Phase II Pediatric Study With Dabrafenib in Combination With Trametinib in Patients With HGG and LGG
Status: | Recruiting |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any - 17 |
Updated: | 3/13/2019 |
Start Date: | December 28, 2017 |
End Date: | September 13, 2024 |
Contact: | Novartis Pharmaceuticals |
Email: | novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)
The purpose of this study is to investigate the activity of dabrafenib in combination with
trametinib in children and adolescent patients with BRAF V600 mutation positive low grade
glioma or relapsed or refractory high grade glioma.
trametinib in children and adolescent patients with BRAF V600 mutation positive low grade
glioma or relapsed or refractory high grade glioma.
Inclusion Criteria:
- Diagnosis of BRAF V600 mutant High Grade glioma that has relapsed, progressed or
failed to respond to frontline therapy
- Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following
surgical excision, or non-surgical candidates with necessity to begin first systemic
treatment because of a risk of neurological impairment with progression.
- Confirmed measurable disease
Exclusion Criteria:
- Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK
inhibitor
- HGG patient: Cancer treatment within the past 3 weeks. LGG patient: Any systemic
therapy or radiotherapy prior to enrollment
- LGG patients: history of allergic reaction or contraindications to the use of
carboplatin or vincristine
- Stem cell transplant within the past 3 months
- History of heart disease
- Pregnant or lactating females
We found this trial at
15
sites
225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Stewart Goldman
Phone: 312-227-4811
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Santhosh Upadhyaya
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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1201 W La Veta Ave
Orange, California 92868
Orange, California 92868
(714) 997-3000
Principal Investigator: Ashley Plant
Phone: 714-509-4348
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Lindsey Hoffman
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Baltimore, Maryland 21287
Principal Investigator: Kenneth Cohen
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Karen W. Wright
Phone: 617-632-3352
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Cincinnati, Ohio 45229
Principal Investigator: Trent Hummel
Phone: 513-803-1140
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Dallas, Texas 75235
Principal Investigator: Theodore Laetsch
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1102 Bates Avenue
Houston, Texas 77030
Houston, Texas 77030
Principal Investigator: Patricia A Baxter
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Michael Ferguson
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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2401 Gillham Road
Kansas city, Missouri 64108
Kansas city, Missouri 64108
Principal Investigator: Kevin Ginn
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New York, New York 10021
Principal Investigator: Stephen Gilheeney
Phone: 646-888-5722
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Principal Investigator: Karen Gauvain
Phone: 314-454-4962
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Washington, District of Columbia 20010
Principal Investigator: Roger Packer
Phone: 202-884-2120
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