Trial intelligence / Profile preview

Temozolomide for Brain Metastases from Melanoma, Breast, and NSCLC

NCT00831545Phase 2

Key facts

Status: Completed
Start: Dec 2000
Primary completion: Oct 2006
Sponsor: Merck & Co.
Modality: Small Molecules

Drugs: temozolomide
Conditions: brain metastases

Overview

Phase 2, open-label trial of temozolomide in brain metastases (3 arms), sponsored by Merck & Co. Primary endpoint: Best response related to brain metastases at 2 months. Started Dec 2000; status: completed.

Design

3 arms

Study design: Non-randomizedOpen-label

Melanoma
Temozolomide treatment
Breast Cancer
Temozolomide treatment
NSCLC
Temozolomide treatment

Who it enrols

Patients with brain metastases from melanoma, breast cancer, or NSCLC, age <=70, ECOG 0-2, adequate organ function, no prior whole brain irradiation, and not eligible for neurosurgery or stereotactic radiation.

Endpoints

Primary

Best response related to brain metastases2 months

Secondary

Progression-free survival2 months
Overall survival2 months
Adverse eventsThroughout the study

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