Trial intelligence / Profile preview

SAHA (Vorinostat) in Relapsed Non-small Cell Lung Cancer

NCT00138203Phase 2

Key facts

Status: Completed
Start: Jun 2005
Primary completion: Dec 2008
Countries: 1
Sponsor: National Cancer Institute
Modality: Covalent Small Molecules, Classical Binding Small Molecules

Drugs: vorinostat
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label, single-arm trial of vorinostat in non-small cell lung cancer (NSCLC), sponsored by National Cancer Institute. Primary endpoint: Response Per RECIST Criteria. Started Jun 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Treatment (vorinostat)
Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days.

Who it enrols

Patients with Stage IV or Stage IIIB (with malignant pleural effusion) or recurrent NSCLC. Must have measurable disease and no more than 1 prior cytotoxic chemotherapy regimen. Brain metastases allowed if stable.

Endpoints

Primary

Response Per RECIST CriteriaTime from treatment initiation until the end of treatment

Secondary

Time to ProgressionFrom start of treatment to progression
Overall SurvivalFrom treatment start to time of death
ToxicityFrom first dose until 30 days from last dose

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