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

NCT00656734 | Completed Phase 1

• 2 other identifiers: MDX1411-01CA214-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Kidney Cancer

Keywords

Medarex Inc.

Outcome Measures

Primary Outcomes (2)

• Determine the safety profile of MDX 1411

  duration of study

• Determine the maximum tolerated dose of MDX 1411

  duration of study

Secondary Outcomes (1)

• Determine the best overall response rate (BORR)

  Day 38-42 of each cycle

Study Arms (1)

MDX 1411

EXPERIMENTAL

Dose Escalation Cohorts

Biological: MDX 1411

Interventions

MDX 1411 BIOLOGICAL

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

MDX 1411

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10466, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 11, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

US (7)