---
title: A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma
nct_id: NCT03283696
overall_status: COMPLETED
phase: PHASE1
sponsor: Eli Lilly and Company
study_type: INTERVENTIONAL
primary_condition: Soft Tissue Sarcoma
countries: United States, Germany, Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03283696.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03283696"
ct_last_update_post_date: 2020-09-10
last_seen_at: "2026-05-12T06:14:12.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma

**Official Title:** A Phase 1b Study of Olaratumab, Doxorubicin and Ifosfamide in the Treatment of Patients With Advanced or Metastatic Soft Tissue Sarcoma

**NCT ID:** [NCT03283696](https://clinicaltrials.gov/study/NCT03283696)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Eli Lilly and Company
- **Conditions:** Soft Tissue Sarcoma
- **Start Date:** 2017-10-18
- **Completion Date:** 2019-08-25
- **CT.gov Last Update:** 2020-09-10

## Brief Summary

The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Have a histological diagnosis of advanced STS (by local pathology review), for which treatment with doxorubicin, ifosfamide and mesna is deemed appropriate by the investigator.
* Have measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Have adequate hematologic, organ and coagulation function within 2 weeks (14 days) prior to enrollment.
* Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale.
* Have received no prior lines of systemic therapy and are suitable to receive doxorubicin, ifosfamide and mesna. All previous anticancer treatments must have completed ≥3 weeks (21 days) prior to the first dose of study treatment.
* Have left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to enrollment.
* Have resolution of Adverse Events (AEs), with the exception of alopecia, and of all clinically significant toxic effects of prior locoregional therapy, surgery or radiotherapy to ≤Grade 1, by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.
* Have sufficient available material from archived formalin-fixed paraffin-embedded tumor tissue for biomarker-related studies. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.
* If male, must be sterile or agree to use an effective method of contraception or a highly effective method of contraception during the study and for at least 12 weeks following the last dose of study treatment.
* If female and of child-bearing potential, must:

  1. have a negative serum pregnancy test at the time of enrollment,
  2. have a negative urine pregnancy test within 24 hours prior to the first dose of study treatment, and
  3. agree to use a highly effective method of contraception during the study and for 3 months following the last dose of study treatment.
* Have a life expectancy of at least 3 months, in the opinion of the investigator.

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have participated within the past 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
* Have previously completed or withdrawn from any study investigating olaratumab.
* Have received prior treatment with olaratumab, doxorubicin, or ifosfamide, or have participated in other trials investigating olaratumab.
* Have received prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.
* Have known urinary outflow obstruction, or inflammation of the urinary bladder (cystitis).
* Are diagnosed with gastrointestinal stromal tumor or Kaposi sarcoma.
* Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of CNS metastasis (previously treated with curative intent \[for example, stereotactic radiation or surgery\]) that has not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and/or anticonvulsants are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis.
* Have a history of another primary malignancy, with the exception of:

  1. curatively treated non-melanomatous skin cancer
  2. curatively treated cervical carcinoma in situ
* Have an active fungal, bacterial and/or known viral infection including human immunodeficiency virus or viral (A, B, or C) hepatitis (screening is not required).
* Have Grade 3 or 4 peripheral neuropathy per NCI-CTCAE Version 4.0.
* Have a serious cardiac condition.
* Have a resting heart rate of \>100 beats per minute (bpm).
* Have a Fridericia's QT corrected interval (QTcF) interval of \>450 milliseconds (msec) for males and \>470 msec for females on screening electrocardiogram (ECG) utilizing Fridericia's correction.
* Have uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics.
* Have a psychiatric illness/social situation that would limit compliance with study requirements.
* Have electively planned or will require major surgery during the course of the study.
* Are females who are pregnant or breastfeeding.
```

## Arms

- **Olaratumab + Doxorubicin + Ifosfamide + Mesna** (EXPERIMENTAL) — Olaratumab 15 milligrams per kilogram (mg/kg) on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin and ifosfamide was administered. When the safety of the 15-mg/kg dose of olaratumab was established, a 20-mg/kg loading dose cycle of olaratumab on Days 1 and 8 of a 21-day cycle in Cycle 1 only, followed by 15 mg/kg on Days 1 and 8 of subsequent cycles in combination with doxorubicin and ifosfamide plus mesna, was administered.

## Interventions

- **Olaratumab** (DRUG) — Administered IV
- **Doxorubicin** (DRUG) — Administered IV
- **Ifosfamide** (DRUG) — Administered IV
- **Mesna** (DRUG) — Administered per standard of care

## Primary Outcomes

- **Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)** _(time frame: Cycle 1 (Up To 24 days))_ — A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the NCI-CTCAE Version 4.0:

1. Grade 3 or 4 febrile neutropenia, or sepsis., or
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 or clinically non-significant laboratory abnormalities.

## Secondary Outcomes

- **Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab** _(time frame: Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara))_
- **PK: Maximum Serum Concentration (Cmax,ss) of Olaratumab at Steady-state** _(time frame: Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara))_
- **PK: Trough Serum Concentration (Cmin)** _(time frame: Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara))_
- **PK: Trough Serum Concentration (Cmin,ss) of Olaratumab at Steady-state** _(time frame: Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara))_
- **Number of Participants With Anti-Olaratumab Antibodies** _(time frame: Baseline through Follow-up (Up To 21 Months))_
- **Objective Response Rate (ORR): Number of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)** _(time frame: Baseline up to Short-Term Follow-Up Period (Up To 21 Months))_
- **Progression Free Survival (PFS)** _(time frame: Baseline to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months))_
- **Duration of Response (DoR)** _(time frame: Date of Complete Response (CR) or Partial Response (PR) to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months))_
- **Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)** _(time frame: Baseline until Disease Progression or Death Due to Any Cause (Up To 21 Months))_
- **Overall Survival (OS)** _(time frame: Baseline to Date of Death Due to Any Cause (Up To 21 Months))_

## Locations (6)

- University of Miami School of Medicine, Miami, Florida, United States
- University of Texas MD Anderson Cancer Center, Houston, Texas, United States
- Universitätsklinikum Essen, Essen, North Rhine-Westphalia, Germany
- HELIOS Klinikum Berlin-Buch, Berlin, Germany
- Istituto Nazionale dei Tumori, Milan, Lombardy, Italy
- Università degli Studi di Catania - Azienda Policlinico, Catania, Italy

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of miami school of medicine|miami|florida|united states` — added _(2026-05-12)_
- `locations.university of texas md anderson cancer center|houston|texas|united states` — added _(2026-05-12)_
- `locations.universitätsklinikum essen|essen|north rhine-westphalia|germany` — added _(2026-05-12)_
- `locations.helios klinikum berlin-buch|berlin||germany` — added _(2026-05-12)_
- `locations.istituto nazionale dei tumori|milan|lombardy|italy` — added _(2026-05-12)_
- `locations.università degli studi di catania - azienda policlinico|catania||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03283696.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03283696*  
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