Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
Robert Natale, M.D.
Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center
United States: Food and Drug Administration
|Fountain Valley, California 92708|
|Columbia, Missouri 65203|
|Albany, New York 12208|
|Cleveland, Ohio 44195|
|Nashville, Tennessee 37203-1632|
|Omaha, Nebraska 68114|
|Albuquerque, New Mexico 87131-5636|