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

Completed · Phase 1

Conditions studied: Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Uterine Leiomyoma

In brief

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.

Key facts

Study ID

NCT01338831

Run by

Novartis Pharmaceuticals

People needed

73

Starts

2011-09-01

Expected to finish

2014-03-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma
• Detectable metastases by bone scan, CT-scan, or MRI.
• Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
• Suitable venous access for blood sampling

You may not qualify if…

• Prior treatment with any anti-prolactin receptor antibody
• Major surgery within 28 days before study treatment
• Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
• Prior anaphylactic or other severe infusion reaction to antibody formulations
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Massachusetts General Hospital Mass Gen 3 — Boston, Massachusetts, 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, United States
• University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

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