NCT00132379

ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer

An Open-label, Phase I, Dose-escalation Study of ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug, in combination with docetaxel (an approved drug for treating non-small cell lung cancer \[NSCLC\]), can be given to patients with NSCLC without causing unacceptable side effects.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	ABR-217620	10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles
DRUG	docetaxel	75mg/m\^2, IV, single 60 minute infusion, beginning on Day 5 then every third week

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-08-22
• Last updated: 2014-08-27

Locations

4 sites across 3 countries: United States, Denmark, Russia