Trials / Completed
CompletedNCT00668148
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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. A total of 85 participants 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 at every cycle. Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.
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.
Conditions
- Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET)
- Rhabdomyosarcoma
- Leiomyosarcoma
- Adipocytic Sarcoma
- Synovial Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IMC-A12 (cixutumumab) | 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. |
| BIOLOGICAL | IMC-A12 (cixutumumab) | Rhabdomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
| BIOLOGICAL | IMC-A12 (cixutumumab) | Leiomyosarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
| BIOLOGICAL | IMC-A12 (cixutumumab) | Adipocytic sarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
| BIOLOGICAL | IMC-A12 (cixutumumab) | Synovial sarcoma 10 mg/kg IV infusion every two weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle. |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2010-10-01
- Completion
- 2012-02-01
- First posted
- 2008-04-29
- Last updated
- 2018-07-17
- Results posted
- 2018-07-17
Locations
22 sites across 7 countries: United States, Belgium, France, Germany, Netherlands, Poland, Spain
Source: ClinicalTrials.gov record NCT00668148. Inclusion in this directory is not an endorsement.