A Study of IMC-3G3 in Soft Tissue Sarcoma
Overview[ - collapse ][ - ]
Purpose | The main purpose of this study is to gather information about the use of an investigational drug called IMC-3G3 with a drug for soft tissue sarcoma called doxorubicin. |
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Condition | Sarcoma, Soft Tissue |
Intervention | Biological: IMC-3G3 Drug: doxorubicin Drug: dexrazoxane |
Phase | Phase 1/Phase 2 |
Sponsor | Eli Lilly and Company |
Responsible Party | Eli Lilly and Company |
ClinicalTrials.gov Identifier | NCT01185964 |
First Received | August 19, 2010 |
Last Updated | March 10, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | August 19, 2010 |
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Last Updated Date | March 10, 2014 |
Start Date | October 2010 |
Estimated Primary Completion Date | January 2015 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study of IMC-3G3 in Soft Tissue Sarcoma |
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Official Title | A Phase 1b/2 Randomized Phase 2 Study Evaluating the Efficacy of Doxorubicin With or Without a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in the Treatment of Advanced Soft Tissue Sarcoma |
Brief Summary | The main purpose of this study is to gather information about the use of an investigational drug called IMC-3G3 with a drug for soft tissue sarcoma called doxorubicin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1/Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Sarcoma, Soft Tissue |
Intervention | Biological: IMC-3G3 IMC-3G3 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle Other Names: LY3012207Drug: doxorubicin Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle. Drug: dexrazoxane Dexrazoxane given at 750 mg/m2 by intravenous injection on day 1 of the 21-day cycle prior to administration of each doxorubicin infusion during cycles 5-8 for prevention of cardiotoxicity. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 146 |
Estimated Completion Date | January 2015 |
Estimated Primary Completion Date | March 2014 |
Eligibility Criteria | Inclusion Criteria: - The patient has histologically- or cytologically-confirmed malignant soft tissue sarcoma (STS), including uterine leiomyosarcoma - The patient has advanced STS, not amenable to treatment with surgery or radiotherapy - The patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 - The patient has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRα expression - The patient 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 patient 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 patient has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the patient's creatinine clearance is ≥ 45 mL/min - The patient has urinary protein ≤ 1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1 g of protein in 24 hours to allow participation - Because the teratogenicity of IMC-3G3 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 patient has histologically- or cytologically-confirmed Kaposi's sarcoma - The patient has untreated central nervous system metastases - The patient received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone) - The patient received prior radiation therapy to the mediastinal/pericardial area - The patient 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 patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent - The patient has an elective or a planned major surgery to be performed during the course of the study - The patient 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 patient has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry - The patient has known immunodeficiency virus (HIV) infection - The patient, if female, is pregnant or lactating - The patient has a known allergy to any of the treatment components |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01185964 |
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Other Study ID Numbers | 14055 |
Has Data Monitoring Committee | No |
Information Provided By | Eli Lilly and Company |
Study Sponsor | Eli Lilly and Company |
Collaborators | Not Provided |
Investigators | 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 |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
ImClone Investigational Site | Tucson, Arizona, United States, 85724 |
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ImClone Investigational Site | Los Angeles, California, United States, 90024 |
ImClone Investigational Site | Aurora, Colorado, United States, 80045 |
ImClone Investigational Site | Gainesville, Florida, United States, 32608 |
ImClone Investigational Site | Orlando, Florida, United States, 32806 |
ImClone Investigational Site | Atlanta, Georgia, United States, 30308 |
ImClone Investigational Site | Chicago, Illinois, United States, 60611 |
ImClone Investigational Site | Rochester, Minnesota, United States, 55902 |
ImClone Investigational Site | St Louis, Missouri, United States, 63110 |
ImClone Investigational Site | New York, New York, United States, 10065 |
ImClone Investigational Site | Charlotte, North Carolina, United States, 28203 |
ImClone Investigational Site | Cleveland, Ohio, United States, 44106 |
ImClone Investigational Site | Charleston, South Carolina, United States, 29425 |
ImClone Investigational Site | Memphis, Tennessee, United States, 38119 |
ImClone Investigational Site | San Antonio, Texas, United States, 78229 |
ImClone Investigational Site | Seattle, Washington, United States, 98109 |
ImClone Investigational Site | Madison, Wisconsin, United States, 53792 |