who died without PD was considered to have progressed on the day of death. The following censoring rules applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization. Participants were censored at the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last adequate radiographic visit. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.
Time Frame	Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.

Arm/Group Title	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8 Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle Doxorubicin 75 mg/m2 by IV on day 1 of the 21-day cycle.	All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.
Overall Number of Participants Analyzed	66	67
Median (95% Confidence Interval); Unit of Measure: Month
	6.6; (4.1 to 8.3)	4.1; (2.8 to 5.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 2: Olaratumab + Doxorubicin, Phase 2: Doxorubicin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0615
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.672
	Confidence Interval	(2-Sided) 95%; 0.442 to 1.021
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Number of Participants With Treatment Related Adverse Events (TEAE), Adverse Events (AE) or Serious Adverse Events (SAE) for Safety for the Phase 1b Portion of the Study
Description	All Phase 1b participants who experienced at least 1 TEAE in the Phase 1b portion of the study. Adverse Event with missing relationship to study is counted as related. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Time Frame	Baseline Up to 30 Months

Outcome Measure Data

Analysis Population Description

All participants in Phase 1b.

Arm/Group Title	Phase 1b: Olaratumab + Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8 Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.
Overall Number of Participants Analyzed	15
Measure Type: Number; Unit of Measure: participants
Any AE	14
Any SAE	7

3. Secondary Outcome

Title	Number of Participants With AEs and SAEs for Phase 2 Portion
Description	A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Time Frame	Baseline, Up to 30 Months

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug in Phase 2 and optional Olaratumab monotherapy.

Arm/Group Title	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin	Phase 2: Doxorubicin: Optional Olaratumab After Progression
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle.	All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.	All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Overall Number of Participants Analyzed	64	65	30
Measure Type: Number; Unit of Measure: participants
Any AE	63	64	24
Any SAE	27	26	9

4. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the date of randomization to the date of death from any cause. Reasons for censoring OS were that participant was known to be alive, participant was lost to follow up during the study or participant withdrew consent to follow up.
Time Frame	Randomization to the Date of Death From Any Cause (Up To 47 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored participants = Phase 2 Olaratumab + Doxorubicin = 27 and Doxorubicin = 15.

Arm/Group Title	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.
Overall Number of Participants Analyzed	66	67
Median (95% Confidence Interval); Unit of Measure: Months
	26.5; (20.9 to 31.7)	14.7; (9.2 to 17.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phase 2: Olaratumab + Doxorubicin, Phase 2: Doxorubicin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.463
	Confidence Interval	(2-Sided) 95%; 0.301 to 0.710
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants With Objective Response (Objective Response Rate)
Description	Objective Response Rate (ORR) is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.
Time Frame	Randomization Until Progressive Disease (Up to 30 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants in Phase 2 and optional Olaratumab monotherapy.

Arm/Group Title	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin	Phase 2: Doxorubicin: Optional Olaratumab After Progression
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.	All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Overall Number of Participants Analyzed	66	67	30
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	18.2; (9.8 to 29.6)	11.9; (5.3 to 22.2)	0; (0.0 to 11.6)

6. Secondary Outcome

Title	Percentage of Participants Who Are Progression-Free (PFS) at 3 Months
Description	(PFS) rate is defined as the percentage of participants that are alive and progression-free 3 months after randomization. PFS is measured from randomization until the first radiographic progressive disease as defined by RECIST (version 1.1) or death from any cause. Participants who died without PD were considered to have progressed on the day of death. Censoring applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization or the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit. If participant started new treatment before PD, participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.
Time Frame	Randomization Until First Radiographic PD or Death from Any Cause (Up to 3 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.

Arm/Group Title	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.
Overall Number of Participants Analyzed	66	67
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	69.0; (55.7 to 78.9)	59.9; (45.9 to 71.4)

7. Secondary Outcome

Title	Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab
Description	[Not Specified]
Time Frame	Cycle 1 Day 1: Preinfusion, End of Infusion,1hr,48hr,72hr,168 hr Post infusion; Cycle 3 Day 1:Preinfusion, End of Infusion,1hr,24hr,48hr,72hr,168hr Post Infusion

Outcome Measure Data

Analysis Population Description

All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.

