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A Phase I Study of LFA102 in Japanese Patients

NCT ID: NCT01610050

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Castration-resistant Prostate Cancer, Advanced Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LFA102

Group Type EXPERIMENTAL

LFA102

Intervention Type DRUG

Interventions

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LFA102

Intervention Type DRUG

Other Intervention Names

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anti prolactin receptor humanized monoclonal antibody

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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CLFA102X1101

Identifier Type: -

Identifier Source: org_study_id