Trial record 1 of 1 for:    NCT01185964
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A Study of IMC-3G3 in Soft Tissue Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01185964
First received: August 19, 2010
Last updated: March 10, 2014
Last verified: March 2014
  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 Intervention Phase
Sarcoma, Soft Tissue
Biological: IMC-3G3
Drug: doxorubicin
Drug: dexrazoxane
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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 ]

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.


Enrollment: 146
Study Start Date: October 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Biological: IMC-3G3
IMC-3G3 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle
Other Name: LY3012207
Drug: 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.
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

Biological: IMC-3G3
IMC-3G3 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle
Other Name: LY3012207
Drug: 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.
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

Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185964

Locations
United States, Arizona
ImClone Investigational Site
Tucson, Arizona, United States, 85724
United States, California
ImClone Investigational Site
Los Angeles, California, United States, 90024
United States, Colorado
ImClone Investigational Site
Aurora, Colorado, United States, 80045
United States, Florida
ImClone Investigational Site
Gainesville, Florida, United States, 32608
ImClone Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
ImClone Investigational Site
Atlanta, Georgia, United States, 30308
United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60611
United States, Minnesota
ImClone Investigational Site
Rochester, Minnesota, United States, 55902
United States, Missouri
ImClone Investigational Site
St Louis, Missouri, United States, 63110
United States, New York
ImClone Investigational Site
New York, New York, United States, 10065
United States, North Carolina
ImClone Investigational Site
Charlotte, North Carolina, United States, 28203
United States, Ohio
ImClone Investigational Site
Cleveland, Ohio, United States, 44106
United States, South Carolina
ImClone Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
ImClone Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
ImClone Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
ImClone Investigational Site
Seattle, Washington, United States, 98109
United States, Wisconsin
ImClone Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01185964     History of Changes
Other Study ID Numbers: 14055, I5B-IE-JGDG, CP15-0806
Study First Received: August 19, 2010
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Sarcoma, Soft Tissue
Advanced Soft Tissue Sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Razoxane
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014