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| Sponsor: | Medarex |
|---|---|
| Information provided by: | Medarex |
| ClinicalTrials.gov Identifier: | NCT00730639 |
Purpose
The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Castration-resistant Prostrate Cancer (mCRPC) Renal Cell Carcinoma (RCC) Malignant Melanoma (MEL) Non-small Cell Lung Cancer (NSCLC) |
Biological: MDX-1106 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of MDX-1106 in Subjects With Selected Advanced or Recurrent Malignancies |
| Estimated Enrollment: | 76 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Dose Escalating cohort: Experimental
3 cohorts
|
Biological: MDX-1106
MDX-1106 iv infusion, at selected dose every 2 weeks for a total of 4 doses, up to 12 eight (8) week cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| Yale Comprehensive Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Study Coordinator 203-785-2604 | |
| Principal Investigator: Mario Sznol, MD | |
| United States, Maryland | |
| John Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Alice Pons ponsal@jhmi.edu | |
| Principal Investigator: Julie Brahmer, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Study Coordinator 617-726-0605 | |
| Sub-Investigator: Donald P Lawrence, MD | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Study Coordinator 617-582-7116 | |
| Principal Investigator: F. Stephen Hodi, MD | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Study Coordinator 617-632-9293 | |
| Sub-Investigator: David F. McDermott, MD | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center, Ravitz Phase 1 Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Study Coordinator, BSN 734-615-6661 | |
| Principal Investigator: David C. Smith, MD | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Latisha Pace pacel@mskcc.org | |
| Principal Investigator: Richard Carvajal, MD | |
| United States, North Carolina | |
| Carolina BioOncology Institute Cancer Therapy and Research Center | Recruiting |
| Huntersville, North Carolina, United States, 28078 | |
| Contact: Study Coordinator 704-947-6599 | |
| Principal Investigator: John Powderly, MD | |
| United States, Ohio | |
| The Christ Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: Kim Dissanayake kim.dissanayake@thechristhospital.com | |
| Principal Investigator: Philip Leming, MD | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Serena Rucker, RN Serena.rucker@vanderbilt.edu | |
| Principal Investigator: Jeffrey Sosman, MD | |
| Study Director: | Medarex Medical Monitor | Medarex |
More Information
| Responsible Party: | Medarex Inc. ( Medarex Inc. ) |
| Study ID Numbers: | MDX1106-03 |
| Study First Received: | August 4, 2008 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00730639 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Neuroendocrine Tumors Carcinoma Melanoma Neuroectodermal Tumors Neoplasms Neoplasms by Site |
Urologic Diseases Respiratory Tract Diseases Kidney Neoplasms Lung Neoplasms Neoplasms, Germ Cell and Embryonal Lung Diseases Carcinoma, Renal Cell Nevi and Melanomas Kidney Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |