CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Temozolomide +4 moredrug
Likely dose
Temozolomide 75 mg/m2from 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/NCT00977431
NCT00977431Phase 1Completed
CompareCT.gov

Phase I, Open Label Trial to Explore Safety of Combining BIBW 2992 and Radiotherapy With or Without Temozolomide in Newly Diagnosed GBM

Boehringer Ingelheim·interventional·Posted Sep 15, 2009·Updated Feb 18, 2019

In Brief

A Phase 1 clinical trial evaluating Temozolomide, Radiotherapy, and 1 other intervention for Glioblastoma. Completed, enrolled 36 participants across 5 sites.

Detailed Summary

This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD), safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor receptor(EGFR)inhibitor) to be used in combination with: * radiotherapy alone (in patients with an unmethylated (functioning) MGMT gene regulator) or * radiotherapy and Temozolomide (in patients with a methylated (silenced) O6-methylguanine-DNA methyltransferase gene (MGMT) to treat newly diagnosed patients with Grade IV Glioblastoma (primary brain cancer).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2009
Enrollment StartSep 17, 2009
Primary CompletionSep 12, 2017
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 16.8 years ago

Interventions

Temozolomidedrug

During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6)

Radiotherapyprocedure

Day 1 to day 42

BIBW2992drug

Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT

Radiotherapyprocedure

Day 1 to day 42

BIBW2992drug

Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT