A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma
A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET
4 other identifiers
interventional
113
7 countries
22
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 will be stratified into five tiers according to diagnosis:
- 1.Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
- 2.rhabdomyosarcoma
- 3.leiomyosarcoma
- 4.adipocytic sarcoma
- 5.synovial sarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2008
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
July 17, 2018
CompletedJuly 17, 2018
June 1, 2018
2.3 years
April 25, 2008
March 17, 2018
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks
PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. Percentage of participants is calculated as the total number of participants with PFS at 12 weeks divided by the total number of participants treated then multiplied by 100.
Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks
Secondary Outcomes (8)
Progression-Free Survival (PFS)
Baseline to measured PD (up to 105.4 weeks)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Baseline to measured PD (up to 105.4 weeks)
Time to Response
Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks)
Duration of Response
Date of first response to the date of progression or death due to any cause (up to 105.4 weeks)
Overall Survival (OS)
Baseline to date of death from any cause (up to 112.9 weeks)
- +3 more secondary outcomes
Study Arms (1)
IMC-A12 (cixutumumab)
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
ImClone Investigational Site
Aurora, Colorado, 80045, United States
ImClone Investigational Site
Orlando, Florida, 32806, United States
ImClone Investigational Site
Metairie, Louisiana, 70006-2921, United States
ImClone Investigational Site
Metairie, Louisiana, 70006, United States
ImClone Investigational Site
Detroit, Michigan, 48201-2014, United States
ImClone Investigational Site
St Louis, Missouri, 63110, United States
ImClone Investigational Site
Columbus, Ohio, 43210, United States
ImClone Investigational Site
Brussels, 1000, Belgium
ImClone Investigational Site
Leuven, 3000, Belgium
ImClone Investigational Site
Wilrijk, 2610, Belgium
ImClone Investigational Site
Bordeaux, 33076, France
ImClone Investigational Site
Lyon, 69008, France
ImClone Investigational Site
Paris, 75231, France
ImClone Investigational Site
Toulouse, 31052, France
ImClone Investigational Site
Dresden, 01307, Germany
ImClone Investigational Site
Mannheim, 68167, Germany
ImClone Investigational Site
Leiden, 2333 ZA, Netherlands
ImClone Investigational Site
Warsaw, 02-781, Poland
ImClone Investigational Site
Barcelona, 08025, Spain
ImClone Investigational Site
Barcelona, 08035, Spain
ImClone Investigational Site
Barcelona, 08041, Spain
ImClone Investigational Site
Barcelona, 08907, Spain
Related Publications (1)
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.
PMID: 22682017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
E-mail: ClinicalTrials@ ImClone.com
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2008
First Posted
April 29, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2010
Study Completion
February 1, 2012
Last Updated
July 17, 2018
Results First Posted
July 17, 2018
Record last verified: 2018-06