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 3 |
Boston, Massachusetts 02114 |
Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson |
Philadelphia, Pennsylvania 19107 |
University of Utah / Huntsman Cancer Institute Huntsman 3 |
Salt Lake City, Utah 84103 |
University of Wisconsin Clinical Science Center |
Madison, Wisconsin 53792 |
Cancer Institute of New Jersey SC |
New Brunswick, New Jersey 08901 |