Trial intelligence / Profile preview

RO4929097 with Radiotherapy for Brain Metastases

NCT01217411Phase 2

Key facts

Status: Terminated
Start: Oct 2010
Primary completion: Nov 2011
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: RO4929097
Conditions: brain metastasesbreast cancer

Overview

Phase 2, randomised, open-label trial of RO4929097 in brain metastases and breast cancer (2 arms), sponsored by National Cancer Institute. Primary endpoints: Maximum-tolerated Dose at 4 weeks, Safety Profile of RO4929097 and 1 more. Started Oct 2010; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Control
WBRT or SRS alone
Experimental
RO4929097 + WBRT or SRS

Who it enrols

Patients with brain metastases from solid tumors (Phase I) or ER-negative breast cancer (Phase II), KPS >= 70, adequate organ function, and no prior Notch inhibitors.

Endpoints

Primary

Maximum-tolerated Dose4 weeks
Safety Profile of RO4929097
Response Rate (Complete or Partial Response)12 weeks

Secondary

Progression Free Survival in the Brain
Percentage of Patients Alive and Disease Free (in the Brain)6 months
Local Control Rate in the Brain48 weeks
Distant Failure Rate in the Brain48 weeks
Progression Free Survival in the Body
Systemic Response Rate
Neurocognitive Outcomes

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