Status:
COMPLETED
A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET)
Rhabdomyosarcoma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants w...
Detailed Description
The purpose of this study is to determine the progression-free survival (PFS) rate assessed 12 weeks after the initiation of IMC-A12 monotherapy, administered every 2 weeks to participants with previo...
Eligibility Criteria
Inclusion
- Inclusion:
- Histologically or cytologically-confirmed sarcoma of one of the following histologies: (1) Ewing's sarcoma / PNET; (2) rhabdomyosarcoma; (3) leiomyosarcoma; (4) adipocytic sarcoma; or (5) synovial sarcoma
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00668148
Start Date
July 1 2008
End Date
February 1 2012
Last Update
July 17 2018
Active Locations (22)
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1
ImClone Investigational Site
Aurora, Colorado, United States, 80045
2
ImClone Investigational Site
Orlando, Florida, United States, 32806
3
ImClone Investigational Site
Metairie, Louisiana, United States, 70006-2921
4
ImClone Investigational Site
Metairie, Louisiana, United States, 70006