Arm/Group Title	Phase 1b and Phase 2 Olaratumab + Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle
Overall Number of Participants Analyzed	60
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram/milliliter (μg/mL )
Cycle 1 Day 1 (n=60)	284; (23.3%)
Cycle 3 Day 1 (n=30)	404; (31.6%)

8. Secondary Outcome

Title	PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab
Description	[Not Specified]
Time Frame	Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion

Outcome Measure Data

Analysis Population Description

All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.

Arm/Group Title	Phase 1b and Phase 2: Olaratumab + Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle
Overall Number of Participants Analyzed	52
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg/mL
Cycle 1 Day 8 (n=52)	66.5; (40.4%)
Cycle 3 Day 8 (n=29)	123; (39.6%)

9. Secondary Outcome

Title	PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab
Description	AUCτ = area under the concentration versus time curve during one dosing interval with a measurable concentration.
Time Frame	Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion

Outcome Measure Data

Analysis Population Description

All participants who had evaluable PK data in Phase1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.

Arm/Group Title	Phase 1b and Phase 2: Olaratumab + Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle
Overall Number of Participants Analyzed	7
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: microgram•hour/milliliter (μg•h/mL)
Cycle 1 Day 8 (n=7)	39200; (29.0%)
Cycle 3 Day 8 (n=4)	47300; (35.0%)

10. Secondary Outcome

Title	PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab
Description	[Not Specified]
Time Frame	Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion

Outcome Measure Data

Analysis Population Description

All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.

Arm/Group Title	Phase 1b and Phase 2: Olaratumab + Doxorubicin
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle
Overall Number of Participants Analyzed	7
Geometric Mean (Full Range); Unit of Measure: Days
Cycle 1 Day 8 (n=7)	6.70; (4.32 to 9.55)
Cycle 3 Day 8 (n=2)	9.80; (6.67 to 14.4)

11. Secondary Outcome

Title	Percentage of Participants With Anti-Olaratumab Antibody Assessment
Description	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.
Time Frame	Baseline, Up to 30 Months

Outcome Measure Data

Analysis Population Description

All participants who had baseline and post baseline anti-olaratumab antibodies.

Arm/Group Title	Phase 1b: Olaratumab + Doxorubicin	Phase 2: Olaratumab + Doxorubicin	Phase 2: Doxorubicin: Optional Olaratumab After Progression
Arm/Group Description:	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle	All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle	All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Overall Number of Participants Analyzed	11	58	16
Measure Type: Number; Unit of Measure: percentage of participants
	9.1	5.2	6.3

