A Phase I Study of LFA102 in Japanese Patients

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

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

Study Overview

• Status: Completed
• Conditions: Castration-resistant Prostate Cancer, Advanced Breast Cancer
• Intervention / Treatment: Drug: LFA102

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-city, Aichi, Japan, 466-8560
      • Novartis Investigative Site
  • Hyogo
    • Kobe-city, Hyogo, Japan, 650-0017
      • Novartis Investigative Site
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LFA102	Drug: LFA102; Other Names: anti prolactin receptor humanized monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicities (DLT)	Frequency and severity of dose limiting toxicities (DLTs)	1st treatment cycle (28 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimate): June 1, 2012

Study Record Updates

• Last Update Posted (Estimate): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 9, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: castration-resistant prostate cancer, advanced breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Breast Diseases; Prostatic Diseases; Breast Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: CLFA102X1101