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BIBF 1120 in Recurrent Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01251484
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ulrik Lassen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Completed
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rigshospitalet, Copenhagen, Denmark

Status

Address

Rigshospitalet

Copenhagen, , 2100