NCT01338831

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

Typical duration for phase_1

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 17, 2020

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

April 14, 2011

Last Update Submit

December 16, 2020

Conditions

Castration-resistant Prostate CancerMetastatic Breast CancerUterine Leiomyoma

Keywords

prostate cancer,breast cancer,prolactin,prolactin receptoruterine leiomyoma

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of Dose Limiting Toxicity

    4 weeks

Secondary Outcomes (3)

  • LFA102 serum concentration

    6 months

  • Disease response

    every 2 to 3 months

  • Concentrations of antibodies to LFA102

    every month

Study Arms (4)

Breast & Prostate Cancer Group

EXPERIMENTAL

Dose Escalation

Drug: LFA102

Breast Cancer Group

EXPERIMENTAL

Dose Expansion

Drug: LFA102

Prostate Cancer Group

EXPERIMENTAL

Dose Expansion

Drug: LFA102

Uterine Leiomyoma Group

EXPERIMENTAL

Dose Expansion

Drug: LFA102

Interventions

LFA102DRUG
Breast & Prostate Cancer GroupBreast Cancer GroupProstate Cancer GroupUterine Leiomyoma Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Massachusetts General Hospital Mass Gen 3

Boston, Massachusetts, 02114, United States

Location

Cancer Institute of New Jersey SC

New Brunswick, New Jersey, 08901, United States

Location

Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson

Philadelphia, Pennsylvania, 19107, United States

Location

University of Utah / Huntsman Cancer Institute Huntsman 3

Salt Lake City, Utah, 84103, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

Novartis Investigative Site

Brussels, 1000, Belgium

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27091421DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsMyofibromaProstatic Neoplasms

Interventions

LFA102 monoclonal antibody

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeConnective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 20, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 17, 2020

Record last verified: 2017-02

Locations

ES(1)IT(1)BE(2)US(5)