At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 151 enrolled

Drug / intervention

BIBW 2992 +2 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/NCT00727506

NCT00727506Phase 2Completed

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Phase I/II Trial of BIBW 2992 (Afatinib) in Treating Patients With Recurrent Glioblastoma Multiforme

Boehringer Ingelheim·interventional·Posted Aug 4, 2008·Updated Aug 15, 2017

In Brief

A Phase 2 clinical trial evaluating BIBW 2992, TMZ, and 1 other intervention for Glioma. Completed, enrolled 151 participants across 28 sites in 2 countries.

Detailed Summary

Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV). Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGlioma

CountriesCanada, United States

Collaborators--

Timeline

Phase 2CompletedFinished

2009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2008

First PostedAug 2008

Primary CompletionMay 2011

Study CompletionMay 2016

TodayJul 2026

First PostedAug 4, 2008

Enrollment StartJul 14, 2008

Primary CompletionMay 12, 2011

Study CompletionMay 25, 2016

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 17.9 years ago

Interventions

BIBW 2992drug

BIBW 2992 once daily

TMZdrug

TMZ 21/28

BIBW 2992 plus TMZdrug

BIBW 2992 once daily plus TMZ 21/28 days