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

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ClinicalTrials.gov Identifier: NCT02783599
Recruitment Status : Active, not recruiting
First Posted : May 26, 2016
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Soft Tissue Sarcoma Drug: Olaratumab Drug: Doxorubicin Radiation: External Beam Radiotherapy Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Non-Randomized
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
Actual Study Start Date : October 11, 2016
Actual Primary Completion Date : July 4, 2018
Estimated Study Completion Date : June 14, 2019


Arm Intervention/treatment
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

Experimental: Olaratumab + Radiotherapy Addendum
Olaratumab given IV on day 1 and day 8 (21 day cycle) concurrently with radiotherapy. Currently enrolling participants.
Drug: Olaratumab
Administered IV
Other Name: LY3012207

Radiation: External Beam Radiotherapy



Primary Outcome Measures :
  1. Change from Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood [ Time Frame: Baseline, End of Cycle 1 (21 days) ]
  2. 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 :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death from Any Cause (Estimated up to 24 Months) ]
  2. 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) ]
  3. 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) ]
  4. Resectability Rate [ Time Frame: Cycle 1 through Cycle 7 (Estimated up to 6 Months) ]
  5. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Estimated up to 8 Months) ]
  6. Number of Participants with Anti-Olaratumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Estimated up to 8 Months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
  • For radiotherapy addendum only: Have a histologically confirmed diagnosis of STS of the extremities, Grade 2 or 3, >5 centimeters, for which olaratumab and radiotherapy would be appropriate therapy. Participants with Kaposi's sarcoma, GIST or myxoid liposarcoma will be excluded.
  • 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.
  • For radiotherapy addendum only: Have received previous radiotherapy in the primary tumor lesion and/or prior treatment with olaratumab or has participated in a prior olaratumab trial.

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


Locations
United States, California
USC/Norris Comp Cancer Center
Los Angeles, California, United States, 90033
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Moffitt Cancer Center & Research Inst
Tampa, Florida, United States, 33612
United States, Kansas
Kansas City Cancer Center
Overland Park, Kansas, United States, 66210
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
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.
Lyon, France, 69373
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.
Milano, Italy, 20133
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.
Barcelona, Spain, 08025
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.
Sevilla, Spain, 41013
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.
London, United Kingdom, SW3 6JJ
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

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 Posted: May 26, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 1, 2018

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