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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00515697 |
The purpose of this study is to determine whether IMC-1121B is effective treatment in patients with metastatic renal cell carcinoma who have developed progressive disease or become intolerant to tyrosine kinase inhibitor therapy.
Condition | Intervention | Phase |
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Metastatic Renal Cell Carcinoma |
Drug: 1121B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Single Arm Study of IMC-1121B in Patients With Metastatic Renal Cell Carcinoma With Disease Progression on or Intolerance to Tyrosine Kinase Inhibitor Therapy |
Estimated Enrollment: | 36 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Injectable solution in single-use, 50 mL vials containing 250 mg (5.0 mg/mL)of product administered as an i.v. infusion at 8 mg/kg every 2 weeks in the absence of disease progression or other withdrawal criteria. Cycles will be 14 days in length. As additional safety, pharmacokinetic and efficacy data are available from phase I studies, the dose and schedule may be modified.
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Drug: 1121B
IMC-1121B injectable solution in single-use, 50 mL vials containing 250 mg (5.0 mg/mL)of product administered as an i.v. infusion at 8 mg/kg every 2 weeks in the absence of disease progression or other withdrawal criteria. Cycles will be 14 days in length. As additional safety, pharmacokinetic and efficacy data are available from phase I studies, the dose and schedule may be modified.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Stephanie Wagner, RN, BSN | 908-541-8279 | stephanie.wagner@imclone.com |
United States, California | |
California Pacific Medical Center | Not yet recruiting |
San Francisco, California, United States, 94115 | |
Contact: David R Minor, MD 415-885-8600 | |
Principal Investigator: David R Minor, MD | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Walter Stadler, MD, FACP 773-702-4150 | |
Contact: Edwin Posadas, MD 773-834-5137 | |
Principal Investigator: Walter Stadler, MD | |
Sub-Investigator: Edwin Posadas | |
United States, Louisiana | |
Jayne Gurtler | Recruiting |
Metairie, Louisiana, United States, 70006 | |
Contact: Jayne Gurtler, MD 504-885-0577 | |
Principal Investigator: Jayne Gurtler, MD | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Toni Choueiri, MD | |
United States, New Jersey | |
Hunterdon Regional Cancer Center | Recruiting |
Flemington, New Jersey, United States, 08822 | |
Contact: Myron Bednar, MD 908-788-6461 | |
Principal Investigator: Myron E Bednar, MD | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Principal Investigator: Michael K Wong, MD | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Jorge Garcia, MD 216-444-7774 | |
Principal Investigator: Jorge. Garcia, MD | |
United States, Pennsylvania | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Contact: Gary Hudes, MD 215-728-4300 | |
Principal Investigator: Gary Hudes, MD | |
Consultants in Medical Oncology and Hematology | Withdrawn |
Drexel Hill, Pennsylvania, United States, 19026 | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Principal Investigator: Weijing Sun, MD | |
United States, Texas | |
Arlington Cancer Center | Recruiting |
Arlington, Texas, United States, 76012 | |
Contact: Anwar Khurshid, MD 817-261-4906 | |
Principal Investigator: Anwar Khurshid, MD | |
United States, Washington | |
Seattle Cancer Center Alliance | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: John Thompson, MD 206-288-1195 | |
Principal Investigator: John A Thompson, MD |
Study Chair: | Jonathan D Schwartz, MD | ImClone Systems |
Responsible Party: | ImClone Systems ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP12-0605 |
Study First Received: | August 13, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00515697 |
Health Authority: | United States: Food and Drug Administration |
Disease Progression Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Disease Attributes Neoplasms Pathologic Processes Neoplasms by Site Neoplasms by Histologic Type |