CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 169 enrolled
Drug / intervention
sorafenib tosylate +1 moredrug
Likely dose
Not stated in 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/NCT00602576
NCT00602576Phase 2Completed
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Randomized Phase II Study Comparing Two Schedules Of Temozolomide In Combination With Bay 43-9006 In Patients With Advanced Melanoma

Abramson Cancer Center at Penn Medicine·interventional·Posted Jan 28, 2008·Updated Jun 14, 2022

In Brief

A Phase 2 clinical trial evaluating sorafenib tosylate and temozolomide for Melanoma (Skin). Completed, enrolled 169 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving temozolomide together with sorafenib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different schedules of temozolomide when given together with sorafenib to compare how well they work in treating patients with metastatic or unresectable melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma (Skin)
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartJan 1, 2005
Primary CompletionDec 21, 2008
Study CompletionJul 26, 2009
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 18.4 years ago

Interventions

sorafenib tosylatedrug

Given orally

temozolomidedrug

Given orally