NCT01610050

Brief Summary

This study will evaluate safety and tolerability to determine the MTD/RD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

May 30, 2012

Last Update Submit

November 9, 2014

Conditions

Castration-resistant Prostate Cancer, Advanced Breast Cancer

Keywords

castration-resistant prostate cancer, advanced breast cancer

Outcome Measures

Primary Outcomes (1)

  • Dose Limiting Toxicities (DLT)

    Frequency and severity of dose limiting toxicities (DLTs)

    1st treatment cycle (28 days)

Secondary Outcomes (6)

  • Frequency, duration and severity of Adverse Events (AEs)

    at informed consent, until 28 days after treatment discontinuation

  • Serum Concentration

    cycle 1 day 1 until disease progression

  • Objective Response Rate

    every 8 week or 12 weeks, until disase progression

  • Antibodies against LFA102

    day 1 of each treatment cycle until disease progression

  • Progression Free Survival

    every 8 or 12 weeks until disease progression

  • +1 more secondary outcomes

Study Arms (1)

LFA102

EXPERIMENTAL
Drug: LFA102

Interventions

LFA102DRUG
Also known as: anti prolactin receptor humanized monoclonal antibody
LFA102

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of prostate cancer
  • Histologically or cytologically confirmed locally advanced or metastatic breast cancer

You may not qualify if:

  • Patients with untreated and/or symptomatic metastatic CNS disease
  • Prior anaphylactic or other severe infusion reaction
  • Treatment with agent which affect prolactin levels
  • Active autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 104-0045, Japan

Location

MeSH Terms

Interventions

LFA102 monoclonal antibody

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 1, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

JP(3)