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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 is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01338831
First received: April 14, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes

April 14, 2011
May 17, 2013
September 2011
August 2013   (final data collection date for primary outcome measure)
Incidence rate of Dose Limiting Toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01338831 on ClinicalTrials.gov Archive Site
  • 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 ]
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: 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.
 
Recruiting
63
August 2013
August 2013   (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
Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Belgium,   Italy,   Spain
 
NCT01338831
CLFA102X2102, 2011-000494-32
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2013

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