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

Purpose

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.

Condition	Intervention	Phase
Castration-resistant Prostate Cancer, Metastatic Breast Cancer Uterine Leiomyoma	Drug: LFA102	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Prostate Cancer

Drug Information available for: Prolactin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence rate of Dose Limiting Toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

LFA102 serum concentration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Disease response [ Time Frame: every 2 to 3 months ] [ Designated as safety issue: No ]
Concentrations of antibodies to LFA102 [ Time Frame: every month ] [ Designated as safety issue: No ]

Estimated Enrollment:	63
Study Start Date:	September 2011
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338831

Contacts

Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations

United States, Massachusetts
Massachusetts General Hospital Mass Gen 3	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michaela Higgins 617-724-3118 mjhiggins@partners.org
Principal Investigator: Michaela Higgins
United States, New Jersey
Cancer Institute of New Jersey SC	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Alicia Rivera 732-235-8996 beeral@umdnj.edu
Principal Investigator: Mark N. Stein
United States, Pennsylvania
Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Neethu Tharu 215-503-5712 neethu.tharu@jefferson.edu
Principal Investigator: Nancy L. Lewis
United States, Utah
University of Utah / Huntsman Cancer Institute Huntsman 3	Recruiting
Salt Lake City, Utah, United States, 84103
Contact: Chelsea Welch 801-587-4765 Chelsea.welch@hci.utah.edu
Principal Investigator: Neeral Agarwal
United States, Wisconsin
University of Wisconsin Clinical Science Center	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jennifer Heideman 608-263-1387 Phase1@medicine.wisc.edu
Principal Investigator: Glenn Liu
Belgium
Novartis Investigative Site	Recruiting
Bruxelles, Belgium, 1000
Novartis Investigative Site	Recruiting
Bruxelles, Belgium, 1200
Italy
Novartis Investigative Site	Recruiting
Modena, MO, Italy, 41100
Spain
Novartis Investigative Site	Recruiting
Barcelona, Cataluna, Spain, 08035

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01338831 History of Changes
Other Study ID Numbers:	CLFA102X2102, 2011-000494-32
Study First Received:	April 14, 2011
Last Updated:	May 17, 2013
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Italy: Ministry of Health Spain: Ministry of Health

Keywords provided by Novartis:

prostate cancer,
breast cancer,
prolactin,
prolactin receptor
uterine leiomyoma

Additional relevant MeSH terms:

Breast Neoplasms
Leiomyoma
Myofibroma
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Muscle Tissue

Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013