At a glance
ClinicalIndex Comparison Record- ✓Histologic or cytologic confirmation of unresectable locally advanced (stage IIIB with pleural effusion) or metastatic (stage IV) NSCLC documented before first line therapy
- ✓Prior treatment with a platinum-containing regimen required
- ✓Age ≥18 years
- ✓WHO performance status 0-1
- ✕More than one prior chemotherapy regimen or other systemic antineoplastic treatment (including immunotherapy)
- ✕Any investigational compound within past 28 days or planned concurrent investigational drugs
- ✕Brain metastases patients: prior chemotherapy or systemic antineoplastic treatment for brain metastases
- ✕Brain metastases patients: dose increase of steroid or anticonvulsant therapy ≥25% within 14 days prior to entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Phase I/II Dose Escalating Study Evaluating the Safety and Efficacy of EPO906, qw3, in Patients With Non-small Cell Lung Cancer.
In Brief
A Phase 2 clinical trial evaluating Patupilone for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 89 participants across 4 sites.
Detailed Summary
The study objective is to evaluate the maximum tolerated dose, safety and efficacy of patupilone in patients with NSCLC who have progressed after prior chemotherapy.
Study Details
Timeline
Interventions
Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendment 2 and over 10 to 20 minutes (Amendment 2) till the completion of Phase I part of the study. Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks in Phase II part of the study.