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History of Changes for Study: NCT02684058
Phase II Pediatric Study With Dabrafenib in HGG Patients
Latest version (submitted August 10, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 11, 2016 None (earliest Version on record)
2 March 9, 2016 Study Status and Contacts/Locations
3 September 9, 2016 Study Status and Contacts/Locations
4 January 12, 2017 Study Status
5 February 13, 2017 Study Status and Oversight
6 April 21, 2017 Study Status, IPDSharing and Contacts/Locations
7 May 9, 2017 Study Status and Study Design
8 May 27, 2017 Study Status, Contacts/Locations and Oversight
9 June 9, 2017 Outcome Measures, Arms and Interventions, Study Status, Study Identification, Eligibility and Study Description
10 June 13, 2017 Arms and Interventions and Study Status
11 July 5, 2017 Study Status
12 September 26, 2017 Study Status
13 October 10, 2017 Study Status
14 January 24, 2018 Recruitment Status, Study Status and Contacts/Locations
15 March 1, 2018 Outcome Measures, Arms and Interventions, Conditions, Study Status, Study Identification, Contacts/Locations, Eligibility, Study Design, Study Description and Oversight
16 March 8, 2018 Contacts/Locations, Study Status, Outcome Measures, Study Design and Eligibility
17 May 24, 2018 Contacts/Locations and Study Status
18 June 13, 2018 Study Status and Contacts/Locations
19 June 28, 2018 Contacts/Locations and Study Status
20 August 6, 2018 Study Status and Contacts/Locations
21 August 13, 2018 Eligibility, Outcome Measures and Study Status
22 September 5, 2018 Contacts/Locations and Study Status
23 October 11, 2018 Study Status and Contacts/Locations
24 October 19, 2018 Contacts/Locations and Study Status
25 October 21, 2018 Contacts/Locations and Study Status
26 October 31, 2018 Contacts/Locations and Study Status
27 December 4, 2018 Contacts/Locations and Study Status
28 January 4, 2019 Study Status and Contacts/Locations
29 January 18, 2019 Contacts/Locations and Study Status
30 January 21, 2019 Contacts/Locations and Study Status
31 February 24, 2019 Contacts/Locations and Study Status
32 March 7, 2019 Contacts/Locations and Study Status
33 April 8, 2019 Contacts/Locations and Study Status
34 April 23, 2019 Contacts/Locations and Study Status
35 May 14, 2019 Contacts/Locations and Study Status
36 June 28, 2019 Contacts/Locations, Study Status and Eligibility
37 July 9, 2019 Contacts/Locations and Study Status
38 July 17, 2019 Contacts/Locations and Study Status
39 July 19, 2019 Contacts/Locations and Study Status
40 July 29, 2019 Contacts/Locations and Study Status
41 July 30, 2019 Contacts/Locations and Study Status
42 July 31, 2019 Contacts/Locations and Study Status
43 September 16, 2019 Contacts/Locations and Study Status
44 December 16, 2019 Contacts/Locations and Study Status
45 January 9, 2020 Contacts/Locations and Study Status
46 January 13, 2020 Contacts/Locations and Study Status
47 January 28, 2020 Study Status and Contacts/Locations
48 January 30, 2020 Contacts/Locations and Study Status
49 April 14, 2020 Contacts/Locations and Study Status
50 September 21, 2020 Contacts/Locations and Study Status
51 October 15, 2020 Contacts/Locations and Study Status
52 February 25, 2021 Study Status and Contacts/Locations
53 April 7, 2021 Recruitment Status, Contacts/Locations, Study Status and Study Design
54 May 5, 2021 Study Status
55 September 10, 2021 Contacts/Locations and Study Status
56 November 2, 2021 Contacts/Locations and Study Status
57 December 3, 2021 Study Status
58 January 27, 2022 Study Status, Contacts/Locations and Study Design
59 March 2, 2022 Study Status
60 August 10, 2022 Study Status, Study Design and IPDSharing
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Study NCT02684058
Submitted Date:  February 11, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDRB436G2201
Brief Title: Phase II Pediatric Study With Dabrafenib in HGG Patients
Official Title: Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib Treatment in Children and Adolescent Patients With BRAF V600 Mutation Positive Relapsed or Refractory High Grade Glioma (HGG)
Secondary IDs: 2015-004015-20 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2016
Overall Status: Not yet recruiting
Study Start: May 2016
Primary Completion: November 2019 [Anticipated]
Study Completion: November 2019 [Anticipated]
First Submitted: February 4, 2016
First Submitted that
Met QC Criteria:
February 11, 2016
First Posted: February 17, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 11, 2016
Last Update Posted: February 17, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to investigate the activity of dabrafenib in children and adolescent patients with BRAF V600 mutation positive relapsed or refractory high grade glioma.
Detailed Description:
Open or close this module Conditions
Conditions: Anaplastic Astrocytoma
Glioblastoma
Giant Cell Glioblastoma
Gliosarcoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Anaplastic Ependymoma
Choroid Plexus Carcinoma
Anaplastic Ganglioglioma
Pineal Parenchymal Tumor
Pineoblastoma
Medulloblastoma
PNET
Rhabdoid Tumor
Perineurioma
MPNST
Malignant Meningloma
Anaplastic Hemangiopericytoma
Keywords: Glioma
Anaplastic astrocytoma
Glioblastoma
Giant cell glioblastoma
Gliosarcoma
Anaplastic oligodendroglioma
Anaplastic oligoastrocytoma
Anaplastic ependymoma
Choroid plexus carcinoma
Anaplastic ganglioglioma
Pineal parenchymal tumor
Pineoblastoma
Medulloblastoma
PNET
Rhabdoid tumor
Perineurioma
MPNST
Malignant meningloma
Anaplastic hemangiopericytoma
Dabrafenib
Pediatrics
Brain neoplasma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: dabrafenib
Patient dose based on weight and age. Patients will receive study drug until they are no longer receiving clinical benefit as determined by investigator, disease progression, death, unacceptable toxicity, start of new anticancer treatment or study is terminated by Sponsor.
Drug: dabrafenib
dabrafenib oral, twice daily. Patient dose based on weight and age. Patients will receive study drug until they are no longer receiving clinical benefit as determined by investigator, disease progression, death, unacceptable toxicity, start of new anticancer treatment or study is terminated by Sponsor.
Other Names:
  • DRB436
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall response rate (ORR)
[ Time Frame: Within the first 4 months of treatment ]

