NCT00129844

Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.

Detailed description

Outline: Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms: Arm A - 10 mg/kg MGd once per week Arm B - 15 mg/kg MGd once every 3 weeks Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study. At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.

Conditions

• Adenocarcinoma
• Non-Small-Cell Lung Carcinoma
• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Motexafin Gadolinium

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-06-01
• Completion: 2007-12-01
• First posted: 2005-08-12
• Last updated: 2008-08-20

Locations

16 sites across 2 countries: United States, Canada