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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Collaborator: |
Ono Pharmaceutical Company, Ltd. |
| Information provided by (Responsible Party): | Bristol-Myers Squibb |
| 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) Metastatic Melanoma (MEL) Non-small Cell Lung Cancer (NSCLC) |
Biological: BMS-936558 (MDX-1106) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 290 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Melanoma - BMS-936558 (MDX-1106) |
Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
|
| Experimental: RCC - BMS-936558 (MDX-1106) |
Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
|
| Experimental: mCRPC - BMS-936558 (MDX-1106) |
Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
|
| Experimental: NSCLC - BMS-936558 (MDX-1106) |
Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
|
| Experimental: CRC - BMS-936558 (MDX-1106) |
Biological: BMS-936558 (MDX-1106)
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Other Name: BMS-936558
|
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: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00730639 History of Changes |
| Other Study ID Numbers: | MDX1106-03, CA209-003 |
| Study First Received: | August 4, 2008 |
| Last Updated: | October 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Lung Neoplasms Melanoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas |