NCT01151449

Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced, Metastatic, or Recurrent Triple Negative Invasive Breast Cancer

A Phase II Study of RO4929097 (IND 109291) in Advanced, Metastatic, or Recurrent Triple Negative Invasive Breast Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical trial studies how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with advanced, metastatic, or recurrent triple negative invasive breast cancer. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To assess the antitumour activity of RO4929097 in recurrent and/or metastatic triple negative breast cancer through co-primary endpoints of overall response rate (ORR) using RECIST and 6-month progression-free survival rate (PFS). SECONDARY OBJECTIVES: I. To assess the antitumour activity of RO4929097 through secondary endpoints including: duration of radiologic response, progression-free and overall survival rates within the protocol defined follow-up period. II. To assess the safety and tolerability of single agent RO4929097 in breast cancer. III. To explore expression of Notch biomarkers in triple negative breast cancer and potential interaction with RO4929097 response and toxicity. IV. To evaluate the downstream effects of RO4929097 in advanced triple negative breast cancer. OUTLINE: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Estrogen Receptor-negative Breast Cancer
• HER2-negative Breast Cancer
• Male Breast Cancer
• Progesterone Receptor-negative Breast Cancer
• Recurrent Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer
• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	gamma-secretase/Notch signalling pathway inhibitor RO4929097	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-07-01
• Completion: 2015-08-01
• First posted: 2010-06-28
• Last updated: 2017-04-11
• Results posted: 2017-04-11

Locations

2 sites across 1 country: Canada