Spots Global Cancer Trial Database for A Phase I Study of LFA102 in Japanese Patients

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Trial Identification

Brief Title: A Phase I Study of LFA102 in Japanese Patients

Official Title: A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer

Study ID: NCT01610050

Conditions

Castration-resistant Prostate Cancer, Advanced Breast Cancer

Interventions

LFA102

Study Description

Brief Summary: This study will evaluate safety and tolerability to determine the MTD/RD.

Detailed Description: 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.