Trial · NCT02659020
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
NCT02659020, Phase 1, Phase 2, Completed, Eli Lilly and Company; results first posted 2021-10-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma. Trials, record NCT02659020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02659020
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
- NCT number
- NCT02659020
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 310 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Olaratumab, Gemcitabine, Docetaxel, Placebo
- First posted
- 2016-01-20
- Last updated
- 2022-05-09
- Other registries' IDs
- eudract:2015-001316-34
- Results first posted
- 2021-10-11
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) | Cycle 1 (Up To 21 Days) | A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Febrile neutropenia with documented Grade ≥3 infection or sepsis 2. Grade 4 neutropenia lasting 7 days or longer. 3. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage. 4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea that can be controlled with optimal medical management within 48 hours. |
| Primary | Phase 2: Overall Survival (OS) (Olaratumab-Naive) | Baseline to Date of Death Due to Any Cause (Up To 38 Months) | OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact. |
| Secondary | Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | Pre-dose, 5 minutes (min), 1, 4, 4.5, 24, 96, 168, 336 hours (h) post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8 | Cmax of Olaratumab. |
| Secondary | Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab | Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1 | Cmin of Olaratumab. |
| Secondary | Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab | Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8 | T1/2 of Olaratumab. |
| Secondary | Phase 1b/2: PK: Cmax of Gemcitabine | Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion) | Cmax of Gemcitabine. |
| Secondary | Phase 1b/2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of Gemcitabine | Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion) | AUC\[0-∞\] of Gemcitabine |
| Secondary | Phase 1b/2: PK: Cmax of Docetaxel | 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8 | Cmax of Docetaxel. |
| Secondary | Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Docetaxel | 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8 | AUC \[0-∞\] of Docetaxel. |
| Secondary | Phase 1b/2: Population PK: Clearance of Olaratumab | Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8 | Population PK: Clearance of Olaratumab |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) | Cycle 1 (Up To 21 Days) | Phase 1b: All participants who received at least one dose of Olaratumab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Survival (OS) (Olaratumab-Naive) | Baseline to Date of Death Due to Any Cause (Up To 38 Months) | Phase 2: All randomized participants (including the censored participants). Number of participants censored in Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) =30, Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) =28. | Months | MEDIAN |
| SECONDARY | Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | Pre-dose, 5 minutes (min), 1, 4, 4.5, 24, 96, 168, 336 hours (h) post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8 | Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data. | micrograms per milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab | Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1 | Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab | Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8 | Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data. | days | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b/2: PK: Cmax of Gemcitabine | Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion) | Phase 1b/2: All participants who received at least one dose of Gemcitabine and had evaluable PK data. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b/2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of Gemcitabine | Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion) | Phase 1b/2: Zero participants analysed. Due to short half-life of Gemcitabine, there was insufficient quantifiable data in the elimination phase to calculate AUC\[0-∞\] for any of the participants. | ||
| SECONDARY | Phase 1b/2: PK: Cmax of Docetaxel | 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8 | Phase 1b/2: All participants who received at least one dose of Docetaxel and had evaluable PK data. | Nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Docetaxel | 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8 | Phase 1b/2: All participants who received at least one dose of Docetaxel and had evaluable PK data. For phase 2, zero participants analysed due to data not collected for AUC \[0-∞\] of Docetaxel. | nanograms*hours per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b/2: Population PK: Clearance of Olaratumab | Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8 | Phase 1b/2: All participants who received at least one dose of Olaratumab and had evaluable PK data. Phase 1b and phase 2 participants olaratumab PK data was planned to be pooled for the population PK analysis and compared to a validated PK model to confirm that PK parameters were similar to analyses from previous olaratumab studies. | Liter Per Hour | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | 1 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) | Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 4 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) | Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 3 | Participants | ||
| Phase 2: Overall Survival (OS) (Olaratumab-Naive) | Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) | 16.76 | 95% Confidence Interval 15.28 to 25.40 | Months | |
| Phase 2: Overall Survival (OS) (Olaratumab-Naive) | Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) | 18.04 | 95% Confidence Interval 13.17 to 22.90 | Months | |
| Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | Cycle 1 (Day 1) | 432 | Geometric Coefficient of Variation 24 | micrograms per milliliter (μg/mL) |
| Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | Cycle 1 (Day 1) | 572 | Geometric Coefficient of Variation 25 | micrograms per milliliter (μg/mL) |
| Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | Cycle 1 (Day 8) | 460 | Geometric Coefficient of Variation 25 | micrograms per milliliter (μg/mL) |
| Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | Phase 1b: Cohort 2 Overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | Cycle 1 (Day 8) | 697 | Geometric Coefficient of Variation 20 | micrograms per milliliter (μg/mL) |
| Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | Cycle 3 (Day 1) | 523 | Geometric Coefficient of Variation 38 | micrograms per milliliter (μg/mL) |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | 21 | |
| Overall Study | STARTED | Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 18 | |
| Overall Study | STARTED | Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 15 | |
| Overall Study | STARTED | Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) | 81 | |
| Overall Study | STARTED | Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) | 46 | |
| Overall Study | STARTED | Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) | 86 | |
| Overall Study | STARTED | Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) | 43 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | 21 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 18 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 15 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events2,065
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: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | 13 | 21 | 42 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 12 | 18 | 54 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 9 | 15 | 24 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) | 43 | 81 | 168 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) | 33 | 45 | 145 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) | 47 | 86 | 147 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) | 20 | 43 | 57 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | 0 | 21 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 0 | 18 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 0 | 15 | 0 |
1 to 10 of 2,065Source ClinicalTrials.gov
See all 2,065 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | 15 | 21 |
| Total, all-cause mortality | Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 11 | 18 |
| Total, all-cause mortality | Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 12 | 15 |
| Total, all-cause mortality | Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) | 54 | 81 |
| Total, all-cause mortality | Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) | 28 | 45 |
| Total, all-cause mortality | Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) | 58 | 86 |
| Total, all-cause mortality | Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) | 28 | 43 |
| Total, other adverse events | Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel | 21 | 21 |
| Total, other adverse events | Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 18 | 18 |
| Total, other adverse events | Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel | 15 | 15 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) vs Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated): Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies |
Source 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.
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