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Tyrosine Kinase Inhibitor

Bevacizumab Naive for Gliomas

Phase 2
Waitlist Available
Led By Patrick Y Wen, M.D.
Research Sponsored by Patrick Y. Wen, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

BIBF 1120 is a newly discovered compound that may stop cancer cells from growing abnormally. This drug is currently being used in treatment for other cancers in research studies and information from those other research studies suggests that this agent, BIBF 1120, may help to stop recurrent malignant glioma cells from multiplying and it may also prevent the growth of new blood vessels at the site of the tumor. In this research study, the investigators are looking to see how well BIBF 1120 works in patients with recurrent malignant gliomas.

Eligible Conditions
  • Gliomas
  • Solid Tumors
  • Brain Tumor
  • Glioblastoma
  • Gliosarcoma
  • Oligodendroglioma
  • Anaplastic Astrocytoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
3-Month Progression Free Survival
6-Month Progression Free Survival
Secondary study objectives
Overall Survival
Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response
Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial)
+1 more
Other study objectives
Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG)
Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile
Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells
+1 more

Side effects data

From 2013 Phase 3 trial • 551 Patients • NCT01335477
63%
Diarrhoea
26%
Nausea
15%
Nasopharyngitis
13%
Decreased appetite
12%
Cough
11%
Weight decreased
10%
Vomiting
9%
Abdominal pain
9%
Upper respiratory tract infection
8%
Fatigue
8%
Bronchitis
8%
Dyspnoea
7%
Idiopathic pulmonary fibrosis
7%
Headache
6%
Constipation
6%
Back pain
5%
Abdominal pain upper
5%
Respiratory tract infection
5%
Pneumonia
3%
Hypertension
2%
Arthralgia
2%
Pulmonary hypertension
1%
Transaminases increased
1%
Cerebral infarction
1%
Acute myocardial infarction
1%
Aortic valve stenosis
1%
Cardiac failure
1%
Myocardial infarction
1%
Haemorrhoids
1%
Rib fracture
1%
Intervertebral disc protrusion
1%
Pulmonary embolism
1%
Respiratory failure
1%
Atypical pneumonia
1%
Hypoxia
1%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nintedanib 150mg Bid

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prior BevacizumabExperimental Treatment1 Intervention
Patients previously treated with bevacizumab
Group II: Bevacizumab NaiveExperimental Treatment1 Intervention
Bevacizumab naive subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
FDA approved

Find a Location

Who is running the clinical trial?

The Cleveland ClinicOTHER
1,053 Previous Clinical Trials
1,371,137 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,018 Previous Clinical Trials
13,309,708 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,550 Previous Clinical Trials
15,857,469 Total Patients Enrolled
~3 spots leftby Nov 2025
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