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A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Castration-resistant Prostate Cancer, Advanced Breast Cancer

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Trial Information

A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicities (DLT)

Outcome Description:

Frequency and severity of dose limiting toxicities (DLTs)

Outcome Time Frame:

1st treatment cycle (28 days)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CLFA102X1101

NCT ID:

NCT01610050

Start Date:

June 2012

Completion Date:

August 2014

Related Keywords:

  • Castration-resistant Prostate Cancer, Advanced Breast Cancer
  • castration-resistant prostate cancer, advanced breast cancer
  • Breast Neoplasms
  • Prostatic Neoplasms

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