A Study of Olaratumab in Soft Tissue Sarcoma

NCT ID: NCT01185964

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-04-30

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.

Conditions

Sarcoma, Soft Tissue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b: Olaratumab + doxorubicin

All cycles are 21 days.

Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1

All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: BIOLOGICAL

Olaratumab 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle

doxorubicin

Intervention Type: DRUG

Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.

Phase 2: Olaratumab and doxorubicin

All cycles are 21 days.

Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1

All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: BIOLOGICAL

Olaratumab 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle

doxorubicin

Intervention Type: DRUG

Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.

Phase 2: Doxorubicin: Optional Olaratumab After Progression

All cycles are 21 days.

Cycles 1-8: doxorubicin 75 mg/m2 on day 1 until disease progression.

At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.

Group Type: ACTIVE_COMPARATOR

doxorubicin

Intervention Type: DRUG

Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.

Interventions

Olaratumab

Olaratumab 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle

Intervention Type: BIOLOGICAL

doxorubicin

Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.

Intervention Type: DRUG

Other Intervention Names

LY3012207; IMC-3G3

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Tucson, Arizona, United States

ImClone Investigational Site

Los Angeles, California, United States

ImClone Investigational Site

Aurora, Colorado, United States

ImClone Investigational Site

Gainesville, Florida, United States

ImClone Investigational Site

Orlando, Florida, United States

ImClone Investigational Site

Atlanta, Georgia, United States

ImClone Investigational Site

Chicago, Illinois, United States

ImClone Investigational Site

Rochester, Minnesota, United States

ImClone Investigational Site

St Louis, Missouri, United States

ImClone Investigational Site

New York, New York, United States

ImClone Investigational Site

Charlotte, North Carolina, United States

ImClone Investigational Site

Cleveland, Ohio, United States

ImClone Investigational Site

Charleston, South Carolina, United States

ImClone Investigational Site

Memphis, Tennessee, United States

ImClone Investigational Site

San Antonio, Texas, United States

ImClone Investigational Site

Seattle, Washington, United States

ImClone Investigational Site

Madison, Wisconsin, United States

Countries

United States

References

Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. doi: 10.1016/S0140-6736(16)30587-6. Epub 2016 Jun 9.

Reference Type: DERIVED

PMID: 27291997 (View on PubMed)

Other Identifiers

I5B-IE-JGDG

Identifier Type: OTHER

Identifier Source: secondary_id

CP15-0806

Identifier Type: OTHER

Identifier Source: secondary_id

14055

Identifier Type: -

Identifier Source: org_study_id