Trial information
A Study of Epothilone D in Patients With Non-Small Cell Lung Cancer (NSCLC)
Status: Completed
Protocol number: NO17352
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of repeated cycles of intravenous Epothilone D on treatment response in patients with non-small-cell lung cancer who have progressed following initial therapy for advanced or metastatic disease
Brief summary: This study will assess the efficacy and safety of repeated cycles of intravenous Epothilone D in patients with NSCLC who have progressed after initial therapy for advanced or metastatic disease. The anticipated time on study treatment is until disease progression and the target sample size is <100 individuals.
Target sample size is 55.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Single Group; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: Epothilone D
Primary outcome: 1. Efficacy: Response rate, duration of response and time to tumor progression
Key secondary outcomes: 1. Safety: Adverse events, neurological evaluations,and laboratory tests
Inclusion criteria:
- adult patients >=18 years of age;
- histologically or cytologically proven NSCLC;
- previous surgical resection and/or radiotherapy for initial disease;
- failure (progression or toxicity) of 1 previous platinum-containing chemotherapy regimen for advanced or metastatic disease.
Exclusion criteria:
- women who are pregnant or breast-feeding, or patients unwilling to use an effective contraceptive method;
- central nervous system metastases;
- pre-existing neuropathy;
- previous malignancy, unless free of recurrence for at least 5 years.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