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	All participants who received at least one dose of study drug.
Arm/Group Title	Phase 1b: Olaratumab + Doxorubicin		Phase 2: Olaratumab + Doxorubicin		Phase 2: Doxorubicin		Phase 2: Doxorubicin: Optional Olaratumab After Progression
Arm/Group Description	All cycles are 21 days. Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle		All cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle		All cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.		All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
All-Cause Mortality
	Phase 1b: Olaratumab + Doxorubicin		Phase 2: Olaratumab + Doxorubicin		Phase 2: Doxorubicin		Phase 2: Doxorubicin: Optional Olaratumab After Progression
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events
	Phase 1b: Olaratumab + Doxorubicin		Phase 2: Olaratumab + Doxorubicin		Phase 2: Doxorubicin		Phase 2: Doxorubicin: Optional Olaratumab After Progression
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/15 (46.67%)		27/64 (42.19%)		26/65 (40.00%)		9/30 (30.00%)
Blood and lymphatic system disorders
Anaemia † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Febrile neutropenia † 1	2/15 (13.33%)	3	8/64 (12.50%)	8	8/65 (12.31%)	9	0/30 (0.00%)	0
Neutropenia † 1	0/15 (0.00%)	0	3/64 (4.69%)	5	3/65 (4.62%)	3	0/30 (0.00%)	0
Thrombocytopenia † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	2/65 (3.08%)	2	0/30 (0.00%)	0
Cardiac disorders
Cardiac arrest † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	0/65 (0.00%)	0	1/30 (3.33%)	1
Sinus bradycardia † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Endocrine disorders
Inappropriate antidiuretic hormone secretion † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Gastrointestinal disorders
Abdominal pain † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	1/65 (1.54%)	1	0/30 (0.00%)	0
Abdominal pain upper † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Ascites † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Constipation † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	1/65 (1.54%)	2	0/30 (0.00%)	0
Diarrhoea † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Dry mouth † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Gastric perforation † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Gastric ulcer † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Gastrointestinal haemorrhage † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	1/30 (3.33%)	1
Ileus † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Nausea † 1	2/15 (13.33%)	3	1/64 (1.56%)	1	2/65 (3.08%)	2	0/30 (0.00%)	0
Small intestinal obstruction † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	2/65 (3.08%)	2	0/30 (0.00%)	0
Upper gastrointestinal haemorrhage † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	0/65 (0.00%)	0	1/30 (3.33%)	1
Vomiting † 1	3/15 (20.00%)	4	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
General disorders
Asthenia † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Death † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Device breakage † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Disease progression † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	0/65 (0.00%)	0	1/30 (3.33%)	1
Non-cardiac chest pain † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	1/65 (1.54%)	1	0/30 (0.00%)	0
Pyrexia † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	2	0/30 (0.00%)	0
Hepatobiliary disorders
Hepatic haemorrhage † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Immune system disorders
Hypersensitivity † 1	0/15 (0.00%)	0	2/64 (3.13%)	2	0/65 (0.00%)	0	0/30 (0.00%)	0
