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Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer. (MDX1411-01)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656734
First Posted: April 11, 2008
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).

Condition Intervention Phase
Kidney Cancer Biological: MDX 1411 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Determine the safety profile of MDX 1411 [ Time Frame: duration of study ]
  • Determine the maximum tolerated dose of MDX 1411 [ Time Frame: duration of study ]

Secondary Outcome Measures:
  • Determine the best overall response rate (BORR) [ Time Frame: Day 38-42 of each cycle ]

Enrollment: 27
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDX 1411
Dose Escalation Cohorts
Biological: MDX 1411
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656734


Locations
United States, Massachusetts
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10466
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00656734     History of Changes
Other Study ID Numbers: MDX1411-01
CA214-001 ( Other Identifier: BMS )
First Submitted: April 3, 2008
First Posted: April 11, 2008
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Bristol-Myers Squibb:
Medarex Inc.

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type