Trial Outcomes & Findings for A Study of Olaratumab in Soft Tissue Sarcoma (NCT NCT01185964)

Last Updated: 2017-04-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

148 participants

Primary outcome timeframe

Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)

Results posted on

2017-04-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Phase 1b: Olaratumab + Doxorubicin 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	Phase 2: Olaratumab + Doxorubicin 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	Phase 2: Doxorubicin 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Phase 1b and Phase 2 STARTED	15	66	67	0
Phase 1b and Phase 2 Received at Least 1 Dose of Study Drug	15	64	65	0
Phase 1b and Phase 2 COMPLETED	13	56	58	0
Phase 1b and Phase 2 NOT COMPLETED	2	10	9	0
Optional Olaratumab Monotherapy on Dox STARTED	0	0	0	30
Optional Olaratumab Monotherapy on Dox COMPLETED	0	0	0	25
Optional Olaratumab Monotherapy on Dox NOT COMPLETED	0	0	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Olaratumab + Doxorubicin 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	Phase 2: Olaratumab + Doxorubicin 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	Phase 2: Doxorubicin 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Phase 1b and Phase 2 Withdrawal by Subject	1	6	2	0
Phase 1b and Phase 2 Other Therapy Started	0	3	3	0
Phase 1b and Phase 2 Participant was beyond maximum weight	0	0	1	0
Phase 1b and Phase 2 Adverse Event	1	0	2	0
Phase 1b and Phase 2 Off Treatment but alive and on study	0	1	1	0
Optional Olaratumab Monotherapy on Dox Withdrawal by Subject	0	0	0	2
Optional Olaratumab Monotherapy on Dox Adverse Event	0	0	0	1
Optional Olaratumab Monotherapy on Dox On Study Treatment	0	0	0	2

Baseline Characteristics

A Study of Olaratumab in Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Olaratumab + Doxorubicin n=15 Participants 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	Phase 2: Olaratumab + Doxorubicin n=66 Participants 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	Phase 2: Doxorubicin n=67 Participants 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 n=148 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 13.16 • n=5 Participants	56.8 years STANDARD_DEVIATION 12.53 • n=7 Participants	55.3 years STANDARD_DEVIATION 12.96 • n=5 Participants	56.7 years STANDARD_DEVIATION 10.62 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	40 Participants n=7 Participants	34 Participants n=5 Participants	82 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	26 Participants n=7 Participants	33 Participants n=5 Participants	66 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	60 Participants n=7 Participants	64 Participants n=5 Participants	138 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	55 Participants n=7 Participants	60 Participants n=5 Participants	127 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	66 participants n=7 Participants	67 participants n=5 Participants	148 participants n=4 Participants

PRIMARY outcome

Timeframe: Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)

Population: 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.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=66 Participants 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.	Phase 2: Doxorubicin n=67 Participants 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Progression-free Survival (PFS)	6.6 Month Interval 4.1 to 8.3	4.1 Month Interval 2.8 to 5.4	—

PRIMARY outcome

Timeframe: Baseline Up to 30 Months

Population: All participants in Phase 1b.

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.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=15 Participants 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.	Phase 2: Doxorubicin 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
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 Any AE	14 participants	—	—
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 Any SAE	7 participants	—	—

SECONDARY outcome

Timeframe: Baseline, Up to 30 Months

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

A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=64 Participants 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.	Phase 2: Doxorubicin n=65 Participants 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression n=30 Participants All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Number of Participants With AEs and SAEs for Phase 2 Portion Any SAE	27 participants	26 participants	9 participants
Number of Participants With AEs and SAEs for Phase 2 Portion Any AE	63 participants	64 participants	24 participants

SECONDARY outcome

Timeframe: Randomization to the Date of Death From Any Cause (Up To 47 Months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=66 Participants 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.	Phase 2: Doxorubicin n=67 Participants 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.	Phase 2: Doxorubicin: Optional Olaratumab After 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 Survival (OS)	26.5 Months Interval 20.9 to 31.7	14.7 Months Interval 9.2 to 17.1	—

SECONDARY outcome

Timeframe: Randomization Until Progressive Disease (Up to 30 Months)

Population: All randomized participants in Phase 2 and optional Olaratumab monotherapy.

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%.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=66 Participants 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.	Phase 2: Doxorubicin n=67 Participants 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression n=30 Participants All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Percentage of Participants With Objective Response (Objective Response Rate)	18.2 percentage of participants Interval 9.8 to 29.6	11.9 percentage of participants Interval 5.3 to 22.2	0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: Randomization Until First Radiographic PD or Death from Any Cause (Up to 3 Months)

(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.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=66 Participants 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.	Phase 2: Doxorubicin n=67 Participants 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Percentage of Participants Who Are Progression-Free (PFS) at 3 Months	69.0 percentage of participants Interval 55.7 to 78.9	59.9 percentage of participants Interval 45.9 to 71.4	—

SECONDARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=60 Participants 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.	Phase 2: Doxorubicin 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab Cycle 1 Day 1 (n=60)	284 nanogram/milliliter (μg/mL ) Geometric Coefficient of Variation 23.3	—	—
Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab Cycle 3 Day 1 (n=30)	404 nanogram/milliliter (μg/mL ) Geometric Coefficient of Variation 31.6	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion

Population: 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.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=52 Participants 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.	Phase 2: Doxorubicin 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab Cycle 1 Day 8 (n=52)	66.5 μg/mL Geometric Coefficient of Variation 40.4	—	—
PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab Cycle 3 Day 8 (n=29)	123 μg/mL Geometric Coefficient of Variation 39.6	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion

Population: 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.

AUCτ = area under the concentration versus time curve during one dosing interval with a measurable concentration.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=7 Participants 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.	Phase 2: Doxorubicin 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab Cycle 1 Day 8 (n=7)	39200 microgram•hour/milliliter (μg•h/mL) Geometric Coefficient of Variation 29.0	—	—
PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab Cycle 3 Day 8 (n=4)	47300 microgram•hour/milliliter (μg•h/mL) Geometric Coefficient of Variation 35.0	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion

Population: 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.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=7 Participants 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.	Phase 2: Doxorubicin 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab Cycle 1 Day 8 (n=7)	6.70 Days Interval 4.32 to 9.55	—	—
PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab Cycle 3 Day 8 (n=2)	9.80 Days Interval 6.67 to 14.4	—	—

SECONDARY outcome

Timeframe: Baseline, Up to 30 Months

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

Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.

Outcome measures

Outcome measures
Measure	Phase 2: Olaratumab + Doxorubicin n=11 Participants 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.	Phase 2: Doxorubicin n=58 Participants 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.	Phase 2: Doxorubicin: Optional Olaratumab After Progression n=16 Participants All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
Percentage of Participants With Anti-Olaratumab Antibody Assessment	9.1 percentage of participants	5.2 percentage of participants	6.3 percentage of participants

Adverse Events

Phase 1b: Olaratumab + Doxorubicin

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Phase 2: Olaratumab + Doxorubicin

Serious events: 27 serious events

Other events: 63 other events

Deaths: 0 deaths

Phase 2: Doxorubicin

Serious events: 26 serious events

Other events: 64 other events

Deaths: 0 deaths

Phase 2: Doxorubicin: Optional Olaratumab After Progression

Serious events: 9 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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