Clinical trial NCT01338831: Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Castration-resistant Prostate Cancer
Metastatic Breast Cancer
Uterine Leiomyoma
Keywords: prostate cancer,
breast cancer,
prolactin,
prolactin receptor
uterine leiomyoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of Dose Limiting Toxicity
timeFrame: 4 weeks
Secondary outcomes:
measure: LFA102 serum concentration
timeFrame: 6 months
measure: Disease response
timeFrame: every 2 to 3 months
measure: Concentrations of antibodies to LFA102
timeFrame: every month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Mass Gen 3
state: Massachusetts
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey SC
state: New Jersey
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah / Huntsman Cancer Institute Huntsman 3
state: Utah
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Agarwal N, Machiels JP, Suarez C, Lewis N, Higgins M, Wisinski K, Awada A, Maur M, Stein M, Hwang A, Mosher R, Wasserman E, Wu G, Zhang H, Zieba R, Elmeliegy M. Phase I Study of the Prolactin Receptor Antagonist LFA102 in Metastatic Breast and Castration-Resistant Prostate Cancer. Oncologist. 2016 May;21(5):535-6. doi: 10.1634/theoncologist.2015-0502. Epub 2016 Apr 18.