A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy
This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of
SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until
progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm
Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part
will be initiated.
In the Randomized Part approximately 200 patients (100 per arm) will be randomized to
receive SPI-1620 plus docetaxel or docetaxel alone.
In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel
75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the
control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate(ORR) of SPI-1620
To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC
Up to 2 years
David M Waterhouse, MD, MPH
Oncology Hematology Care Inc.
United States: Food and Drug Administration
|Oncology Hematology Care Inc.||Cincinnati, Ohio 45242|
|Virginia Cancer Institute||Richmond, Virginia 23230|