CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 217 enrolled
Drug / intervention
dasatinib +3 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/NCT00869401
NCT00869401Phase 2Completed

Phase I/Randomized Phase II Trial of Either Dasatinib or Placebo Combined With Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme (GBM)

Alliance for Clinical Trials in Oncology·interventional·Posted Mar 26, 2009·Updated Feb 13, 2020

In Brief

A Phase 2 clinical trial evaluating dasatinib, temozolomide, and 2 other interventions for Brain and Central Nervous System Tumors. Completed, enrolled 217 participants across 207 sites.

Detailed Summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. This randomized phase I/II trial is studying the best dose of dasatinib and to see how well it works compared with a placebo when given together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2009
Enrollment StartJun 1, 2009
Primary CompletionOct 1, 2014
Study CompletionNov 15, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.3 years ago

Interventions

dasatinibdrug

Given orally

temozolomidedrug

Given orally

placeboother

Given orally

radiation therapyradiation

Radiation therapy is performed as 30 fractions of 200 cGy for a total of 6000 cGy.