CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
sorafenib tosylatedrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically or cytologically-confirmed small cell lung cancer with extensive disease and progression or recurrence after one platinum-based chemotherapy regimen (cisplatin or carboplatin)
  • ✓Platinum-sensitive disease (initial response to platinum, progression >90 days after last platinum treatment) OR platinum-refractory disease (no response, progression during, or progression within 90 days of platinum therapy)
  • ✓Measurable disease per RECIST criteria documented within 28 days prior to registration
  • ✓Zubrod performance status 0-1
Key exclusion· 6
  • ✕Uncontrolled cardiac disease: uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, or cardiac ventricular arrhythmias requiring medication
  • ✕Evidence of bleeding diathesis
  • ✕Ongoing requirement for systemic corticosteroid therapy (topical and inhaled steroids allowed)
  • ✕Brain and/or leptomeningeal metastases if symptomatic, with neurologic deficits, or requiring corticosteroid therapy; patients on enzyme-inducing anticonvulsants are excluded

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

Search/NCT00182689
NCT00182689Phase 2Completed
CompareCT.gov

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer

National Cancer Institute (NCI)·interventional·Posted Sep 16, 2005·Updated May 21, 2014

In Brief

A Phase 2 clinical trial evaluating sorafenib tosylate for Extensive Stage Small Cell Lung Cancer and Recurrent Small Cell Lung Cancer. Completed, enrolled 89 participants across 1 site.

Detailed Summary

This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJul 1, 2005
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

sorafenib tosylatedrug

Given orally