A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00668148
First received: April 25, 2008
Last updated: May 8, 2012
Last verified: September 2011
  Purpose

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/PNET
  2. rhabdomyosarcoma
  3. leiomyosarcoma
  4. adipocytic sarcoma
  5. synovial sarcoma.

A total of 85 patients 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 every cycle.

Safety and response in the initial 17 patients in each tier will be used to determine whether to extend enrollment to the target total of 37 patients per tier.


Condition Intervention Phase
Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET)
Rhabdomyosarcoma
Leiomyosarcoma
Adipocytic Sarcoma
Synovial Sarcoma
Biological: IMC-A12 (cixutumumab)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Progression-free survival (PFS) at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall PFS rate [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
    Overall PFS rate is the interval from the date of first treatment until date of progressive (PD) or death due to any cause.

  • Objective response rate (ORR) [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
    Objective response rate (ORR)is the interval from the date of first treatment until date of progressive (PD) or recurrence.

  • Time to response [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
    Time to response is from the date of first treatment to the first occurance of either a complete response (CR) or partial response (PR).

  • Duration of response [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
    Duration of response is measured from the time of the first occurrence of either a complete response (CR) or partial response (PR) to the first date of progressive disease or death.

  • Overall survival (OS) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as the interval between date of enrollment and the date of death from any cause.

  • Clinical benefit rate (CBR) [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
    Clinical benefit rate (CBR) is defined as the percentage of participants whose best overall response is either CR, PR, or stable disease (SD).

  • Number of Participants with Adverse events (AEs) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: Yes ]
  • Serum Anti-IMC-A12 Antibody assessment (immunogenicity) [ Time Frame: Approximately 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: July 2008
Study Completion Date: February 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-A12 (cixutumumab) Biological: IMC-A12 (cixutumumab)

Ewing's Sarcoma/peripheral neuroectodermal tumor (PNET)

10 mg/kg intravenous (I.V.) infusion every two weeks.

A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Other Name: cixutumumab
Biological: IMC-A12 (cixutumumab)

Rhabdomyosarcoma

10 mg/kg intravenous (I.V.) infusion every two weeks.

A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Other Name: cixutumumab
Biological: IMC-A12 (cixutumumab)

Leiomyosarcoma

10 mg/kg intravenous (I.V.) infusion every two weeks.

A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Other Name: cixutumumab
Biological: IMC-A12 (cixutumumab)

Adipocytic sarcoma

10 mg/kg intravenous (I.V.) infusion every two weeks.

A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Other Name: cixutumumab
Biological: IMC-A12 (cixutumumab)

Synovial sarcoma

10 mg/kg intravenous (I.V.) infusion every two weeks.

A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.

Other Name: cixutumumab

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 previously-treated, advanced or metastatic soft tissue and Ewing's sarcoma/PNET.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 mg/dL or below the 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 IGFR
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668148

Locations
United States, Colorado
ImClone Investigational Site
Aurora, Colorado, United States, 80045
United States, Florida
ImClone Investigational Site
Orlando, Florida, United States, 32806
United States, Louisiana
ImClone Investigational Site
Metairie, Louisiana, United States, 70006-2921
ImClone Investigational Site
Metairie, Louisiana, United States, 70006
United States, Michigan
ImClone Investigational Site
Detroit, Michigan, United States, 48201-2014
United States, Missouri
ImClone Investigational Site
St Louis, Missouri, United States, 63110
United States, Ohio
ImClone Investigational Site
Columbus, Ohio, United States, 43210
Belgium
ImClone Investigational Site
Brussels, Belgium, 1000
ImClone Investigational Site
Leuven, Belgium, 3000
ImClone Investigational Site
Wilrijk, Belgium, 2610
France
ImClone Investigational Site
Bordeaux, France, 33076
ImClone Investigational Site
Lyon, France, 69008
ImClone Investigational Site
Paris, France, 75231
ImClone Investigational Site
Toulouse, France, 31052
Germany
ImClone Investigational Site
Dresden, Germany, 01307
ImClone Investigational Site
Mannheim, Germany, 68167
Netherlands
ImClone Investigational Site
Leiden, Netherlands, 2333 ZA
Poland
ImClone Investigational Site
Warsaw, Poland, 02-781
Spain
ImClone Investigational Site
Barcelona, Spain, 08035
ImClone Investigational Site
Barcelona, Spain, 08907
ImClone Investigational Site
Barcelona, Spain, 08025
ImClone Investigational Site
Barcelona, Spain, 08041
Sponsors and Collaborators
ImClone LLC
Investigators
Study Director: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

No publications provided by ImClone LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ImClone LLC
ClinicalTrials.gov Identifier: NCT00668148     History of Changes
Other Study ID Numbers: 13925, 2007-006719-21, CP13-0707, I5A-IE-JAEC
Study First Received: April 25, 2008
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Germany: Paul-Ehrlich-Institut
Belgium: Madame Greet Musch, Responsible departement R&D
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ImClone LLC:
Sarcoma
Ewing's sarcoma / peripheral neuroectodermal tumor (PNET);
rhabdomyosarcoma;
leiomyosarcoma;
adipocytic sarcoma
synovial sarcoma

Additional relevant MeSH terms:
Sarcoma, Ewing
Sarcoma
Rhabdomyosarcoma
Neuroectodermal Tumors
Leiomyosarcoma
Sarcoma, Synovial
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 22, 2014