BIBF 1120 in Recurrent Glioblastoma Multiforme
Phase II Study of BIBF 1120 in Recurrent Glioblastoma Multiforme
1 other identifier
interventional
25
1 country
1
Brief Summary
VEGF inhibition by BEV may induce a change in tumor invasiveness and treatment failure is often associated with remote metastases. BEV may stop the growth of tumor cells by blocking blood flow to the tumor. Cediranib, a pan-VEGF inhibitor has shown promising results in recurrent GBM. VEGF-blocking with small molecules may overcome the mechanism of resistance, and response to BIBF-1120 in such circumstances may open a new treatment option in GBM. In additional, recurrent glioblastomas have an extremely poor prognosis, so innovative therapies are needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedOctober 4, 2012
October 1, 2012
1.6 years
December 1, 2010
October 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate
MacDonald criteria
Response evaluation every 8 weeks
Secondary Outcomes (1)
Adverse events
Assessed every 2 weeks
Interventions
Tablet 200 mg twice daily until progression
Eligibility Criteria
You may qualify if:
- Written informed consent
- Histological verification of primary GBM and failure after radiotherapy and TMZ
- \- Previously received radiotherapy and TMZ
- More than 4 weeks since any of the following prior treatments
- Chemotherapy (6 weeks for nitrosureas or mitomycin C)
- Radiotherapy to nontarget lesions or lesions that are not to be biopsied
- Investigational agents
- More than 6 months since prior major surgery or open biopsy and recovered (only 6 weeks required if operation is for recurrent BGM)
- ● ECOG performance status 0-1
- Age \> 18 years
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Fertile females must use anticonception (p- pills, IUD, depot injection of gestagen, subdermal
- implantation, hormonal vaginal ring or transdermal depot plaster, throughout the study and 3
- months after discontinuation of study drugs. Fertile men must use dobbelt barrier method
- (preservative with sperm inhibiting creme) or female partner uses the above mentioned
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulrik Lassenlead
- Boehringer Ingelheimcollaborator
- University of Copenhagencollaborator
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ulrik Lassen, MD, PH.D
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 2, 2010
Study Start
January 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 4, 2012
Record last verified: 2012-10