A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies (MDX1106-01)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00441337
First received: February 27, 2007
Last updated: April 22, 2010
Last verified: April 2010
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Purpose
To determine the safety and tolerability of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, renal clear cell cancer or hormone refractory prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung Colorectal Cancer Malignant Melanoma Renal Cancer Prostate Cancer |
Biological: MDX-1106 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Colorectal Cancer
Kidney Cancer
Lung Cancer
Melanoma
Prostate Cancer
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- incidence and severity of treatment-emergent adverse events [ Time Frame: if they occur, they will be monitored through resolution of the event ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinical laboratory tests [ Time Frame: study duration ] [ Designated as safety issue: No ]
- physical examination [ Time Frame: screening ] [ Designated as safety issue: No ]
- electrocardiograms [ Time Frame: study completion ] [ Designated as safety issue: No ]
- vital sign measurements [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
| Enrollment: | 39 |
| Study Start Date: | August 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
patients will receive active MDX-1106 drug
|
Biological: MDX-1106
patients will receive a single dose of MDX-1106 at 0.3, 1.0, 3.0 or 10 mg/kg as a 90 minute infusion.
Other Name: MDX-1106
|
Detailed Description:
Six patients will be enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive additional doses of drug.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
- Prior treatment must have been completed at least 4 weeks prior to enrollment
- No untreated primary or metastatic brain or meningeal tumors
- ECOG PS 0 or 1
- Meet all screening laboratory values
Exclusion Criteria:
- History of severe hypersensitivity reactions to other monoclonal antibodies
- No active autoimmune disease or a documented history of autoimmune disease
- No prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
- No active infection
- No concomitant immunosuppressive medications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441337
Locations
| United States, Maryland | |
| Johns Hopkins Unv., School of Medicine | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| Washington University School of Medicine - Barnes Jewish Hospital | |
| St. Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| Carolina BioOncology Institute, PLLC | |
| Huntersville, North Carolina, United States, 28078 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00441337 History of Changes |
| Other Study ID Numbers: | MDX1106-01, CA209-001 |
| Study First Received: | February 27, 2007 |
| Last Updated: | April 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
malignancies cancer non small cell lung cancer lung cancer colorectal cancer adenocarcinoma melanoma |
malignant melanoma renal cancer renal carcinoma carcinoma prostate cancer prostate adenocarcinoma Recurrent or treatment refractory malignancies |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Kidney Neoplasms Colorectal Neoplasms Melanoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013