A Phase I Study of LFA102 in Japanese Patients | NCT01610050

Studies
A Phase I Study of LFA102 in Japanese Patients

NCT01610050

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Nov 11, 2014Estimated

Enrollment

14Actual

Phase

Phase 1

Conditions

Castration-resistant Prostate Cancer, Advanced Breast Cancer

Interventions

LFA102

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

May 30, 2012

First Submission Date that Met QC Criteria

May 31, 2012

First Posted Date

Jun 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure.

This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Label	Type	Description	Intervention Names
LFA102	Experimental		Drug: LFA102

Name	Type	Description	Arm Group Labels	Other Names
LFA102	Drug		LFA102	anti prolactin receptor humanized monoclonal antibody

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose Limiting Toxicities (DLT)	Frequency and severity of dose limiting toxicities (DLTs)	1st treatment cycle (28 days)

Secondary Outcomes

Measure	Description	Time Frame
Frequency, duration and severity of Adverse Events (AEs)	Frequency, duration and severity of all AEs will be collected.	at informed consent, until 28 days after treatment discontinuation
Serum Concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protcol-defined Inclusion/Exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Nagoya	Aichi-ken	466-8560	Japan
Novartis Investigative Site

Intervention Browse Module

MeSH Terms

ID	Term
C583731	LFA102 monoclonal antibody

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided