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A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma

This study is currently recruiting participants.
Verified October 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02783599
First Posted: May 26, 2016
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).

Condition Intervention Phase
Soft Tissue Sarcoma Drug: Olaratumab Drug: Doxorubicin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients With Potentially Resectable Soft Tissue Sarcoma Treated With Olaratumab Monotherapy Followed by Olaratumab Plus Doxorubicin Combination Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood [ Time Frame: Baseline, End of Cycle 1 (21 days) ]
  • Change from Baseline in Expression of Platelet-Derived Growth Factor Receptor (PDGFR) Alpha, PDGFR Beta and Canonical Ligands in Tumor Tissue [ Time Frame: Baseline, End of Cycle 1 (21 days) ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death from Any Cause (Estimated up to 24 Months) ]
  • Objective Response Rate (ORR): Percent of Participants with Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Measured Progressive Disease (Estimated up to 6 Months) ]
  • Disease Control Rate (DCR): Percent of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline to Measured Progressive Disease (Estimated up to 6 Months) ]
  • Resectability Rate [ Time Frame: Cycle 1 through Cycle 7 (Estimated up to 6 Months) ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Estimated up to 8 Months) ]
  • Number of Participants with Anti-Olaratumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Estimated up to 8 Months) ]

Estimated Enrollment: 40
Study Start Date: October 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olaratumab + Doxorubicin

Cycle 1: Olaratumab given intravenously (IV) on day 1 and day 8 (21 day cycle).

Cycle 2: Olaratumab given IV on day 1 and day 8 plus doxorubicin given IV on day 1 (21 day cycle).

Cycle 3 through Cycle 7: Olaratumab given IV on day 1 and day 8 plus doxorubicin given IV on day 1 (21 day cycles).

Drug: Olaratumab
Administered IV
Other Name: LY3012207
Drug: Doxorubicin
Administered IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy.
  • Have consented to undergo mandatory serial peripheral whole blood and tumor tissue sampling.

Exclusion Criteria:

  • Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have 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 received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783599


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, California
USC/Norris Comp Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact    323-865-3538      
Principal Investigator: James Hu         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact    203-737-1600      
Principal Investigator: Hari Deshpande         
United States, Florida
All Children's Hospital Not yet recruiting
Saint Petersburg, Florida, United States, 33701
Contact    727-767-2423      
Principal Investigator: Peter Shaw         
Moffitt Cancer Center & Research Inst Recruiting
Tampa, Florida, United States, 33612
Contact    813-745-3242      
Principal Investigator: Andrew Brohl         
United States, Kansas
Kansas City Cancer Center Recruiting
Overland Park, Kansas, United States, 66210
Contact    913-234-0400      
Principal Investigator: Benjamin Powers         
United States, Missouri
Washington University Medical Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact    314-747-8475      
Principal Investigator: Brian Van Tine         
United States, North Carolina
Levine Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28203
Contact    704-381-6810      
Principal Investigator: Chad Jacobsen         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact    615-936-1762      
Principal Investigator: Scott Borinstein         
United States, Texas
Mary Crowley Cancer Research Not yet recruiting
Dallas, Texas, United States, 75230
Contact    972-566-3090      
Principal Investigator: Maurizio Ghisoli         
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Lyon, France, 69373
Contact: Eli Lilly and Company         
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Milano, Italy, 20133
Contact: Eli Lilly and Company         
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Barcelona, Spain, 08025
Contact: Eli Lilly and Company         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Sevilla, Spain, 41013
Contact: Eli Lilly and Company         
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
London, United Kingdom, SW3 6JJ
Contact: Eli Lilly and Company         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02783599     History of Changes
Other Study ID Numbers: 15840
I5B-MC-JGDM ( Other Identifier: Eli Lilly and Company )
2015-005018-31 ( EudraCT Number )
First Submitted: May 24, 2016
First Posted: May 26, 2016
Last Update Posted: October 24, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Olaratumab
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action