A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
NCT ID: NCT00668148
Last Updated: 2018-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2008-07-31
2012-02-29
Brief Summary
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1. Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
2. rhabdomyosarcoma
3. leiomyosarcoma
4. adipocytic sarcoma
5. synovial sarcoma.
A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IMC-A12 (cixutumumab)
IMC-A12 (cixutumumab)
Ewing's Sarcoma/PNET
10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Rhabdomyosarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Leiomyosarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Adipocytic sarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Synovial sarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
Interventions
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IMC-A12 (cixutumumab)
Ewing's Sarcoma/PNET
10 milligrams per kilogram (mg/kg) intravenous (IV) infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Rhabdomyosarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Leiomyosarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Adipocytic sarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
IMC-A12 (cixutumumab)
Synovial sarcoma
10 mg/kg IV infusion every two weeks.
A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has measurable disease, at least one lesion ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
* Has at least one measurable lesion located outside of a previously irradiated area
* Has radiographic documentation of disease progression within 6 months prior to study entry
* Has relapsed, refractory, and/or metastatic disease, incurable by surgery, radiotherapy, or other conventional systemic therapy
* Been considered ineligible for systemic chemotherapy or received at least one previous regimen for relapsed, refractory, and/or metastatic disease
* Adequate hematologic function
* Has adequate hepatic function
* Has adequate coagulation function
* Has adequate renal function
* Has fasting serum glucose \< 120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
* Women of childbearing potential and men 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:
* Has uncontrolled brain or leptomeningeal metastases
* Not recovered to grade ≤ 1 from adverse events due to agents administered more than 3 weeks prior to study entry
* Is receiving any other investigational agent(s)
* Major surgery, hormonal therapy (other than replacement), chemotherapy, radiotherapy, or any form of investigational therapy within 3 weeks prior to enrollment
* History of treatment with other agents targeting the insulin-like growth factor-I receptor (IGF-IR)
* History of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-A12
* Has poorly controlled diabetes mellitus
* Is receiving therapy with immunosuppressive agents
* Is pregnant or breastfeeding
12 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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E-mail: ClinicalTrials@ ImClone.com
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Aurora, Colorado, United States
ImClone Investigational Site
Orlando, Florida, United States
ImClone Investigational Site
Metairie, Louisiana, United States
ImClone Investigational Site
Metairie, Louisiana, United States
ImClone Investigational Site
Detroit, Michigan, United States
ImClone Investigational Site
St Louis, Missouri, United States
ImClone Investigational Site
Columbus, Ohio, United States
ImClone Investigational Site
Brussels, , Belgium
ImClone Investigational Site
Leuven, , Belgium
ImClone Investigational Site
Wilrijk, , Belgium
ImClone Investigational Site
Bordeaux, , France
ImClone Investigational Site
Lyon, , France
ImClone Investigational Site
Paris, , France
ImClone Investigational Site
Toulouse, , France
ImClone Investigational Site
Dresden, , Germany
ImClone Investigational Site
Mannheim, , Germany
ImClone Investigational Site
Leiden, , Netherlands
ImClone Investigational Site
Warsaw, , Poland
ImClone Investigational Site
Barcelona, , Spain
ImClone Investigational Site
Barcelona, , Spain
ImClone Investigational Site
Barcelona, , Spain
ImClone Investigational Site
Barcelona, , Spain
Countries
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References
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Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.
Other Identifiers
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2007-006719-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CP13-0707
Identifier Type: OTHER
Identifier Source: secondary_id
I5A-IE-JAEC
Identifier Type: OTHER
Identifier Source: secondary_id
13925
Identifier Type: -
Identifier Source: org_study_id
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