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| Sponsored by: |
ImClone Systems |
| Information provided by: | ImClone Systems |
| ClinicalTrials.gov Identifier: | NCT00668148 |
Purpose
This multicenter, open-label, phase 2 study will enroll approximately 185 patients with metastatic or advanced sarcoma, to assess the efficacy and tolerability of IMC-A12 monotherapy for this indication. The patient population will be stratified into five tiers according to diagnosis:
A total of 85 patients will be enrolled initially, 17 in each tier. Patients will receive single agent IMC-A12 as a 10 mg/kg intravenous (I.V.) infusion over 1 hour every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation every cycle.
The Simon two-stage design will be applied separately to each tier; 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 (for a total of 185 subjects)
| Condition | Intervention | Phase |
|
Ewing's Sarcoma /Peripheral Neuroectodermal Tumor (PNET) Rhabdomyosarcoma Leiomyosarcoma Adipocytic Sarcoma Synovial Sarcoma |
Biological: IMC-A12 |
Phase II |
| MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
| ChemIDplus related topics: | Sodium chloride Citric acid Sodium Citrate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 185 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
IMC-A12 injection for intravenous use, supplied in single-use 90 mg/20-mL or 250 mg/50-mL vials containing 4.5 mg/mL in phosphate-buffered saline or 5 mg/mL in citrate-based saline, respectively, and administered intravenously at a dose of 10 mg/kg every 2 weeks.
|
Biological: IMC-A12
IMC-A12 injection for intravenous use, supplied in single-use 90 mg/20-mL or 250 mg/50-mL vials containing 4.5 mg/mL in phosphate-buffered saline or 5 mg/mL in citrate-based saline, respectively, and administered intravenously at a dose of 10 mg/kg every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation every cycle. There will be no interruption between treatment cycles. Patients will be treated until there is evidence of disease progression, toxicity requiring cessation, or withdrawal of consent. |
Eligibility
| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion
Contacts and Locations| Contact: Paul Windt | 908-541-8151 | paul.windt@imclone.com |
| United States, Florida | |||||
| MD Anderson Cancer Center Orlando | Recruiting | ||||
| Orlando, Florida, United States, 32806 | |||||
| Contact: Meg Caldwell 321-841-6653 | |||||
| Principal Investigator: Gregory K Pennock, MD | |||||
| United States, Michigan | |||||
| Wayne State Univcrsiiy | Recruiting | ||||
| Detroit, Michigan, United States, 48201-2014 | |||||
| Principal Investigator: Shirish Gadgeel, MD | |||||
| ImClone Systems |
More Information
| Responsible Party: | ImClone ( Polina Binder, MD ) |
| Study ID Numbers: | CP13-0707 |
| First Received: | April 25, 2008 |
| Last Updated: | August 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00668148 |
| Health Authority: | United States: Food and Drug Administration |
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