Olaratumab for Soft Tissue Sarcoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Soft Tissue SarcomaOlaratumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if adding olaratumab to doxorubicin helps people with advanced soft tissue sarcoma more than just using doxorubicin alone.

Eligible Conditions
  • Soft Tissue Sarcoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)

Day 30
Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate
Day 30
PK: Volume of Distribution at Steady State (Vss) of Olaratumab: Mean Parameter Estimate
Month 4
Duration of Overall Response (DoR)
Month 8
Duration of Disease Control (DDC)
Month 8
Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
Month 5
Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
Month 8
Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Month 8
Overall Survival (OS)
Overall Survival (OS) Leiomyosarcoma (LMS)
Month 8
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
Month 45
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
Month 8
Progression Free Survival (PFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Doxorubicin + Olaratumab
1 of 2
Doxorubicin + Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

509 Total Participants · 2 Treatment Groups

Primary Treatment: Olaratumab · Has Placebo Group · Phase 3

Doxorubicin + OlaratumabExperimental Group · 2 Interventions: Olaratumab, Doxorubicin · Intervention Types: Drug, Drug
Doxorubicin + PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Doxorubicin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaratumab
FDA approved
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: randomization (cycle 1) through follow-up (up to 35.8 months)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,467 Previous Clinical Trials
3,135,048 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,259 Previous Clinical Trials
369,044 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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References