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A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02326025
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin.

The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met.

Screening is required within 21 days prior to first dose.

Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin.

Participants may only enroll in one part.


Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Olaratumab Drug: Doxorubicin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin Following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients With Advanced Soft Tissue Sarcoma
Actual Study Start Date : January 22, 2015
Actual Primary Completion Date : May 20, 2015
Actual Study Completion Date : November 2, 2018


Arm Intervention/treatment
Experimental: Olaratumab + Doxorubicin (Part A)

Part A: On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 10, participants received 15 mg/kg of olaratumab IV.

For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants received olaratumab monotherapy after Cycle 8, until discontinuation criteria are met.

Drug: Olaratumab
Administered IV
Other Names:
  • LY3012207
  • IMC-3G3

Drug: Doxorubicin
Administered IV

Experimental: Olaratumab + Doxorubicin (Part B)

Part B: On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

For Cycles 2 to 8, participants received 20 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion. Participants received olaratumab monotherapy after Cycle 8, until discontinuation criteria are met.

Drug: Olaratumab
Administered IV
Other Names:
  • LY3012207
  • IMC-3G3

Drug: Doxorubicin
Administered IV




Primary Outcome Measures :
  1. Pharmacokinetics: Area Under The Concentration Curve (AUC) [ Time Frame: Baseline through 10 days after doxorubicin administration in Cycle 1 and through Day 8 of Cycle 2 (each cycle is 21 days) ]
  2. Pharmacokinetics: Maximum Concentration (Cmax) [ Time Frame: Baseline through 10 days after doxorubicin administration in Cycle 1 and through Day 8 of Cycle 2 (each cycle is 21 days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area Under The Concentration Curve (AUC) [ Time Frame: Post olaratumab dose on Day 10 of Cycle 1 through Day 1 of Cycle 2 (each cycle is 21 days) ]
  2. Pharmacokinetics: Maximum Concentration (Cmax) [ Time Frame: Post olaratumab dose in Day 10 of Cycle 1 and through Day 1 of Cycle 2 (each cycle is 21 days) ]


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 histological or cytological evidence of a diagnosis of soft tissue sarcoma (STS) that is advanced and/or metastatic
  • Have the presence of measurable and/or nonmeasurable disease
  • Have given written informed consent prior to any study-specific procedures
  • Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have discontinued previous treatments for cancer and recovered from the acute effects of therapy
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

  • Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for noncancer indications
  • Have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
  • Have active central nervous system (CNS) metastasis. Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids
  • Have unstable hepatic disease with a grade equal to or greater than Child-Pugh B
  • Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
  • Have a history of another primary cancer, with the exception of a) curatively resected nonmelanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry
  • Have a history of chronic heart failure or left ventricular dysfunction
  • Have a resting heart rate of less than (<)50 beats per minute (bpm) or greater than (>)100 bpm
  • Have a history of radiation therapy involving the mediastinal/pericardial area. Previous radiation therapy is allowed but must not have included whole pelvis radiation

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): NCT02326025


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02326025     History of Changes
Other Study ID Numbers: 15676
I5B-EW-JGDI ( Other Identifier: Eli Lilly and Company )
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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