ORR as determined by local assessment based on Magnetic resonance imaging MRI) or CT (CAT) scans using Response Assessment in Neuro-Oncology Criteria (RANO) criteria.
Secondary Outcome Measures:
1. Overall response rate (ORR)
[ Time Frame: Within the first 4 months of treatment ]

ORR as determined by central assessment based on Magnetic resonance imaging (MRI) or CT (CAT)scans using Response Assessment in Neuro-Oncology (RANO criteria)
2. Duration of response (DOR)
[ Time Frame: Within the first year of treatment ]

DOR as determined by local and central assessment based on MRI or CT scans using RANO criteria
3. Progression free survival (PFS)
[ Time Frame: Within the first year of treatment ]

PFS as determined by local and central assessment based on MRI or CT scans using RANO criteria
4. Overall survival (OS)
[ Time Frame: 2 years from last patient dosed ]

OS as defined as the time from first dose to death due to any cause
5. Overall response (OR)
[ Time Frame: Within 4 months of treatment ]

OR as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation and measurable disease
6. Duration of response (DOR)
[ Time Frame: Within 4 months of treatment ]

DOR as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation and measurable disease
7. Progression-free survival (PFS)
[ Time Frame: Within 4 months of treatment ]

PFS as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation and measurable disease
8. Overall survival (OS)
[ Time Frame: Within 4 months of treatment ]

OS as determined by central assessment based on MRI or CT scans using RANO criteria in patients with centrally confirmed HGG, BRAF V600 mutation
9. Area under the curve (AUClast)
[ Time Frame: Within the first month of treatment ]

Assessed from time zero to the last measurable sampling time
10. Area under the curve (AUCtau)
[ Time Frame: Within the first month of treatment ]

Calculated to the end of a dosing interval at steady state (12 hours)
11. Maximum Plasma Concentration (Cmax)
[ Time Frame: Within the first month of treatment ]

The maximum (peak) observed plasma drug concentration after a single dose
12. Time to reach maximum concentration (Tmax)
[ Time Frame: Within the first month of treatment ]

The time to reach maximum (peak) concentration of study drug after a single dose
13. Elimination half-life (T1/2)
[ Time Frame: Within the first month of treatment ]

The elimination half-life associated with the terminal slope of a semi-log concentration-time curve
14. Predose plasma concentration (Ctrough)
[ Time Frame: Within the first month of treatment ]

Measured concentration at the end of a dosing interval at steady state, taken directly before next study drug administration).
Open or close this module Eligibility
Minimum Age: 6 Years
Maximum Age: 17 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Diagnosis of High Grade glioma
  • Relapsed, progressed or failed to respond to frontline therapy.
  • Able to swallow capsules

Exclusion Criteria:

  • Previous treatment with dabrafenib
  • Cancer treatment within the past 3 weeks
  • Stem cell transplant within the past 3 months
  • History of heart disease
  • Pregnant or lactating females
Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: +41613241111
Central Contact Backup: Novartis Pharmaceuticals
Study Officials: Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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