BIBF 1120 for Recurrent High-Grade Gliomas
|ClinicalTrials.gov Identifier: NCT01380782|
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Gliosarcoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma||Drug: BIBF 1120||Phase 2|
This is a two arm, multicenter, open label phase II trial in adult patients with recurrent supratentorial high-grade glioma. One arm (the "bevacizumab naïve" arm) will enroll patients who have not received prior bevacizumab therapy, and the other arm (the "post-bevacizumab" arm) will enroll patients who have experienced progression on bevacizumab.
All subjects will receive BIBF 1120 at 200mg orally, twice daily in cycles of 28 days. Subjects will come to the clinic on Day 1 of each cycle (or within 2 days prior) for blood and urine tests and a physical and neurologic exam. Bloods will also be checked within 2 days before or after Day 15 of Cycles 1 and 2. An additional blood sample will be taken on Days 1 and 8 of Cycle 1, at the start of every even-numbered cycle, and at the end of active study treatment. Subjects will have gadolinium-enhanced brain MRI scans performed with tumor measurements at screening, at the start of even-numbered cycles, and at the end of active study treatment(unless already obtained within 4 weeks of completing study treatment). 40 study subjects will have diffusion- and perfusion-weighted MRI at baseline, after 1 week on therapy (± 2 days), within 2 days prior to the start of every even-numbered cycle, and at the end of treatment (unless already obtained within 4 weeks of completing study treatment).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Triple Receptor Tyrosine Kinase Receptor Inhibitor BIBF 1120 in Recurrent High-Grade Gliomas|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2014|
Experimental: Bevacizumab Naive
Bevacizumab naive subjects
Drug: BIBF 1120
200 mg BID oral for 28 day cycle
Experimental: Prior Bevacizumab
Patients previously treated with bevacizumab
Drug: BIBF 1120
200 mg BID oral for 28 day cycle
- 6-Month Progression Free Survival [ Time Frame: Six months ]To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).
- 3-Month Progression Free Survival [ Time Frame: 3 months ]To determine the efficacy of BIBF 1120 in bevacizumab-treated participants with recurrent GBM as measured by 3-month progression free survival (PFS3).
- Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response [ Time Frame: 2 years ]Best radiographic response in both populations. There were no participants with partial or complete responses, so the results are being reported in the proportion of participants who experienced stable disease (SD) as their best response (as opposed to progressive disease).
- Overall Survival [ Time Frame: 2 years ]Overall survival in both populations
- Time-to-tumor Progression [ Time Frame: 2 years ]Time-to-tumor progression in both populations.
- Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial) [ Time Frame: 2 years ]Safety profile in both populations - as adverse events are posted separately in detail, these results will demonstrate serious adverse events (defined as grades 3-5) that were judged at least possibly related to Nintedanib (BIBF 1120).
- Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG) [ Time Frame: Arm A - 6 months; Arm B - 3 months ]To explore the efficacy of BIBF 1120 in bevacizumab-naïve and bevacizumab-treated participants with recurrent anaplastic gliomas (AG) survival was assessed at 6 months for Arm A and 3 months for Arm B.
- Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile [ Time Frame: 2 years ]To explore the extent to which the tumor's genotype and expression profile correlate with outcome.
- 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 [ Time Frame: 2 years ]To explore the correlation between serum angiogenic peptides, circulating endothelial cells, and circulating progenitor cells with response to therapy.
- Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI [ Time Frame: 2 years ]To explore the correlation between perfusion MRI, diffusion MRI and response to therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380782
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908-4324|
|Principal Investigator:||Patrick Y Wen, M.D.||Dana-Farber Cancer Institute|