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NCT01338831 Clinical Trial

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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01338831
Other study ID # CLFA102X2102
Secondary ID 2011-000494-32
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2011
Est. completion date March 2014

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LFA102

Locations
Country Name City State
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Bruxelles
Italy Novartis Investigative Site Modena MO
Spain Novartis Investigative Site Barcelona Catalunya
United States Massachusetts General Hospital Mass Gen 3 Boston Massachusetts
United States University of Wisconsin Clinical Science Center Madison Wisconsin
United States Cancer Institute of New Jersey SC New Brunswick New Jersey
United States Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson Philadelphia Pennsylvania
United States University of Utah / Huntsman Cancer Institute Huntsman 3 Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Italy,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate of Dose Limiting Toxicity 4 weeks
Secondary LFA102 serum concentration 6 months
Secondary Disease response every 2 to 3 months
Secondary Concentrations of antibodies to LFA102 every month
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