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

Sponsor:	ImClone LLC
Information provided by (Responsible Party):	ImClone LLC
ClinicalTrials.gov Identifier:	NCT00668148

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:

Ewing's sarcoma/PNET
rhabdomyosarcoma
leiomyosarcoma
adipocytic sarcoma
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 II

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:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

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
Estimated 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

Arms

Assigned Interventions

Experimental: IMC-A12 (cixutumumab)