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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01338831
First received: April 14, 2011
Last updated: October 23, 2013
Last verified: October 2013
  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:


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 ]

Enrollment: 73
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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:

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1000
Novartis Investigative Site
Bruxelles, Belgium, 1200
Italy
Novartis Investigative Site
Modena, MO, Italy, 41100
Spain
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals 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: October 23, 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 August 27, 2014