- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00656734
Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer. (MDX1411-01)
May 13, 2013 updated by: Bristol-Myers Squibb
A Phase 1, Open-Label, Multicenter Dose-escalation, Multidose Study of MDX1411 Administered Every 14 Days in Subjects With Advanced or Recurrent Clear Cell Renal Cell Carcinoma
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
Study Overview
Detailed Description
Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study.
The maximum duration for the study is two and a half years for a total of 17 cycles.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconness Medical Center
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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Nevada
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Las Vegas, Nevada, United States, 89135
- Nevada Cancer Institute
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New York
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Bronx, New York, United States, 10466
- Montefiore Medical Center
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Oregon
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Portland, Oregon, United States, 97213
- Providence Portland Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed diagnosis of RCC with clear cell component
- Measurable disease
- Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
- Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
- At least 28 days since the last chemotherapy
- At least 28 days before the first dose of MDX 1411 since any major surgery
- ECOG performance status 0-2
- No known positivity for human immunodeficiency virus (HIV), Hep B or C
Exclusion Criteria:
- Previous treatment with any other anti-CD70 antibody
- Active infection requiring i.v systemic therapy within 28 days before first dose
- Evidence of bleeding diathesis or coagulopathy
- Active autoimmune disease requiring immunosuppressive therapy
- Known current drug or alcohol abuse
- Any underlying medical condition which will make the administration of MDX 1411 hazardous
- Psychiatric illness or social situation that would preclude study compliance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MDX 1411
Dose Escalation Cohorts
|
MDX-1411 (fully human monoclonal antibody) administered as an i.v.
infusion for up to 5 doses per cycle, with a maximum of 17 cycles total
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the safety profile of MDX 1411
Time Frame: duration of study
|
duration of study
|
Determine the maximum tolerated dose of MDX 1411
Time Frame: duration of study
|
duration of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the best overall response rate (BORR)
Time Frame: Day 38-42 of each cycle
|
Day 38-42 of each cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
April 3, 2008
First Submitted That Met QC Criteria
April 10, 2008
First Posted (Estimate)
April 11, 2008
Study Record Updates
Last Update Posted (Estimate)
May 14, 2013
Last Update Submitted That Met QC Criteria
May 13, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDX1411-01
- CA214-001 (Other Identifier: BMS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on MDX 1411
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-
Bristol-Myers SquibbWithdrawnLymphoma, Large-CellUnited States, France
-
Bristol-Myers SquibbCompletedRenal Cell Carcinoma | Non-hodgkin's LymphomaUnited States
-
Bristol-Myers SquibbCompletedHodgkin's LymphomasUnited States
-
Bristol-Myers SquibbCompletedChronic Lymphocytic LeukemiaUnited States
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Mallinckrodt ARD LLCTerminatedMuscular Dystrophy, DuchenneSpain, Bulgaria, Italy, United States, Mexico, Israel, Serbia, Turkey
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Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of... and other collaboratorsActive, not recruitingPathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHepatocellular Carcinoma | Resectable Hepatocellular CarcinomaUnited States
-
Shiraz University of Medical SciencesCompletedDiabetes Mellitus, Type 2 | Sleep DisturbanceIran, Islamic Republic of
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Kidney Medullary Carcinoma | Loss of INI 1 Protein ExpressionUnited States