NCT00441337

A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer

Detailed description

Six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive additional doses of drug.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Malignant Melanoma
• Renal Cancer
• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	MDX-1106	patients will receive a single dose of MDX-1106 as a 60 minute infusion.

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-02-28
• Last updated: 2015-02-20
• Results posted: 2015-02-20

Locations

4 sites across 1 country: United States