CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
sorafenib tosylatedrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed recurrent DLBCL or variants (centroblastic, immunoblastic, T-cell/histiocyte rich, anaplastic) per WHO classification
  • ✓ECOG performance status 0 or 1
  • ✓Measurable disease assessed within 4 weeks of registration
  • ✓Failed one or more prior NHL chemotherapy or antibody therapy with curative intent (autologous stem cell transplant permitted)
Key exclusion· 9
  • ✕CNS involvement
  • ✕Previously treated with sorafenib or other MAPK/angiogenesis inhibitors (e.g., bevacizumab)
  • ✕Progressed within 60 days of last therapy
  • ✕Prior allogeneic stem cell transplant

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

Search/NCT00131937
NCT00131937Phase 2Completed
CompareCT.gov

A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)·interventional·Posted Aug 19, 2005·Updated Sep 3, 2015

In Brief

A Phase 2 clinical trial evaluating sorafenib tosylate for Anaplastic Large Cell Lymphoma and 7 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2005
Enrollment StartOct 1, 2005
Primary CompletionSep 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.9 years ago

Interventions

sorafenib tosylatedrug

Given orally