Overview

This trial is active, not recruiting.

Condition sarcoma, soft tissue
Treatments olaratumab, doxorubicin
Phase phase 1
Target PDGF
Sponsor Eli Lilly and Company
Start date January 2015
End date May 2015
Trial size 48 participants
Trial identifier NCT02326025, 15676, I5B-EW-JGDI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Olaratumab administered intravenously (IV) on Day 10 of Cycle 1 and Days 1 and 8 of Cycles 2 through 8. Participants may continue to receive olaratumab after Cycle 8, until discontinuation criteria are met.
olaratumab LY3012207
Administered IV
(Experimental)
On Cycle 1, Day 1 doxorubicin will be administered via IV infusion. On Cycle 1, Day 10, olaratumab administered via IV infusion. For Cycles 2 to 8, olaratumab administered on Days 1 and 8 of each 21-day cycle, via IV infusion. On Day 1 of Cycles 2 to 8, doxorubicin will be administered via IV infusion immediately following the completion of the olaratumab infusion.
olaratumab LY3012207
Administered IV
doxorubicin
Administered IV
(Experimental)
Olaratumab administered intravenously (IV) on Day 10 of Cycle 1 and Days 1 and 8 of Cycles 2 through 8. Participants may continue to receive olaratumab after Cycle 8, until discontinuation criteria are met.
olaratumab LY3012207
Administered IV
(Experimental)
On Cycle 1, Day 1 doxorubicin will be administered via IV infusion. On Cycle 1, Day 10, olaratumab administered via IV infusion. For Cycles 2 to 8, olaratumab administered on Days 1 and 8 of each 21-day cycle, via IV infusion. On Day 1 of Cycles 2 to 8, doxorubicin will be administered via IV infusion immediately following the completion of the olaratumab infusion.
olaratumab LY3012207
Administered IV
doxorubicin
Administered IV

Primary Outcomes

Measure
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
Pharmacokinetics: Maximum Concentration (Cmax)
time frame: Baseline through 10 days after doxorubicin administration in Cycle 1 and through Day 8 of Cycle 2

Secondary Outcomes

Measure
Pharmacokinetics: Area Under The Concentration Curve (AUC)
time frame: Post olaratumab dose on Day 10 of Cycle 1 through Day 1 of Cycle 2
Pharmacokinetics: Maximum Concentration (Cmax)
time frame: Post olaratumab dose in Day 10 of Cycle 1 and through Day 1 of Cycle 2

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Part A participants only: Have current hematologic malignancies, acute or chronic leukemia - 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.