Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

December 16, 2020 updated by: Novartis Pharmaceuticals

A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1000
        • Novartis Investigative Site
  • Italy
    • MO
      • Modena, MO, Italy, 41100
        • Novartis Investigative Site
  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Mass Gen 3
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute of New Jersey SC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • University of Utah / Huntsman Cancer Institute Huntsman 3
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Clinical Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma
  2. Detectable metastases by bone scan, CT-scan, or MRI.
  3. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
  4. Suitable venous access for blood sampling

Exclusion Criteria:

  1. Prior treatment with any anti-prolactin receptor antibody
  2. Major surgery within 28 days before study treatment
  3. Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
  4. Prior anaphylactic or other severe infusion reaction to antibody formulations

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast & Prostate Cancer Group
Dose Escalation
Drug: LFA102
Experimental: Breast Cancer Group
Dose Expansion
Drug: LFA102
Experimental: Prostate Cancer Group
Dose Expansion
Drug: LFA102
Experimental: Uterine Leiomyoma Group
Dose Expansion
Drug: LFA102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of Dose Limiting Toxicity
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
LFA102 serum concentration
Time Frame: 6 months
6 months
Disease response
Time Frame: every 2 to 3 months
every 2 to 3 months
Concentrations of antibodies to LFA102
Time Frame: every month
every month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLFA102X2102
  • 2011-000494-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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