BIBF 1120 in Recurrent Glioblastoma Multiforme

This study has been completed.

Sponsor:

Collaborators:

Boehringer Ingelheim Pharmaceuticals

University of Copenhagen

Information provided by (Responsible Party):

Ulrik Lassen, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01251484

First received: December 1, 2010

Last updated: October 3, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 1, 2010
Last Updated Date	October 3, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 1, 2010)	Response rate [ Time Frame: Response evaluation every 8 weeks ] [ Designated as safety issue: No ] MacDonald criteria
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01251484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 1, 2010)	Adverse events [ Time Frame: Assessed every 2 weeks ] [ Designated as safety issue: Yes ] CTCAE version 4.0
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	BIBF 1120 in Recurrent Glioblastoma Multiforme
Official Title ^ICMJE	Phase II Study of BIBF 1120 in Recurrent Glioblastoma Multiforme
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Recurrent Glioblastoma
Intervention ^ICMJE	Drug: BIBF1120 Tablet 200 mg twice daily until progression
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	August 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria 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 contraception. Fertile males must use preservatives. Exclusions criteria Prior treatment with BIBF 1120 or any other VEGFR inhibitor, except bevacizumab in Group 2 Chemo-, hormono-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug. Persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial Therapeutic anticoagulation( except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid<325mg per day Major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period History of clinically significant haemorrhagic or thromboembolic event in the past 6 months Known inherited predisposition to bleeding or thrombosis Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion) Proteinuria CTCAE grade 2 or greater Hepatic function: total bilirubin outside of normal limits; ALT or AST > 1.5 ULN Coagulation parameters: International normalised ratio ( INR) > 2, prothrombin time - (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN Absolute neutrophil count ( ANC) < 1500/ml, platelets < 100000/ml, Haemoglobin < 9.0 g/dl Other malignancies within the past 5 years other then basal cell skin cancer or carcinoma in situ of the cervix Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy Active or chronic hepatitis C and/or B infection Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study. Pregnancy or breast feeding Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule active alcohol or drug abuse
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01251484
Other Study ID Numbers ^ICMJE	BIBF1120 GBM
Has Data Monitoring Committee	Yes
Responsible Party	Ulrik Lassen, Rigshospitalet, Denmark
Study Sponsor ^ICMJE	Ulrik Lassen
Collaborators ^ICMJE	Boehringer Ingelheim Pharmaceuticals University of Copenhagen
Investigators ^ICMJE	Not Provided
Information Provided By	Rigshospitalet, Denmark
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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