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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Castration-resistant Prostate Cancer,, Metastatic Breast Cancer, Uterine Leiomyoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence rate of Dose Limiting Toxicity

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLFA102X2102

NCT ID:

NCT01338831

Start Date:

September 2011

Completion Date:

August 2013

Related Keywords:

  • Castration-resistant Prostate Cancer,
  • Metastatic Breast Cancer
  • Uterine Leiomyoma
  • prostate cancer,
  • breast cancer,
  • prolactin,
  • prolactin receptor
  • uterine leiomyoma
  • Breast Neoplasms
  • Leiomyoma
  • Myofibroma
  • Prostatic Neoplasms

Name

Location

Massachusetts General Hospital Mass Gen 3Boston, Massachusetts  02114
Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas JeffersonPhiladelphia, Pennsylvania  19107
University of Utah / Huntsman Cancer Institute Huntsman 3Salt Lake City, Utah  84103
University of Wisconsin Clinical Science CenterMadison, Wisconsin  53792
Cancer Institute of New Jersey SCNew Brunswick, New Jersey  08901