NCT02783599

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2016

Geographic Reach
5 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 12, 2019

Completed
Last Updated

August 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

May 24, 2016

Results QC Date

June 28, 2019

Last Update Submit

June 28, 2019

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (3)

  • Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood

    Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously.

    Baseline, End of Cycle 1 (21 days)

  • Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue

    Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα.

    Baseline, End of Cycle 1 (21 days)

  • Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue

    PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β.

    Baseline, End of Cycle 1 (21 days)

Secondary Outcomes (7)

  • Progression Free Survival (PFS)

    Baseline to Objective Progression or Death from Any Cause (Up to 18 Months)

  • Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)

    Baseline to Measured Progressive Disease (Up to 18 Months)

  • Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR

    Baseline to Measured Progressive Disease (Up to 18 Months)

  • Percentage of Participants With Resectable Tumors (Resectability Rate)

    Cycle 1 through Cycle 7 (Up to 6 Months)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy

    Cycle 1 Days 1 and 8: Predose; 5 minutes(m) post-infusion

  • +2 more secondary outcomes

Study Arms (2)

Olaratumab + Doxorubicin

EXPERIMENTAL

Cycle 1: Olaratumab 20 milligram per kilogram (mg/kg) given intravenously (IV) on Day 1 and Day 8 (21 day cycle). Cycle 2: Olaratumab 20 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycle). Cycle 3 through Cycle 7: Olaratumab 15 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycles).

Drug: OlaratumabDrug: Doxorubicin

Olaratumab + Radiotherapy Addendum

EXPERIMENTAL

Olaratumab given IV on Day 1 and Day 8 (21 day cycle) concurrently with radiotherapy. Radiotherapy addendum was not implemented.

Drug: OlaratumabRadiation: External Beam Radiotherapy

Interventions

OlaratumabDRUG

Administered IV

Also known as: LY3012207
Olaratumab + DoxorubicinOlaratumab + Radiotherapy Addendum
DoxorubicinDRUG

Administered IV

Olaratumab + Doxorubicin
External Beam RadiotherapyRADIATION
Olaratumab + Radiotherapy Addendum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

USC/Norris Comp Cancer Center

Los Angeles, California, 90033, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Moffitt Cancer Center & Research Inst

Tampa, Florida, 33612, United States

Location

Kansas City Cancer Center

Overland Park, Kansas, 66210, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

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, 69373, France

Location

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.

Milan, 20133, Italy

Location

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, 08025, Spain

Location

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.

Seville, 41013, Spain

Location

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, SW3 6JJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Sarcoma

Interventions

olaratumabDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Limitations and Caveats

Radiotherapy addendum was not implemented due to business decisions. There were no safety or efficacy issues related to the addendum that contributed to this decision.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
Clinicaltrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

May 26, 2016

Study Start

October 11, 2016

Primary Completion

July 5, 2018

Study Completion

July 5, 2018

Last Updated

August 12, 2019

Results First Posted

August 12, 2019

Record last verified: 2019-02

Locations

US(9)GB(1)IT(1)FR(1)ES(2)