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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


Phase 2
12 Years
N/A
Not Enrolling
Both
Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET), Rhabdomyosarcoma, Leiomyosarcoma, Adipocytic Sarcoma, Synovial Sarcoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) at 12 weeks

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13925

NCT ID:

NCT00668148

Start Date:

July 2008

Completion Date:

February 2012

Related Keywords:

  • Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET)
  • Rhabdomyosarcoma
  • Leiomyosarcoma
  • Adipocytic Sarcoma
  • Synovial Sarcoma
  • Sarcoma
  • Ewing's sarcoma / peripheral neuroectodermal tumor (PNET);
  • rhabdomyosarcoma;
  • leiomyosarcoma;
  • adipocytic sarcoma
  • synovial sarcoma
  • Leiomyosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Synovial
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

ImClone Investigational SiteDenver, Colorado  80262
ImClone Investigational SiteSt. Charles, Missouri  63301
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteNew Orleans, Louisiana  70121
ImClone Investigational SiteYpsilanti, Michigan  48198
ImClone Investigational SiteCleveland, Ohio  44134