A Study of IMC-3G3 in Soft Tissue Sarcoma | RxWiki

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.
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
Last Updated Date	March 10, 2014
Start Date	October 2010
Estimated Primary Completion Date	January 2015
Current Primary Outcome Measures	Progression-free survival (PFS) [Time Frame: 23 months] [Designated as safety issue: No]PFS is the primary outcome for the Phase 2 portion of the study. PFS is measured from the date of randomization until the first radiographic documentation of objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause. Summary of Safety for the Phase 1b Portion of the Study [Time Frame: up to 24 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Overall Survival (OS) [Time Frame: 23 months] [Designated as safety issue: No]Date of randomization to the date of death from any cause Percentage of Participants with Objective Response (Objective Response Rate) [Time Frame: 23 months] [Designated as safety issue: No]Percentage of participants achieving a best overall response of partial or complete response (PR + CR), according to RECIST from the start of treatment until disease progression or occurrence. Pharmacokinetic (PK) Profile of IMC-3G3 [Time Frame: up to week 24] [Designated as safety issue: No] Proportion of Participants Who are Progression-free (PFS) at 3 Months [Time Frame: 3 months] [Designated as safety issue: No]The 3 month progression-free survival (PFS) rate is defined as the proportion of participants that are alive and progression-free 3 months after randomization. PFS is measured from the date of randomization until the first radiographic documentation of objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause.

Descriptive Information[ + expand ][ + ]

Brief Title	A Study of IMC-3G3 in Soft Tissue Sarcoma
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)	Experimental: Phase 1b: IMC-3G3 + doxorubicin All cycles are 21 days. Cycles 1-4: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 Cycles 5-8: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 and dexrazoxane 750 mg/m2 on day 1 All subsequent cycles: IMC-3G3 15 mg/kg on days 1+8 Experimental: Phase 2: IMC-3G3 and doxorubicin All cycles are 21 days. Cycles 1-4: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 Cycles 5-8: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 and dexrazoxane 750 mg/m2 on day 1 All subsequent cycles: IMC-3G3 15 mg/kg on days 1+8 Active Comparator: Phase 2: doxorubicin All cycles are 21 days. Cycles 1-4: doxorubicin 75 mg/m2 on day 1 Cycles 5-8: dexrazoxane 750 mg/m2 and doxorubicin 75 mg/m2 on day 1 All subsequent cycles or earlier if disease progresses: IMC-3G3 15 mg/kg on days 1+8

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
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
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
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