|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | ImClone LLC |
|---|---|
| Information provided by: | ImClone LLC |
| 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 |
| 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: | August 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
IMC-A12: 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. |
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 patients 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 |
Inclusion:
Exclusion
Contacts and Locations| Contact: Paul Windt | 908-541-8151 | paul.windt@imclone.com |
| United States, Colorado | |
| University of Colorado Health Sciences Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Tiffany Colvin 720-848-0664 tiffany.colvin@uchsc.edu | |
| Principal Investigator: Anthony Elias, MD | |
| The Children's Hospital | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Deb Schissel DSchissel@tchden.org | |
| Principal Investigator: Lia Gore, MD | |
| United States, Florida | |
| MD Anderson Cancer Center Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Meg Caldwell 321-841-6653 meghan.cadwell@orlandohealth.com | |
| Principal Investigator: Gregory K Pennock, MD | |
| United States, Louisiana | |
| Jayne Gurtler MD | Recruiting |
| Metairie, Louisiana, United States, 70006-2921 | |
| Contact: Jeannette Vicknair 504-885-0577 jvicknair@metaireoncologists.org | |
| Principal Investigator: Jayne Gurtler, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201-2014 | |
| Contact: Radika Yalamanchili 313-576-9364 | |
| Principal Investigator: Shirish Gadgeel, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Kristina Williams 314-362-6963 kjwillia1@im.wustl.edu | |
| Principal Investigator: Douglas Adkins, MD | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Dina Aziz 614-293-7961 | |
| Principal Investigator: Anterpreet Neki, MD | |
| Belgium | |
| Institute Jules Bordet | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Adeline Boissy 32 541 7245 adeline.boissy@bordet.be | |
| Principal Investigator: Thierry Gil, Dr | |
| U.Z. Gasthuisberg, Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Inge Le Beer 32 1634 1020 inge.le.beer@uz.kuleuven.ac.be | |
| Principal Investigator: Patrick Schoffski, Dr | |
| AS St. Augustinus | Recruiting |
| Wilrijk, Belgium, 2610 | |
| Contact: Hilde Maes 32 443 3759 hilde.maes@gza.be | |
| Principal Investigator: Luc Yves Dirix, Dr | |
| France | |
| Centre Leon Berard | Recruiting |
| Lyon, France, 69008 | |
| Contact: Jean-Yves Blay, Prof. 33-4797-927-57 blay@lyon.fnclcc.fr | |
| Principal Investigator: Jean-Yves Blay, Prof. | |
| Netherlands | |
| Leids Universitair Medisch Centrum | Recruiting |
| Leiden, Netherlands, 2333 | |
| Contact: Inge Roozen 31-71-526-1987 | |
| Principal Investigator: Hans Gelderblom, Dr | |
| Poland | |
| Centrum Onkologii Instytut im Marii Sklodowskiej-Curie | Recruiting |
| Warsaw, Poland | |
| Contact: Piotr Rutkowski, Dr 48-501-153-384 | |
| Principal Investigator: Wlodzimierz Ruka, Prof | |
| Spain | |
| Hospital Vall d'Hebron | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Mireia Centelles 34-93-489-4375 | |
| Principal Investigator: Maria V Morales, Dr | |
| Institut Català d'Oncologia (ICO)-L'Hospitalet | Recruiting |
| Barcelona, Spain, 08907 | |
| Contact: Pepi Rivera 34-93-260-7332 | |
| Principal Investigator: Xavier G del Muro, Dr | |
| Hospital De Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Rosa Sánchez 34-93-553-7116 | |
| Principal Investigator: Antonio Lopez-Pousa, Dr | |
| Study Director: | Eric Rowinsky, MD | ImClone LLC |
More Information
| Responsible Party: | ImClone LLC ( Eric Rowinsky/ Chief Medical Officer ) |
| Study ID Numbers: | CP13-0707, EudraCT Number: 2007-006719-21 |
| Study First Received: | April 25, 2008 |
| Last Updated: | November 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00668148 History of Changes |
| 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: Agencia Espanola de Medicamentos y Productos Sanitarios; Germany: PAUL-EHRLICH-INSTITUT (BUNDESAMT FUER SERA UND IMPFSTOFFE); Belgium: Madame Greet Musch, Responsable departement R&D; France: Agence Francaise de Securite des Produits de Sante (AFSSAPS) |
|
Sarcoma Ewing's sarcoma / peripheral neuroectodermal tumor (PNET); rhabdomyosarcoma; |
leiomyosarcoma; adipocytic sarcoma synovial sarcoma |
|
Neoplasms, Muscle Tissue Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Leiomyosarcoma Myosarcoma Neoplasms, Nerve Tissue Osteosarcoma Sarcoma, Synovial Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue |
Sarcoma, Ewing's Neoplasms Neoplasms, Bone Tissue Neoplasms, Germ Cell and Embryonal Sarcoma Neoplasms, Connective Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial Rhabdomyosarcoma |