Trial · NCT02451943
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
NCT02451943, Phase 3, Completed, Eli Lilly and Company; results first posted 2019-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma. Trials, record NCT02451943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02451943
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
- NCT number
- NCT02451943
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 509 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Olaratumab, Doxorubicin, Placebo
- First posted
- 2015-05-22
- Last updated
- 2025-07-15
- Other registries' IDs
- eudract:2015-000134-30
- Results first posted
- 2019-12-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters. |
| Primary | Overall Survival (OS) Leiomyosarcoma (LMS) | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters. |
| Secondary | Progression Free Survival (PFS) | Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months) | PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression. |
| Secondary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) | ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1. |
| Secondary | Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.5 Months) | DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores | Randomization (Cycle 1) through Follow-up (Up to 35.8 Months) | Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales \[physical, role, cognitive, emotional, and social\]), and 9 symptom subscales \[fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea\]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale. |
| Secondary | Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Randomization through Follow-up (Up to 35.8 Months) | The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores. |
| Secondary | Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" | Randomization through Follow-up (Up to 34.5 Months) | Time to first worsening of the brief pain inventory short form modified (mBPI-sf) "worst pain score" was defined as the time from the date of the first study drug dose (baseline date) to the first date of a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). |
| Secondary | Duration of Overall Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months) | The duration of overall response was defined for each participant with a best response of CR or PR and measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that disease is recurrent or objective disease progression or death due to any cause is observed (taking as reference for PD the smallest measurements recorded on study). |
| Secondary | Duration of Disease Control (DDC) | Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) | Duration of disease control was defined for each participant with a best response of CR, PR, or stable disease (SD) as the time from randomization to the first date of disease progression or death due to any cause. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) | All randomized participants. Censored participants in Doxorubicin + Olaratumab arm = 87 and Doxorubicin + Placebo arm = 91 | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) Leiomyosarcoma (LMS) | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) | All randomized participants with LMS. Censored participants in Doxorubicin + Olaratumab arm = 42 and Doxorubicin + Placebo arm = 40. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months) | All randomized participants. Censored participants in the Doxorubicin + Olaratumab arm = 39 and the Doxorubicin + Placebo arm =34. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.5 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores | Randomization (Cycle 1) through Follow-up (Up to 35.8 Months) | All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period. | Months | MEDIAN |
| SECONDARY | Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Randomization through Follow-up (Up to 35.8 Months) | All randomized participants who had a baseline and a post-baseline measurement. | score on a scale | MEAN |
| SECONDARY | Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) Worst Pain Score | Randomization through Follow-up (Up to 34.5 Months) | All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period. | Months | MEDIAN |
| SECONDARY | Duration of Overall Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months) | All randomized participants who have evaluable DoR data. | Months | MEDIAN |
| SECONDARY | Duration of Disease Control (DDC) | Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) | All randomized participants who had evaluable DDC data. | Months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Doxorubicin + Olaratumab | 20.37 | 95% Confidence Interval 17.84 to 22.90 | Months | |
| Overall Survival (OS) | Doxorubicin + Placebo | 19.75 | 95% Confidence Interval 16.49 to 23.75 | Months | |
| Overall Survival (OS) Leiomyosarcoma (LMS) | Doxorubicin + Olaratumab | 21.55 | 95% Confidence Interval 18.63 to 27.63 | Months | |
| Overall Survival (OS) Leiomyosarcoma (LMS) | Doxorubicin + Placebo | 21.88 | 95% Confidence Interval 17.54 to 25.07 | Months | |
| Progression Free Survival (PFS) | Doxorubicin + Olaratumab | 5.42 | 95% Confidence Interval 4.11 to 6.70 | Months | |
| Progression Free Survival (PFS) | Doxorubicin + Placebo | 6.77 | 95% Confidence Interval 5.49 to 8.08 | Months | |
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) | Doxorubicin + Olaratumab | 14.0 | 95% Confidence Interval 9.7 to 18.2 | percentage of participants | |
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) | Doxorubicin + Placebo | 18.3 | 95% Confidence Interval 13.5 to 23.1 | percentage of participants | |
| Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) | Doxorubicin + Olaratumab | 67.4 | 95% Confidence Interval 61.7 to 73.2 | percentage of participants | |
| Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) | Doxorubicin + Placebo | 75.7 | 95% Confidence Interval 70.4 to 81.0 | percentage of participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxorubicin + Olaratumab | 258 | |
| Overall Study | STARTED | Doxorubicin + Placebo | 251 | |
| Overall Study | Received at Least One Dose of Study Drug | Doxorubicin + Olaratumab | 257 | |
| Overall Study | Received at Least One Dose of Study Drug | Doxorubicin + Placebo | 249 | |
| Overall Study | COMPLETED | Doxorubicin + Olaratumab | 242 | |
| Overall Study | COMPLETED | Doxorubicin + Placebo | 227 | |
| Overall Study | NOT COMPLETED | Doxorubicin + Olaratumab | 16 | |
| Overall Study | NOT COMPLETED | Doxorubicin + Placebo | 24 |
Source ClinicalTrials.gov
Adverse events358
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Doxorubicin + Olaratumab | 115 | 257 | 169 |
| other | Anaemia | Blood and lymphatic system disorders | Doxorubicin + Placebo | 121 | 249 | 230 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Doxorubicin + Olaratumab | 13 | 257 | 13 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Doxorubicin + Placebo | 9 | 249 | 12 |
| other | Leukopenia | Blood and lymphatic system disorders | Doxorubicin + Olaratumab | 14 | 257 | 36 |
| other | Leukopenia | Blood and lymphatic system disorders | Doxorubicin + Placebo | 11 | 249 | 23 |
| other | Neutropenia | Blood and lymphatic system disorders | Doxorubicin + Olaratumab | 59 | 257 | 131 |
| other | Neutropenia | Blood and lymphatic system disorders | Doxorubicin + Placebo | 59 | 249 | 121 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Doxorubicin + Olaratumab | 14 | 257 | 29 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Doxorubicin + Placebo | 19 | 249 | 35 |
1 to 10 of 358Source ClinicalTrials.gov
See all 358 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxorubicin + Olaratumab | 170 | 257 |
| Total, all-cause mortality | Doxorubicin + Placebo | 158 | 249 |
| Total, other adverse events | Doxorubicin + Olaratumab | 248 | 257 |
| Total, other adverse events | Doxorubicin + Placebo | 244 | 249 |
| Total, serious adverse events | Doxorubicin + Olaratumab | 105 | 257 |
| Total, serious adverse events | Doxorubicin + Placebo | 89 | 249 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Doxorubicin + Olaratumab vs Doxorubicin + Placebo: deaths from any cause | Trial comparisons |
| Doxorubicin + Olaratumab vs Doxorubicin + Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02451943
GET https://conductscience.org/api/trials/v1/NCT02451943/results?page=2