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

Kidney Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656734
• Other study ID #: MDX1411-01
• Secondary ID: CA214-001
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2008
• Last updated: May 13, 2013
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety profile of MDX 1411		duration of study	Yes
Primary	Determine the maximum tolerated dose of MDX 1411		duration of study	Yes
Secondary	Determine the best overall response rate (BORR)		Day 38-42 of each cycle	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm