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RO4929097 in Treating Patients With Advanced, Metastatic, or Recurrent Breast Cancer

2014-08-27 03:12:37 | BioPortfolio

Summary

RATIONALE: RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II clinical trial is studying how well RO4929097 works in treating patients with advanced, metastatic, or recurrent breast cancer.

Description

OBJECTIVES:

Primary

- To assess the antitumor activity of gamma-secretase inhibitor RO4929097 in patients with advanced, metastatic, and/or recurrent triple-negative breast cancer through the co-primary endpoints of overall response rate using RECIST and 6-month progression-free survival (PFS).

Secondary

- To assess the antitumor activity of gamma-secretase inhibitor RO4929097 through secondary endpoints, including duration of radiologic response, PFS rate, and overall survival rate.

- To assess the safety and tolerability of gamma-secretase inhibitor RO4929097 in patients with breast cancer.

- To explore the expression of Notch biomarkers in triple-negative breast cancer and potential interaction with gamma-secretase inhibitor RO4929097 response and toxicity. (exploratory)

- To evaluate the downstream effects of gamma-secretase inhibitor RO4929097 in patients with advanced triple-negative breast cancer. (exploratory)

OUTLINE: This is a multicenter study.

Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo biopsy at baseline and at 4-5 weeks and blood samples are collected periodically for correlative laboratory studies.

After completion of study treatment, patients are followed up monthly for 12 months and then every 3 months thereafter.

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

gamma-secretase inhibitor RO4929097, laboratory biomarker analysis

Location

Tom Baker Cancer Centre - Calgary
Calgary
Alberta
Canada
T2N 4N2

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:37-0400

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Medical and Biotech [MESH] Definitions

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

Integral membrane protein of Golgi and endoplasmic reticulum. Its homodimer is an essential component of the gamma-secretase complex that catalyzes the cleavage of membrane proteins such as NOTCH RECEPTORS and AMYLOID BETA-PROTEIN precursors. PSEN2 mutations cause ALZHEIMER DISEASE type 4.

Integral membrane proteins and essential components of the gamma-secretase complex that catalyzes the cleavage of membrane proteins such as NOTCH RECEPTORS and AMYLOID BETA-PROTEIN precursors. Mutations of presenilins lead to presenile ALZHEIMER DISEASE with onset before age 65 years.

An analogue of GAMMA-AMINOBUTYRIC ACID. It is an irreversible inhibitor of 4-AMINOBUTYRATE TRANSAMINASE, the enzyme responsible for the catabolism of GAMMA-AMINOBUTYRIC ACID. (From Martindale The Extra Pharmacopoeia, 31st ed)

Endopeptidases that are specific for AMYLOID PROTEIN PRECURSOR. Three secretase subtypes referred to as alpha, beta, and gamma have been identified based upon the region of amyloid protein precursor they cleave.

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