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:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00656734
First received: April 3, 2008
Last updated: May 13, 2013
Last verified: May 2013

April 3, 2008
May 13, 2013
April 2008
June 2010   (final data collection date for primary outcome measure)
  • Determine the safety profile of MDX 1411 [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • Determine the maximum tolerated dose of MDX 1411 [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Safety and Tolerability [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00656734 on ClinicalTrials.gov Archive Site
Determine the best overall response rate (BORR) [ Time Frame: Day 38-42 of each cycle ] [ Designated as safety issue: No ]
Best overall response rate (BORR)and progression-free survivl (PFS) [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.
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).

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
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
Experimental: MDX 1411
Dose Escalation Cohorts
Intervention: Biological: MDX 1411
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00656734
MDX1411-01, CA214-001
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP