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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01338831

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

8.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Castration-resistant Prostate Cancer Metastatic Breast Cancer Uterine Leiomyoma	Drug: LFA102	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breast & Prostate Cancer Group Dose Escalation	Drug: LFA102
Experimental: Breast Cancer Group Dose Expansion	Drug: LFA102
Experimental: Prostate Cancer Group Dose Expansion	Drug: LFA102
Experimental: Uterine Leiomyoma Group Dose Expansion	Drug: LFA102

Outcome Measures

Primary Outcome Measures

Incidence rate of Dose Limiting Toxicity [4 weeks]

Secondary Outcome Measures

LFA102 serum concentration [6 months]
Disease response [every 2 to 3 months]
Concentrations of antibodies to LFA102 [every month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital Mass Gen 3	Boston	Massachusetts	United States	02114
2	Cancer Institute of New Jersey SC	New Brunswick	New Jersey	United States	08901
3	Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson	Philadelphia	Pennsylvania	United States	19107
4	University of Utah / Huntsman Cancer Institute Huntsman 3	Salt Lake City	Utah	United States	84103
5	University of Wisconsin Clinical Science Center	Madison	Wisconsin	United States	53792
6	Novartis Investigative Site	Bruxelles		Belgium	1000
7	Novartis Investigative Site	Bruxelles		Belgium	1200
8	Novartis Investigative Site	Modena	MO	Italy	41100
9	Novartis Investigative Site	Barcelona	Catalunya	Spain	08035