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A Phase I Study of LFA102 in Japanese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01610050
First received: May 30, 2012
Last updated: November 9, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Castration-resistant Prostate Cancer, Advanced Breast Cancer
Drug: LFA102
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Dose Limiting Toxicities (DLT) [ Time Frame: 1st treatment cycle (28 days) ] [ Designated as safety issue: Yes ]
    Frequency and severity of dose limiting toxicities (DLTs)


Secondary Outcome Measures:
  • Frequency, duration and severity of Adverse Events (AEs) [ Time Frame: at informed consent, until 28 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
    Frequency, duration and severity of all AEs will be collected.

  • Serum Concentration [ Time Frame: cycle 1 day 1 until disease progression ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: every 8 week or 12 weeks, until disase progression ] [ Designated as safety issue: No ]
    Assessed based on RECIST/PCWG2 criteria

  • Antibodies against LFA102 [ Time Frame: day 1 of each treatment cycle until disease progression ] [ Designated as safety issue: No ]
    Serum concentration of antibodies against LFA102

  • Progression Free Survival [ Time Frame: every 8 or 12 weeks until disease progression ] [ Designated as safety issue: No ]
    Assessed based on RECIST/PCWG2 criteria

  • PK parameters [ Time Frame: cycle 1 day 1 until disease progression ] [ Designated as safety issue: No ]
    Cmax, Tmax, AUC, T1/2, CL and V


Enrollment: 14
Study Start Date: June 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFA102 Drug: LFA102
Other Name: anti prolactin receptor humanized monoclonal antibody

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610050

Locations
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01610050     History of Changes
Other Study ID Numbers: CLFA102X1101
Study First Received: May 30, 2012
Last Updated: November 9, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
castration-resistant prostate cancer, advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Breast Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014