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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 151 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00727506
The ClinicalTrials.gov registry entry for NCT00727506 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which TMZ is the first listed.
NCT00727506 reports 0 study locations.
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.
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