Infections and infestations
Actinomycotic skin infection † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Cellulitis † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	2/65 (3.08%)	2	0/30 (0.00%)	0
Clostridium difficile colitis † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Influenza † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	0/65 (0.00%)	0	1/30 (3.33%)	1
Neutropenic sepsis † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	2/65 (3.08%)	2	0/30 (0.00%)	0
Sepsis † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Septic shock † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Sinusitis † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Skin infection † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Staphylococcal bacteraemia † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Urinary tract infection † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	3/65 (4.62%)	3	0/30 (0.00%)	0
Injury, poisoning and procedural complications
Anastomotic ulcer † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Fracture † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Infusion related reaction † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	0/65 (0.00%)	0	1/30 (3.33%)	1
Procedural pain † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Wound necrosis † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Investigations
Blood creatinine increased † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Troponin increased † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
White blood cell count decreased † 1	0/15 (0.00%)	0	1/64 (1.56%)	2	0/65 (0.00%)	0	0/30 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Dehydration † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Hypocalcaemia † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Hypokalaemia † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	1/65 (1.54%)	1	0/30 (0.00%)	0
Hypomagnesaemia † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Back pain † 1	2/15 (13.33%)	2	2/64 (3.13%)	2	0/65 (0.00%)	0	2/30 (6.67%)	2
Musculoskeletal chest pain † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Pain in extremity † 1	0/15 (0.00%)	0	1/64 (1.56%)	2	0/65 (0.00%)	0	1/30 (3.33%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	0/65 (0.00%)	0	1/30 (3.33%)	1
Nervous system disorders
Cerebrovascular accident † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Convulsion † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Syncope † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Renal and urinary disorders
Renal failure acute † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	1/30 (3.33%)	1
Obstructive airways disorder † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Pleural effusion † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	1/65 (1.54%)	1	0/30 (0.00%)	0
Pleuritic pain † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Pneumonia aspiration † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Pneumothorax † 1	0/15 (0.00%)	0	2/64 (3.13%)	2	2/65 (3.08%)	2	0/30 (0.00%)	0
Pulmonary embolism † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Respiratory failure † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	1/65 (1.54%)	1	0/30 (0.00%)	0
Vascular disorders
Hypotension † 1	0/15 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Phase 1b: Olaratumab + Doxorubicin		Phase 2: Olaratumab + Doxorubicin		Phase 2: Doxorubicin		Phase 2: Doxorubicin: Optional Olaratumab After Progression
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/15 (93.33%)		63/64 (98.44%)		64/65 (98.46%)		24/30 (80.00%)
Blood and lymphatic system disorders
