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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

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ClinicalTrials.gov Identifier: NCT01338831
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Metastatic Breast Cancer Uterine Leiomyoma Drug: LFA102 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2011
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Prolactin
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Incidence rate of Dose Limiting Toxicity [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. LFA102 serum concentration [ Time Frame: 6 months ]
  2. Disease response [ Time Frame: every 2 to 3 months ]
  3. Concentrations of antibodies to LFA102 [ Time Frame: every month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338831

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01338831     History of Changes
Other Study ID Numbers: CLFA102X2102
2011-000494-32 ( EudraCT Number )
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
prostate cancer,
breast cancer,
prolactin receptor
uterine leiomyoma

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases