A Phase 1b Study of Olaratumab, Doxorubicin and Ifosfamide in the Treatment of Patients With Advanced or Metastatic Soft Tissue Sarcoma

Status: Completed
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Have a histological diagnosis of advanced STS (by local pathology review), for which treatment with doxorubicin, ifosfamide and mesna is deemed appropriate by the investigator.

• Have measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

• Have adequate hematologic, organ and coagulation function within 2 weeks (14 days) prior to enrollment.

• Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale.

• Have received no prior lines of systemic therapy and are suitable to receive doxorubicin, ifosfamide and mesna. All previous anticancer treatments must have completed ≥3 weeks (21 days) prior to the first dose of study treatment.

• Have left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to enrollment.

• Have resolution of Adverse Events (AEs), with the exception of alopecia, and of all clinically significant toxic effects of prior locoregional therapy, surgery or radiotherapy to ≤Grade 1, by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.

• Have sufficient available material from archived formalin-fixed paraffin-embedded tumor tissue for biomarker-related studies. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.

• If male, must be sterile or agree to use an effective method of contraception or a highly effective method of contraception during the study and for at least 12 weeks following the last dose of study treatment.

• If female and of child-bearing potential, must:

• have a negative serum pregnancy test at the time of enrollment,

• have a negative urine pregnancy test within 24 hours prior to the first dose of study treatment, and

• agree to use a highly effective method of contraception during the study and for 3 months following the last dose of study treatment.

• Have a life expectancy of at least 3 months, in the opinion of the investigator.

Locations
United States
Florida
University of Miami School of Medicine
Miami
Texas
University of Texas MD Anderson Cancer Center
Houston
Other Locations
Germany
HELIOS Klinikum Berlin-Buch
Berlin
Universitätsklinikum Essen
Essen
Italy
Università degli Studi di Catania - Azienda Policlinico
Catania
Istituto Nazionale dei Tumori
Milano
Time Frame
Start Date: October 18, 2017
Completion Date: August 25, 2019
Participants
Target number of participants: 24
Treatments
Experimental: Olaratumab + Doxorubicin + Ifosfamide + Mesna
Olaratumab 15 milligrams per kilogram (mg/kg) on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin and ifosfamide was administered. When the safety of the 15-mg/kg dose of olaratumab was established, a 20-mg/kg loading dose cycle of olaratumab on Days 1 and 8 of a 21-day cycle in Cycle 1 only, followed by 15 mg/kg on Days 1 and 8 of subsequent cycles in combination with doxorubicin and ifosfamide plus mesna, was administered.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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