A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer
This is a phase I open-label, multi-center, dose escalation study in Japanese patients with
CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the
study. All patients will remain on treatment until they meet the criteria for study
discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or
study closure.
This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary
anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A
two-parameter Bayesian logistic regression model employing the escalation with overdose
control principle will be used during the escalation phase for dose level selection and for
determination of the MTD or RD.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicities (DLT)
Frequency and severity of dose limiting toxicities (DLTs)
1st treatment cycle (28 days)
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Japan: Pharmaceuticals and Medical Devices Agency
CLFA102X1101
NCT01610050
June 2012
August 2014
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