Status:
COMPLETED
A Study of Olaratumab in Soft Tissue Sarcoma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study is to gather information about the use of an investigational drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin.
Eligibility Criteria
Inclusion
- The participant has histologically- or cytologically-confirmed malignant soft tissue sarcoma
- The participant has advanced soft tissue sarcoma (STS), not amenable to treatment with surgery or radiotherapy
- The participant's Eastern Cooperative Oncology Group (ECOG) performance status is 0-2
- The participant has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRα expression
- The participant has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500 μL, hemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained within 2 weeks prior to study entry
- The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN)
- The participant has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the participant's creatinine clearance is ≥ 45 mL/min
- Because the teratogenicity of Olaratumab is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion
- The participant has histologically- or cytologically-confirmed Kaposi's sarcoma
- The participant has untreated central nervous system metastases
- The participant received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone)
- The participant received prior radiation therapy to the mediastinal/pericardial area
- The participant has a history of another primary cancer, with the exception of a) curatively resected nonmelanomatous 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
- The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
- The participant has an elective or a planned major surgery to be performed during the course of the study
- The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry
- The participant has known immunodeficiency virus (HIV) infection
- The participant, if female, is pregnant or lactating
- The participant has a known allergy to any of the treatment components
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01185964
Start Date
October 1 2010
End Date
April 1 2016
Last Update
April 14 2017
Active Locations (17)
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1
ImClone Investigational Site
Tucson, Arizona, United States, 85724
2
ImClone Investigational Site
Los Angeles, California, United States, 90024
3
ImClone Investigational Site
Aurora, Colorado, United States, 80045
4
ImClone Investigational Site
Gainesville, Florida, United States, 32608