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

Phase 1

Completed

• Conditions: Uterine Leiomyoma; Metastatic Breast Cancer; Castration-resistant Prostate Cancer
• Interventions: Drug: LFA102

• Registration Number: NCT01338831
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Study Start: 2011-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-02
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast & Prostate Cancer Group	LFA102	Dose Escalation
Uterine Leiomyoma Group	LFA102	Dose Expansion
Breast Cancer Group	LFA102	Dose Expansion
Prostate Cancer Group	LFA102	Dose Expansion

Primary Outcome Measures

Name	Time	Method
Incidence rate of Dose Limiting Toxicity	4 weeks

Secondary Outcome Measures

Name	Time	Method
Concentrations of antibodies to LFA102	every month
LFA102 serum concentration	6 months
Disease response	every 2 to 3 months

Trial Locations

Locations (6)

Massachusetts General Hospital Mass Gen 3; 🇺🇸 Boston, Massachusetts, United States

Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Wisconsin Clinical Science Center; 🇺🇸 Madison, Wisconsin, United States

Novartis Investigative Site; 🇪🇸 Barcelona, Catalunya, Spain

University of Utah / Huntsman Cancer Institute Huntsman 3; 🇺🇸 Salt Lake City, Utah, United States

Cancer Institute of New Jersey SC; 🇺🇸 New Brunswick, New Jersey, United States