CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 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/NCT00810394
NCT00810394Phase 2Completed
CompareCT.gov

Single Agent Sorafenib in Advanced Solid Tumors: Phase II Evaluation of Dose Re-Escalation Following a Dose Reduction (IST000375)

University of California, Davis·interventional·Posted Dec 18, 2008·Updated Jan 10, 2018

In Brief

A Phase 2 clinical trial evaluating Sorafenib for Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 50 participants across 1 site.

Detailed Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to see how well it works in treating patients with advanced malignant solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2008
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.5 years ago

Interventions

Sorafenibdrug

Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.