A Phase I Study of LFA102 in Japanese Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Castration-resistant Prostate Cancer, Advanced Breast Cancer

Treatments: Drug: LFA102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01610050

CLFA102X1101

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of prostate cancer
• Histologically or cytologically confirmed locally advanced or metastatic breast cancer

Exclusion criteria

• Patients with untreated and/or symptomatic metastatic CNS disease
• Prior anaphylactic or other severe infusion reaction
• Treatment with agent which affect prolactin levels
• Active autoimmune disease

Other protcol-defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

LFA102

Experimental group

Treatment:

Drug: LFA102