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

Primary Purpose

Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Uterine Leiomyoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LFA102
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Castration-resistant Prostate Cancer focused on measuring prostate cancer,, breast cancer,, prolactin,, prolactin receptor, uterine leiomyoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Mass Gen 3
  • Cancer Institute of New Jersey SC
  • Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson
  • University of Utah / Huntsman Cancer Institute Huntsman 3
  • University of Wisconsin Clinical Science Center
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Breast & Prostate Cancer Group

Breast Cancer Group

Prostate Cancer Group

Uterine Leiomyoma Group

Arm Description

Dose Escalation

Dose Expansion

Dose Expansion

Dose Expansion

Outcomes

Primary Outcome Measures

Incidence rate of Dose Limiting Toxicity

Secondary Outcome Measures

LFA102 serum concentration
Disease response
Concentrations of antibodies to LFA102

Full Information

First Posted
April 14, 2011
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01338831
Brief Title
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Uterine Leiomyoma
Keywords
prostate cancer,, breast cancer,, prolactin,, prolactin receptor, uterine leiomyoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast & Prostate Cancer Group
Arm Type
Experimental
Arm Description
Dose Escalation
Arm Title
Breast Cancer Group
Arm Type
Experimental
Arm Description
Dose Expansion
Arm Title
Prostate Cancer Group
Arm Type
Experimental
Arm Description
Dose Expansion
Arm Title
Uterine Leiomyoma Group
Arm Type
Experimental
Arm Description
Dose Expansion
Intervention Type
Drug
Intervention Name(s)
LFA102
Primary Outcome Measure Information:
Title
Incidence rate of Dose Limiting Toxicity
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
LFA102 serum concentration
Time Frame
6 months
Title
Disease response
Time Frame
every 2 to 3 months
Title
Concentrations of antibodies to LFA102
Time Frame
every month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma Detectable metastases by bone scan, CT-scan, or MRI. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only) Suitable venous access for blood sampling Exclusion Criteria: Prior treatment with any anti-prolactin receptor antibody Major surgery within 28 days before study treatment Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug Prior anaphylactic or other severe infusion reaction to antibody formulations Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital Mass Gen 3
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Cancer Institute of New Jersey SC
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Utah / Huntsman Cancer Institute Huntsman 3
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
University of Wisconsin Clinical Science Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27091421
Citation
Agarwal N, Machiels JP, Suarez C, Lewis N, Higgins M, Wisinski K, Awada A, Maur M, Stein M, Hwang A, Mosher R, Wasserman E, Wu G, Zhang H, Zieba R, Elmeliegy M. Phase I Study of the Prolactin Receptor Antagonist LFA102 in Metastatic Breast and Castration-Resistant Prostate Cancer. Oncologist. 2016 May;21(5):535-6. doi: 10.1634/theoncologist.2015-0502. Epub 2016 Apr 18.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13004
Description
Results for CLFA102X2102 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

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

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