Anaemia † 1	11/15 (73.33%)	42	26/64 (40.63%)	87	24/65 (36.92%)	31	5/30 (16.67%)	12
Leukocytosis † 1	0/15 (0.00%)	0	1/64 (1.56%)	1	3/65 (4.62%)	3	2/30 (6.67%)	2
Leukopenia † 1	7/15 (46.67%)	15	16/64 (25.00%)	47	5/65 (7.69%)	11	0/30 (0.00%)	0
Neutropenia † 1	5/15 (33.33%)	8	28/64 (43.75%)	83	13/65 (20.00%)	18	0/30 (0.00%)	0
Thrombocytopenia † 1	5/15 (33.33%)	7	14/64 (21.88%)	56	10/65 (15.38%)	14	0/30 (0.00%)	0
Cardiac disorders
Left ventricular dysfunction † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Sinus tachycardia † 1	2/15 (13.33%)	2	1/64 (1.56%)	1	3/65 (4.62%)	3	2/30 (6.67%)	2
Tachycardia † 1	1/15 (6.67%)	1	4/64 (6.25%)	5	3/65 (4.62%)	3	1/30 (3.33%)	1
Ear and labyrinth disorders
Deafness unilateral † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Eye disorders
Dry eye † 1	0/15 (0.00%)	0	7/64 (10.94%)	8	2/65 (3.08%)	2	0/30 (0.00%)	0
Lacrimation increased † 1	1/15 (6.67%)	1	4/64 (6.25%)	4	1/65 (1.54%)	1	0/30 (0.00%)	0
Gastrointestinal disorders
Abdominal distension † 1	1/15 (6.67%)	1	6/64 (9.38%)	6	1/65 (1.54%)	1	2/30 (6.67%)	2
Abdominal pain † 1	1/15 (6.67%)	1	5/64 (7.81%)	8	5/65 (7.69%)	5	2/30 (6.67%)	2
Abdominal pain lower † 1	1/15 (6.67%)	1	3/64 (4.69%)	4	1/65 (1.54%)	1	0/30 (0.00%)	0
Abdominal pain upper † 1	1/15 (6.67%)	1	8/64 (12.50%)	10	2/65 (3.08%)	3	1/30 (3.33%)	1
Anal fissure † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Constipation † 1	4/15 (26.67%)	7	21/64 (32.81%)	38	21/65 (32.31%)	26	3/30 (10.00%)	4
Diarrhoea † 1	4/15 (26.67%)	5	22/64 (34.38%)	35	15/65 (23.08%)	21	5/30 (16.67%)	7
Dry mouth † 1	1/15 (6.67%)	1	6/64 (9.38%)	7	6/65 (9.23%)	6	1/30 (3.33%)	1
Dyspepsia † 1	0/15 (0.00%)	0	6/64 (9.38%)	6	1/65 (1.54%)	1	0/30 (0.00%)	0
Dysphagia † 1	0/15 (0.00%)	0	1/64 (1.56%)	2	4/65 (6.15%)	7	0/30 (0.00%)	0
Gastrooesophageal reflux disease † 1	1/15 (6.67%)	1	4/64 (6.25%)	5	4/65 (6.15%)	4	1/30 (3.33%)	1
Nausea † 1	8/15 (53.33%)	12	47/64 (73.44%)	99	33/65 (50.77%)	55	6/30 (20.00%)	7
Proctalgia † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	1/65 (1.54%)	2	1/30 (3.33%)	2
Rectal haemorrhage † 1	1/15 (6.67%)	1	2/64 (3.13%)	3	0/65 (0.00%)	0	0/30 (0.00%)	0
Stomatitis † 1	4/15 (26.67%)	4	11/64 (17.19%)	13	10/65 (15.38%)	14	1/30 (3.33%)	1
Vomiting † 1	5/15 (33.33%)	5	29/64 (45.31%)	36	12/65 (18.46%)	16	5/30 (16.67%)	7
General disorders
Asthenia † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Catheter site rash † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Chills † 1	1/15 (6.67%)	1	4/64 (6.25%)	4	2/65 (3.08%)	2	3/30 (10.00%)	3
Fatigue † 1	9/15 (60.00%)	16	44/64 (68.75%)	83	45/65 (69.23%)	73	6/30 (20.00%)	9
Mucosal inflammation † 1	2/15 (13.33%)	2	17/64 (26.56%)	28	12/65 (18.46%)	28	0/30 (0.00%)	0
Non-cardiac chest pain † 1	0/15 (0.00%)	0	8/64 (12.50%)	8	3/65 (4.62%)	3	1/30 (3.33%)	1
Oedema peripheral † 1	1/15 (6.67%)	1	10/64 (15.63%)	14	7/65 (10.77%)	10	4/30 (13.33%)	5
Pyrexia † 1	2/15 (13.33%)	2	15/64 (23.44%)	18	12/65 (18.46%)	17	3/30 (10.00%)	3
Hepatobiliary disorders
Portal vein thrombosis † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Infections and infestations
Cellulitis † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Sinusitis † 1	1/15 (6.67%)	1	2/64 (3.13%)	2	4/65 (6.15%)	4	0/30 (0.00%)	0
Upper respiratory tract infection † 1	1/15 (6.67%)	1	8/64 (12.50%)	8	4/65 (6.15%)	4	1/30 (3.33%)	1
Urinary tract infection † 1	1/15 (6.67%)	1	3/64 (4.69%)	3	3/65 (4.62%)	3	2/30 (6.67%)	2
Vaginal infection † 1	1/8 (12.50%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Injury, poisoning and procedural complications
