This is an open-label dose escalation trial using ABI-007 plus carboplatin.
This is a multicenter study conducted at study sites in Russia and the Ukraine where various doses of ABI-007 (Abraxane) will be given in combination with carboplatin to patients with non-small cell lung cancer to determine the recommended dose and schedule for this combination therapy for Phase III trials. The primary objective of this study is to obtain preliminary information on the antitumor activity and adverse events of ABI-007 in combination with carboplatin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
ABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks
Study Sites in Russia
Saint Petersburg, Sankt-Peterburg, Russia
Safety Outcomes: incidence of treatment emergent adverse events.
Time frame: Treatment duration
Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response
Time frame: Treatment duration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.