A Phase I Study of LFA102 in Japanese Patients

Castration-resistant Prostate Cancer, Advanced Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610050
• Other study ID #: CLFA102X1101
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2012
• Last updated: November 9, 2014
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Castration-resistant Prostate Cancer, Advanced Breast Cancer
• Prostatic Neoplasms

Intervention

Drug:
• LFA102

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Nagoya-city	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLT)	Frequency and severity of dose limiting toxicities (DLTs)	1st treatment cycle (28 days)	Yes
Secondary	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	Yes
Secondary	Serum Concentration		cycle 1 day 1 until disease progression	No
Secondary	Objective Response Rate	Assessed based on RECIST/PCWG2 criteria	every 8 week or 12 weeks, until disase progression	No
Secondary	Antibodies against LFA102	Serum concentration of antibodies against LFA102	day 1 of each treatment cycle until disease progression	No
Secondary	Progression Free Survival	Assessed based on RECIST/PCWG2 criteria	every 8 or 12 weeks until disease progression	No
Secondary	PK parameters	Cmax, Tmax, AUC, T1/2, CL and V	cycle 1 day 1 until disease progression	No