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
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
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
Mark “Yes” if the following statements are true for you:References
- Jones, Robin L., Andrew J. Wagner, Akira Kawai, Kazuo Tamura, Ashwin Shahir, Brian A. Van Tine, Javier Martín-Broto, Patrick M. Peterson, Jennifer Wright, and William D. Tap. 2021. “Prospective Evaluation of Doxorubicin Cardiotoxicity in Patients with Advanced Soft-tissue Sarcoma Treated in the ANNOUNCE Phase III Randomized Trial”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-20-4592.
- Tap, William D., Andrew J. Wagner, Patrick Schöffski, Javier Martin-Broto, Anders Krarup-Hansen, Kristen N. Ganjoo, Chueh-Chuan Yen, et al.. 2020. “Effect of Doxorubicin Plus Olaratumab Vs Doxorubicin Plus Placebo on Survival in Patients with Advanced Soft Tissue Sarcomas”. Jama. American Medical Association (AMA). doi:10.1001/jama.2020.1707.
- Tobias, Alexander, Michael P O’brien, and Mark Agulnik. 2017. “Olaratumab for Advanced Soft Tissue Sarcoma”. Expert Review of Clinical Pharmacology. Informa UK Limited. doi:10.1080/17512433.2017.1324295.
- Tobias A, O'brien MP, Agulnik M. Olaratumab for advanced soft tissue sarcoma. Expert Rev Clin Pharmacol. 2017 Jul;10(7):699-705. doi: 10.1080/17512433.2017.1324295. Epub 2017 May 5.
- Tap WD, Wagner AJ, Schoffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Papai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. doi: 10.1001/jama.2020.1707.
- Jones RL, Wagner AJ, Kawai A, Tamura K, Shahir A, Van Tine BA, Martin-Broto J, Peterson PM, Wright J, Tap WD. Prospective Evaluation of Doxorubicin Cardiotoxicity in Patients with Advanced Soft-tissue Sarcoma Treated in the ANNOUNCE Phase III Randomized Trial. Clin Cancer Res. 2021 Jul 15;27(14):3861-3866. doi: 10.1158/1078-0432.CCR-20-4592. Epub 2021 Feb 25.
- 2015. "A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02451943.
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Conditions
Cancer Related
Treatments