Trial · NCT01185964
A Study of Olaratumab in Soft Tissue Sarcoma
NCT01185964, Phase 1, Phase 2, Completed, Eli Lilly and Company; results first posted 2017-04-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Olaratumab in Soft Tissue Sarcoma. Trials, record NCT01185964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01185964
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Olaratumab in Soft Tissue Sarcoma
- NCT number
- NCT01185964
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Sarcoma, Soft Tissue
- Interventions
- Olaratumab, doxorubicin
- First posted
- 2010-08-20
- Last updated
- 2017-04-14
- Results first posted
- 2017-04-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months) | 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. |
| Primary | 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 | Baseline Up to 30 Months | 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. |
| Secondary | Number of Participants With AEs and SAEs for Phase 2 Portion | Baseline, Up to 30 Months | A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. |
| Secondary | Overall Survival (OS) | Randomization to the Date of Death From Any Cause (Up To 47 Months) | 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. |
| Secondary | Percentage of Participants With Objective Response (Objective Response Rate) | Randomization Until Progressive Disease (Up to 30 Months) | 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%. |
| Secondary | Percentage of Participants Who Are Progression-Free (PFS) at 3 Months | 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. |
| Secondary | Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab | 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 | |
| Secondary | PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab | Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion | |
| Secondary | PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab | Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion | AUCτ = area under the concentration versus time curve during one dosing interval with a measurable concentration. |
| Secondary | PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab | Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months) | 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. | Month | MEDIAN |
| PRIMARY | 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 | Baseline Up to 30 Months | All participants in Phase 1b. | participants | NUMBER |
| SECONDARY | Number of Participants With AEs and SAEs for Phase 2 Portion | Baseline, Up to 30 Months | All randomized participants who received at least 1 dose of study drug in Phase 2 and optional Olaratumab monotherapy. | participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Randomization to the Date of Death From Any Cause (Up To 47 Months) | 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. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (Objective Response Rate) | Randomization Until Progressive Disease (Up to 30 Months) | All randomized participants in Phase 2 and optional Olaratumab monotherapy. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Are Progression-Free (PFS) at 3 Months | Randomization Until First Radiographic PD or Death from Any Cause (Up to 3 Months) | 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. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab | 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 | 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. | nanogram/milliliter (μg/mL ) | GEOMETRIC_MEAN |
| SECONDARY | PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab | Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion | 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. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab | Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion | 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. | microgram•hour/milliliter (μg•h/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab | Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion | 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. | Days | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Phase 2: Olaratumab + Doxorubicin | 6.6 | 95% Confidence Interval 4.1 to 8.3 | Month | |
| Progression-free Survival (PFS) | Phase 2: Doxorubicin | 4.1 | 95% Confidence Interval 2.8 to 5.4 | Month | |
| 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 | Phase 1b: Olaratumab + Doxorubicin | 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 | Phase 1b: Olaratumab + Doxorubicin | Any SAE | 7 | participants | |
| Number of Participants With AEs and SAEs for Phase 2 Portion | Phase 2: Olaratumab + Doxorubicin | Any AE | 63 | participants | |
| Number of Participants With AEs and SAEs for Phase 2 Portion | Phase 2: Doxorubicin | Any AE | 64 | participants | |
| Number of Participants With AEs and SAEs for Phase 2 Portion | Phase 2: Doxorubicin: Optional Olaratumab After Progression | Any AE | 24 | participants | |
| Number of Participants With AEs and SAEs for Phase 2 Portion | Phase 2: Olaratumab + Doxorubicin | Any SAE | 27 | participants | |
| Number of Participants With AEs and SAEs for Phase 2 Portion | Phase 2: Doxorubicin | Any SAE | 26 | participants | |
| Number of Participants With AEs and SAEs for Phase 2 Portion | Phase 2: Doxorubicin: Optional Olaratumab After Progression | Any SAE | 9 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b and Phase 2 | STARTED | Phase 1b: Olaratumab + Doxorubicin | 15 | |
| Phase 1b and Phase 2 | STARTED | Phase 2: Olaratumab + Doxorubicin | 66 | |
| Phase 1b and Phase 2 | STARTED | Phase 2: Doxorubicin | 67 | |
| Phase 1b and Phase 2 | STARTED | Phase 2: Doxorubicin: Optional Olaratumab After Progression | 0 | |
| Phase 1b and Phase 2 | Received at Least 1 Dose of Study Drug | Phase 1b: Olaratumab + Doxorubicin | 15 | |
| Phase 1b and Phase 2 | Received at Least 1 Dose of Study Drug | Phase 2: Olaratumab + Doxorubicin | 64 | |
| Phase 1b and Phase 2 | Received at Least 1 Dose of Study Drug | Phase 2: Doxorubicin | 65 | |
| Phase 1b and Phase 2 | Received at Least 1 Dose of Study Drug | Phase 2: Doxorubicin: Optional Olaratumab After Progression | 0 | |
| Phase 1b and Phase 2 | COMPLETED | Phase 1b: Olaratumab + Doxorubicin | 13 | |
| Phase 1b and Phase 2 | COMPLETED | Phase 2: Olaratumab + Doxorubicin | 56 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events756
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 | Phase 1b: Olaratumab + Doxorubicin | 11 | 15 | 42 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Olaratumab + Doxorubicin | 26 | 64 | 87 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Doxorubicin | 24 | 65 | 31 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Doxorubicin: Optional Olaratumab After Progression | 5 | 30 | 12 |
| other | Leukocytosis | Blood and lymphatic system disorders | Phase 1b: Olaratumab + Doxorubicin | 0 | 15 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Phase 2: Olaratumab + Doxorubicin | 1 | 64 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Phase 2: Doxorubicin | 3 | 65 | 3 |
| other | Leukocytosis | Blood and lymphatic system disorders | Phase 2: Doxorubicin: Optional Olaratumab After Progression | 2 | 30 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Olaratumab + Doxorubicin | 7 | 15 | 15 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 2: Olaratumab + Doxorubicin | 16 | 64 | 47 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b: Olaratumab + Doxorubicin | ||
| Total, all-cause mortality | Phase 2: Olaratumab + Doxorubicin | ||
| Total, all-cause mortality | Phase 2: Doxorubicin | ||
| Total, all-cause mortality | Phase 2: Doxorubicin: Optional Olaratumab After Progression | ||
| Total, other adverse events | Phase 1b: Olaratumab + Doxorubicin | 14 | 15 |
| Total, other adverse events | Phase 2: Olaratumab + Doxorubicin | 63 | 64 |
| Total, other adverse events | Phase 2: Doxorubicin | 64 | 65 |
| Total, other adverse events | Phase 2: Doxorubicin: Optional Olaratumab After Progression | 24 | 30 |
| Total, serious adverse events | Phase 1b: Olaratumab + Doxorubicin | 7 | 15 |
| Total, serious adverse events | Phase 2: Olaratumab + Doxorubicin | 27 | 64 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27291997 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01185964
GET https://conductscience.org/api/trials/v1/NCT01185964/results?page=2