Clinical Trials Logo

Clinical Trial Summary

This pilot clinical trial studies dabrafenib and trametinib in treating patients with ameloblastoma and a specific mutation (change) in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To observe the response rate of ameloblastoma to dabrafenib and trametinib at 6 weeks. SECONDARY OBJECTIVES: I. Feasibility and safety in this patient population. II. Response will be assessed pathologically. III. Two main histologic assays for treatment response will be used: tumor necrosis and phosphorylated-mitogen-activated protein kinase kinase 1 (MEK), phosphorylated-extracellular signal-regulated kinase (ERK), and Ki-67 levels as measured by immunohistochemistry. OUTLINE: Patients receive dabrafenib orally (PO) twice daily (BID) every 12 hours and trametinib 2 mg daily PO for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease is judged to be not amenable to resection will continue dabrafenib and trametinib indefinitely as long as there has not been tumor progression. After completion of study treatment, patients are followed up for at least 4 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02367859
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase Phase 2
Start date July 17, 2017
Completion date June 26, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06287463 - Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway Phase 1/Phase 2
Active, not recruiting NCT03049618 - Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475 Phase 2
Active, not recruiting NCT03088176 - Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma Phase 1
Withdrawn NCT03972046 - Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma Phase 2
Recruiting NCT04903119 - Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma Phase 1
Completed NCT03750175 - OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -
Terminated NCT04488003 - Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations Phase 2
Recruiting NCT04238624 - Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer Phase 2
Completed NCT01531361 - Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations Phase 1
Recruiting NCT06270082 - Study of IK-595 in RAS- or RAF-altered Advanced Tumors Phase 1
Completed NCT03784378 - Continued Access to RXDX-105 Phase 1
Terminated NCT01907802 - Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction Phase 1
Active, not recruiting NCT02925689 - Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction Phase 1
Completed NCT01700582 - French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings
Recruiting NCT05786924 - A Study of BDTX-4933 in Patients With KRAS, BRAF and Select RAS/MAPK Mutation-Positive Cancers Phase 1
Recruiting NCT06449989 - Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Colorectal Cancer
Available NCT04566393 - Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies