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Recurrent GlioblastomaPhase 2NCT01251484

BIBF 1120 in Recurrent Glioblastoma Multiforme

A Phase 2 study testing BIBF1120 in people with Recurrent Glioblastoma, run by Ulrik Lassen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
BIBF1120
Type of treatment
Pill or oral medicine
How many people
25 participants
Where
1 siteDenmark
Study dates
Jan 2011to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 40Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Phase II Study of BIBF 1120 in Recurrent Glioblastoma Multiforme

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.

Being tested
BIBF1120
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIBF1120Drug

    Tablet 200 mg twice daily until progression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    MacDonald criteria

    Measured: Response evaluation every 8 weeks

Secondary outcomes (1)

  1. Adverse events

    CTCAE version 4.0

    Measured: Assessed every 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01251484
Sponsor's protocol ID
BIBF1120 GBM
Status last verified
Oct 2012
First submitted
1 Dec 2010
Last updated
4 Oct 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBF1120 in people with Recurrent Glioblastoma, run by Ulrik Lassen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Response evaluation every 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01251484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.

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