A Phase I Study of LFA102 in Japanese Patients

Phase 1

Completed

• Conditions: Castration-resistant Prostate Cancer, Advanced Breast Cancer
• Interventions: Drug: LFA102

• Registration Number: NCT01610050
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-31
• Study Start: 2012-06
• Study First Posted: 2012-06-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-09
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LFA102	LFA102	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLT)	1st treatment cycle (28 days)	Frequency and severity of dose limiting toxicities (DLTs)

Secondary Outcome Measures

Name	Time	Method
PK parameters	cycle 1 day 1 until disease progression	Cmax, Tmax, AUC, T1/2, CL and V
Objective Response Rate	every 8 week or 12 weeks, until disase progression	Assessed based on RECIST/PCWG2 criteria
Frequency, duration and severity of Adverse Events (AEs)	at informed consent, until 28 days after treatment discontinuation	Frequency, duration and severity of all AEs will be collected.
Antibodies against LFA102	day 1 of each treatment cycle until disease progression	Serum concentration of antibodies against LFA102
Serum Concentration	cycle 1 day 1 until disease progression
Progression Free Survival	every 8 or 12 weeks until disease progression	Assessed based on RECIST/PCWG2 criteria

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Chuo-ku, Tokyo, Japan