CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
Sorafenibdrug
Likely dose
Sorafenib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00411671
NCT00411671Phase 2Completed
CompareCT.gov

A Phase II Study of Sorafenib (BAY 43-9006) in Chemorefractory Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

M.D. Anderson Cancer Center·interventional·Posted Dec 14, 2006·Updated Feb 11, 2016

In Brief

A Phase 2 clinical trial evaluating Sorafenib for Lung Cancer. Completed, enrolled 105 participants across 1 site.

Detailed Summary

Primary Objective: * To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen. Secondary Objective: The secondary objectives of this study will be to: * Determine the overall response rate * Determine the overall survival * Determine the time to disease progression * Assess the safety/toxicity of the study treatment * Assess biomarker modulation in the tumor tissue and serum samples from the treatment. * Assess plasma and intra-tumor concentrations of study treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsUnited States Department of Defense, Bayer

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2006
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 19.6 years ago

Interventions

Sorafenibdrug

400 mg By Mouth Twice Daily for 28 Days.