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This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabrafenib plus trametinib | patients treated with dabrafenib and trametinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-investigational | Other | Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria. | Approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | Defined as time from the onset of tumor response until the date of the first documented progressive disease (PD) or death due to any cause. | Approximately 4 years |
| Clinical benefit rate (CBR) |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants diagnosed with a rare BRAF V600E mutation-positive unresectable or metastatic solid tumor, 1 year and older excluding patients with melanoma, Non-Small Cell Lung Cancer, Colorectal Cancer, Anaplastic Thyroid Cancer, Biliary Tract Cancer and glioma, who will be treated with dabrafenib and trametinib.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lundquist Inst BioMed at Harbor | Recruiting | Torrance | California | 90509-2910 | United States |
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Defined as the proportion of study participants with a best overall response of CR, PR or stable disease (SD), lasting as per independent central review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST v1.1. or other relevant response criteria.
| Approximately 4 years |
| Rocky Mountain Cancer Centers | Recruiting | Denver | Colorado | 80218 | United States |
|
| Johns Hopkins University | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
|
| Duke Clinical Research Institute | Recruiting | Durham | North Carolina | 27704 | United States |
|
| Oncology Hematology Care Inc | Recruiting | Cincinnati | Ohio | 45242 | United States |
|
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
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| El Paso Texas Oncology | Recruiting | El Paso | Texas | 79902 | United States |
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| Texas Oncology San Antonio | Recruiting | San Antonio | Texas | 78258 | United States |
|
| ID | Term |
|---|---|
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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