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NCT00727506 · ClinicalTrials.gov registry record · Phase 2
BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
NCT00727506: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00727506 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 151 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00727506, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
Study 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.
Primary Outcome
Number of Participants With Dose Limiting Toxicities (DLT) - Phase I Part
Interventions
- DRUG TMZ
- DRUG BIBW 2992
- DRUG BIBW 2992 plus TMZ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2008-07-14 |
| Est. Completion | 2016-05-25 |
| Phase | Phase 2 |
What the finished NCT00727506 record still lists
NCT00727506 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 3 interventions - of which TMZ is the first listed.
NCT00727506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00727506 about?
NCT00727506 is a clinical study titled "BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma". 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 com...
What is the current status of trial NCT00727506?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2008-07-14. Estimated completion is 2016-05-25.
What interventions are being tested in trial NCT00727506?
The interventions under investigation include: TMZ (DRUG), BIBW 2992 (DRUG), BIBW 2992 plus TMZ (DRUG).
Who is sponsoring clinical trial NCT00727506?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00727506's enrollment target sits among peer trials
151 454th of 2000 higher than 1,546 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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