Fracture † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Incision site complication † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Infusion related reaction † 1	2/15 (13.33%)	2	2/64 (3.13%)	5	0/65 (0.00%)	0	1/30 (3.33%)	1
Tooth fracture † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Wound complication † 1	1/15 (6.67%)	1	2/64 (3.13%)	2	0/65 (0.00%)	0	0/30 (0.00%)	0
Investigations
Activated partial thromboplastin time prolonged † 1	3/15 (20.00%)	5	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Aspartate aminotransferase increased † 1	2/15 (13.33%)	3	3/64 (4.69%)	3	1/65 (1.54%)	1	0/30 (0.00%)	0
Blood alkaline phosphatase increased † 1	1/15 (6.67%)	1	2/64 (3.13%)	2	1/65 (1.54%)	1	1/30 (3.33%)	1
Ejection fraction decreased † 1	1/15 (6.67%)	1	5/64 (7.81%)	5	4/65 (6.15%)	4	0/30 (0.00%)	0
International normalised ratio increased † 1	4/15 (26.67%)	5	2/64 (3.13%)	2	1/65 (1.54%)	1	0/30 (0.00%)	0
Lymphocyte count decreased † 1	0/15 (0.00%)	0	5/64 (7.81%)	18	2/65 (3.08%)	6	0/30 (0.00%)	0
Neutrophil count decreased † 1	0/15 (0.00%)	0	12/64 (18.75%)	25	9/65 (13.85%)	14	0/30 (0.00%)	0
Platelet count decreased † 1	0/15 (0.00%)	0	6/64 (9.38%)	11	3/65 (4.62%)	3	0/30 (0.00%)	0
Weight decreased † 1	0/15 (0.00%)	0	7/64 (10.94%)	8	7/65 (10.77%)	7	2/30 (6.67%)	2
White blood cell count decreased † 1	0/15 (0.00%)	0	12/64 (18.75%)	46	7/65 (10.77%)	13	0/30 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite † 1	6/15 (40.00%)	6	19/64 (29.69%)	22	13/65 (20.00%)	13	3/30 (10.00%)	4
Dehydration † 1	0/15 (0.00%)	0	6/64 (9.38%)	6	6/65 (9.23%)	9	2/30 (6.67%)	4
Hyperglycaemia † 1	1/15 (6.67%)	1	4/64 (6.25%)	10	0/65 (0.00%)	0	1/30 (3.33%)	1
Hyperkalaemia † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	1/65 (1.54%)	1	2/30 (6.67%)	2
Hypoalbuminaemia † 1	3/15 (20.00%)	4	4/64 (6.25%)	4	3/65 (4.62%)	4	1/30 (3.33%)	1
Hypocalcaemia † 1	2/15 (13.33%)	2	5/64 (7.81%)	5	2/65 (3.08%)	2	0/30 (0.00%)	0
Hypokalaemia † 1	2/15 (13.33%)	2	8/64 (12.50%)	10	5/65 (7.69%)	9	1/30 (3.33%)	1
Hypomagnesaemia † 1	2/15 (13.33%)	2	5/64 (7.81%)	6	1/65 (1.54%)	1	1/30 (3.33%)	1
Hyponatraemia † 1	1/15 (6.67%)	1	3/64 (4.69%)	4	6/65 (9.23%)	6	1/30 (3.33%)	1
Hypophosphataemia † 1	2/15 (13.33%)	3	2/64 (3.13%)	2	2/65 (3.08%)	5	0/30 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia † 1	3/15 (20.00%)	3	8/64 (12.50%)	8	2/65 (3.08%)	3	3/30 (10.00%)	3
Back pain † 1	1/15 (6.67%)	2	10/64 (15.63%)	17	6/65 (9.23%)	6	2/30 (6.67%)	2
Bone pain † 1	0/15 (0.00%)	0	5/64 (7.81%)	5	1/65 (1.54%)	1	0/30 (0.00%)	0
Muscle spasms † 1	1/15 (6.67%)	2	10/64 (15.63%)	20	1/65 (1.54%)	1	0/30 (0.00%)	0
Musculoskeletal chest pain † 1	1/15 (6.67%)	2	8/64 (12.50%)	10	1/65 (1.54%)	2	1/30 (3.33%)	1
Musculoskeletal pain † 1	0/15 (0.00%)	0	4/64 (6.25%)	5	2/65 (3.08%)	2	1/30 (3.33%)	2
Myalgia † 1	1/15 (6.67%)	1	6/64 (9.38%)	8	2/65 (3.08%)	2	1/30 (3.33%)	2
Pain in extremity † 1	1/15 (6.67%)	1	15/64 (23.44%)	19	1/65 (1.54%)	1	2/30 (6.67%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Tumour pain † 1	1/15 (6.67%)	1	2/64 (3.13%)	2	3/65 (4.62%)	3	1/30 (3.33%)	2
Nervous system disorders
Dizziness † 1	1/15 (6.67%)	1	6/64 (9.38%)	7	10/65 (15.38%)	12	5/30 (16.67%)	7
Dysgeusia † 1	0/15 (0.00%)	0	6/64 (9.38%)	7	3/65 (4.62%)	3	0/30 (0.00%)	0
Headache † 1	2/15 (13.33%)	2	13/64 (20.31%)	15	6/65 (9.23%)	7	1/30 (3.33%)	1
Hypoaesthesia † 1	1/15 (6.67%)	1	2/64 (3.13%)	2	3/65 (4.62%)	3	1/30 (3.33%)	1
Lethargy † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	1/65 (1.54%)	1	0/30 (0.00%)	0
Neuropathy peripheral † 1	2/15 (13.33%)	2	8/64 (12.50%)	8	5/65 (7.69%)	5	2/30 (6.67%)	2
Parosmia † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Peripheral motor neuropathy † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Peripheral sensory neuropathy † 1	1/15 (6.67%)	1	3/64 (4.69%)	5	1/65 (1.54%)	1	0/30 (0.00%)	0
