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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01338831
First Posted: April 20, 2011
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
April 14, 2011
April 20, 2011
March 1, 2017
September 2011
March 2014   (Final data collection date for primary outcome measure)
Incidence rate of Dose Limiting Toxicity [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT01338831 on ClinicalTrials.gov Archive Site
  • LFA102 serum concentration [ Time Frame: 6 months ]
  • Disease response [ Time Frame: every 2 to 3 months ]
  • Concentrations of antibodies to LFA102 [ Time Frame: every month ]
Same as current
Not Provided
Not Provided
 
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Castration-resistant Prostate Cancer
  • Metastatic Breast Cancer
  • Uterine Leiomyoma
Drug: LFA102
  • Experimental: Breast & Prostate Cancer Group
    Dose Escalation
    Intervention: Drug: LFA102
  • Experimental: Breast Cancer Group
    Dose Expansion
    Intervention: Drug: LFA102
  • Experimental: Prostate Cancer Group
    Dose Expansion
    Intervention: Drug: LFA102
  • Experimental: Uterine Leiomyoma Group
    Dose Expansion
    Intervention: Drug: LFA102
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
March 2014
March 2014   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   Spain,   United States
 
 
NCT01338831
CLFA102X2102
2011-000494-32 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP