AN OPEN-LABEL, DOSE-ESCALATION, PHASE I/II STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND CLINICAL ACTIVITY OF THE MEK INHIBITOR TRAMETINIB IN CHILDREN AND ADOLESCENTS SUBJECTS WITH CANCER OR PLEXIFORM NEUROFIBROMAS AND TRAMETINIB IN COMBINATION WITH DABRAFENIB IN CHILDREN AND ADOLESCENTS WITH CANCERS HARBORING V600 MUTATIONS

Registry ID

CTMT212X2101 (MEK116540)

Source registry

HEALTH_CANADA

Status

Closed

Phase

PHASE1

Study type

INTERVENTIONAL

Sponsor

NOVARTIS PHARMACEUTICALS CANADA INC

Start date

2020-07-27

Completion date

2020-12-29

Last update

2014-06-23

Conditions

• BRAF MUTATION-POSITIVE TUMORS
• PLEXIFORM NEUROFIBROMAS

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• A PHASE 2 STUDY OF TRAMETINIB FOR PATIENTS WITH PEDIATRIC GLIOMA OR PLEXIFORM NEUROFIBROMA WITH REFRACTORY TUMOR AND ACTIVATION OF THE MAPK/ERK PATHWAY
• PHASE II STUDY OF IMATINIB MESYLATE (PMS) IN NEUROFIBROMATOSIS TYPE I PATIENTS AGED 2 TO 21 WITH PLEXIFORM NEUROFIBROMAS
• A PHASE 1 AND PHARMACOKINETIC STUDY OF DABRAFENIB (GSK2118436B) IN PATIENTS WITH BRAFV600X MUTATIONS AND RENAL OR HEPATIC DYSFUNCTION.

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