Psychiatric disorders
Anxiety † 1	3/15 (20.00%)	3	7/64 (10.94%)	8	2/65 (3.08%)	2	0/30 (0.00%)	0
Confusional state † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	2/65 (3.08%)	2	0/30 (0.00%)	0
Depression † 1	1/15 (6.67%)	1	4/64 (6.25%)	4	2/65 (3.08%)	2	0/30 (0.00%)	0
Hallucination † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Insomnia † 1	1/15 (6.67%)	1	8/64 (12.50%)	9	6/65 (9.23%)	6	2/30 (6.67%)	2
Renal and urinary disorders
Chromaturia † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Pollakiuria † 1	1/15 (6.67%)	1	4/64 (6.25%)	4	0/65 (0.00%)	0	0/30 (0.00%)	0
Urinary incontinence † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	2/65 (3.08%)	2	0/30 (0.00%)	0
Reproductive system and breast disorders
Pelvic pain † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Vaginal haemorrhage † 1	0/8 (0.00%)	0	3/40 (7.50%)	3	0/34 (0.00%)	0	0/14 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough † 1	2/15 (13.33%)	2	14/64 (21.88%)	16	12/65 (18.46%)	17	3/30 (10.00%)	4
Dyspnoea † 1	4/15 (26.67%)	5	11/64 (17.19%)	14	12/65 (18.46%)	13	0/30 (0.00%)	0
Dyspnoea exertional † 1	2/15 (13.33%)	3	0/64 (0.00%)	0	2/65 (3.08%)	3	0/30 (0.00%)	0
Epistaxis † 1	0/15 (0.00%)	0	4/64 (6.25%)	4	2/65 (3.08%)	2	0/30 (0.00%)	0
Nasal congestion † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	2/65 (3.08%)	2	0/30 (0.00%)	0
Oropharyngeal pain † 1	2/15 (13.33%)	2	12/64 (18.75%)	15	3/65 (4.62%)	4	1/30 (3.33%)	1
Rhinitis allergic † 1	2/15 (13.33%)	2	1/64 (1.56%)	1	1/65 (1.54%)	1	0/30 (0.00%)	0
Rhinorrhoea † 1	0/15 (0.00%)	0	5/64 (7.81%)	5	2/65 (3.08%)	2	0/30 (0.00%)	0
Upper-airway cough syndrome † 1	2/15 (13.33%)	2	1/64 (1.56%)	1	0/65 (0.00%)	0	0/30 (0.00%)	0
Wheezing † 1	1/15 (6.67%)	1	2/64 (3.13%)	2	1/65 (1.54%)	2	0/30 (0.00%)	0
Skin and subcutaneous tissue disorders
Alopecia † 1	6/15 (40.00%)	6	33/64 (51.56%)	41	26/65 (40.00%)	32	2/30 (6.67%)	2
Dry skin † 1	2/15 (13.33%)	2	4/64 (6.25%)	5	4/65 (6.15%)	4	1/30 (3.33%)	1
Erythema † 1	1/15 (6.67%)	1	3/64 (4.69%)	3	1/65 (1.54%)	1	0/30 (0.00%)	0
Nail discolouration † 1	1/15 (6.67%)	1	3/64 (4.69%)	3	1/65 (1.54%)	1	0/30 (0.00%)	0
Pain of skin † 1	1/15 (6.67%)	2	1/64 (1.56%)	1	0/65 (0.00%)	0	1/30 (3.33%)	1
Rash † 1	0/15 (0.00%)	0	2/64 (3.13%)	2	1/65 (1.54%)	1	2/30 (6.67%)	2
Rash erythematous † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	2/65 (3.08%)	2	0/30 (0.00%)	0
Rash macular † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	1/65 (1.54%)	1	1/30 (3.33%)	1
Rash maculo-papular † 1	1/15 (6.67%)	1	1/64 (1.56%)	1	2/65 (3.08%)	2	0/30 (0.00%)	0
Skin hyperpigmentation † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Vascular disorders
Embolism † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
Hypotension † 1	0/15 (0.00%)	0	4/64 (6.25%)	4	4/65 (6.15%)	4	0/30 (0.00%)	0
Jugular vein thrombosis † 1	1/15 (6.67%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0	0/30 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Chief Medical Officer
• Organization: Eli Lilly and Company
• Phone: 800-545-5979

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. doi: 10.1016/S0140-6736(16)30587-6. Epub 2016 Jun 9. Erratum In: Lancet. 2016 Jul 30;388(10043):464.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01185964
• Other Study ID Numbers: 14055; I5B-IE-JGDG ( Other Identifier: Eli Lilly and Company ); CP15-0806 ( Other Identifier: ImClone Systems )
• First Submitted: August 19, 2010
• First Posted: August 20, 2010
• Results First Submitted: November 18, 2016
• Results First Posted: April 14, 2017
• Last Update Posted: April 14, 2017