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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDX 1411
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring Medarex Inc.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconness Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Nevada Cancer Institute
  • Montefiore Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Providence Portland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDX 1411

Arm Description

Dose Escalation Cohorts

Outcomes

Primary Outcome Measures

Determine the safety profile of MDX 1411
Determine the maximum tolerated dose of MDX 1411

Secondary Outcome Measures

Determine the best overall response rate (BORR)

Full Information

First Posted
April 3, 2008
Last Updated
May 13, 2013
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00656734
Brief Title
Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.
Acronym
MDX1411-01
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
Medarex Inc.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MDX 1411
Arm Type
Experimental
Arm Description
Dose Escalation Cohorts
Intervention Type
Biological
Intervention Name(s)
MDX 1411
Intervention Description
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
Primary Outcome Measure Information:
Title
Determine the safety profile of MDX 1411
Time Frame
duration of study
Title
Determine the maximum tolerated dose of MDX 1411
Time Frame
duration of study
Secondary Outcome Measure Information:
Title
Determine the best overall response rate (BORR)
Time Frame
Day 38-42 of each cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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