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A Phase I Study of LFA102 in Japanese Patients

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ClinicalTrials.gov Identifier: NCT01610050
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : November 11, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer, Advanced Breast Cancer Drug: LFA102 Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 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 Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer
Study Start Date : June 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: LFA102 Drug: LFA102
Other Name: anti prolactin receptor humanized monoclonal antibody



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


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

  2. Serum Concentration [ Time Frame: cycle 1 day 1 until disease progression ]
  3. Objective Response Rate [ Time Frame: every 8 week or 12 weeks, until disase progression ]
    Assessed based on RECIST/PCWG2 criteria

  4. Antibodies against LFA102 [ Time Frame: day 1 of each treatment cycle until disease progression ]
    Serum concentration of antibodies against LFA102

  5. Progression Free Survival [ Time Frame: every 8 or 12 weeks until disease progression ]
    Assessed based on RECIST/PCWG2 criteria

  6. PK parameters [ Time Frame: cycle 1 day 1 until disease progression ]
    Cmax, Tmax, AUC, T1/2, CL and V



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01610050     History of Changes
Other Study ID Numbers: CLFA102X1101
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014

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

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