Please assess the completion status of the following clinical trial:

Trial Title: A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~* Written informed consent - a signed informed consent and/or assent (as age appropriate) will be obtained according to institutional guidelines.~* Male or female \>=12 months and \<18 years of age at the time of signing the informed consent form.~* Recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease. Note: Subjects with metastatic (and surgically unresectable) melanoma can be enrolled for first-line treatment; Melanoma subjects with CNS involvement may be enrolled.~* At least one evaluable lesion.~* BRAF V600 mutation-positive tumor as confirmed in a Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory or equivalent (the local BRAF testing may be subject to subsequent verification by centralized testing; centralized testing can confirm V600E and V600K mutations only).~* Performance score of \>=50% according to the Karnofsky/Lansky performance status scale (subjects with a performance status of \<=50% can be enrolled if the subject's confinement to bed and inability to carry out activities is due solely to cancer-related pain, as assessed by the investigator).~* Females of child-bearing potential (with negative serum pregnancy test within 7 days prior to the first dose of study medication) must be willing to practice acceptable methods of birth control .~* Sexually active males, who do not agree to abstinence, must be willing to use a condom during intercourse while taking the study drug, and for 16 weeks after stopping treatment and should not father a child in this period.~* Must have adequate organ function as defined by the following values: Adequate bone marrow function defined as-absolute neutrophil count (ANC) \>=1000/ microliter (µL), hemoglobin \>=8.0 grams (g)/ deciliter (dL) (may receive red blood cell transfusions), platelets \>=75,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment).~* Adequate renal and metabolic function defined as: calculated glomerular filtration rate (eGFR) (Schwartz formula), or radioisotope GFR \>=90 milliliters/minutes (mL/min)/1.73 meter square (m\^2); or a serum creatinine within the institutional reference range upper limit of normal (for age/gender, if available).~* Adequate liver function defined as: bilirubin (sum of conjugated + unconjugated) \<=1.5 x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine transaminase (ALT) \<=2.5 x ULN; AST/ALT may be \<5 x ULN at baseline if disease under treatment involves the liver (requires radiographic confirmation of liver involvement).~* Adequate cardiac function defined as: left ventricular ejection fraction (LVEF) of either \>=50% by ECHO or greater than institutional lower limit of normal (LLN) by echocardiogram (ECHO) (while not receiving medications for cardiac function), corrected QT using Bazett's (QTcB) interval \<450 milliseconds (msecs).~Exclusion Criteria:~* Part 2 ONLY: Previous treatment with dabrafenib, another RAF inhibitor, or a mitogen-activated protein kinase (MEK) inhibitor (exception: prior treatment with sorafenib is permitted).~* Malignancy OTHER than the BRAF mutant malignancy under study.~* Had chemotherapy or radiotherapy within 3 weeks (or 6 weeks for nitrosoureas or mitomycin C) prior to administration of the first dose of study treatment.~* The subject has received an investigational product within the following time period prior to the first dosing day in the current study: 28 days or 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is warranted by the data).~* History of another malignancy. Exception: (a) Subjects who have been successfully treated and are disease-free for 3 years, (b) a history of completely resected non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in stable remission are eligible.~* Current use of a prohibited medication or herbal preparation or requires any of these medications during the study.~* Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Grade 2 or higher from previous anti-cancer therapy, including major surgery except those that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profile of dabrafenib (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid based chemotherapy).~* Has leukaemia.~* History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib and its excipients.~* Autologous or allogeneic stem cell transplant within 3 months prior to enrolment \[NOTE: subjects with evidence of active graph versus host disease are excluded\].~* History of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation.~* Subjects with abnormal cardiac valve morphology (\>=grade 2) documented by echocardiogram (NOTE: subjects with grade 1 abnormalities \[i.e., mild regurgitation/stenosis\] can be entered on study).~* Subjects with moderate valvular thickening.~* Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks~* Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.~* Presence of active GI disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.~* Hepatitis B Virus, or Hepatitis C Virus infection (subjects with laboratory evidence of Hepatitis B Virus clearance may be enrolled).~* Pregnant females as determined by positive human chorionic gonadotropin (hCG) test at screening or prior to dosing.~* Lactating females who are actively breast feeding.

- Gender: ALL
- Minimum Age: 12 Months
- Maximum Age: 17 Years
- Healthy Volunteers: f

Study Arms:
- Part 1: Dabrafenib treatment (Type: EXPERIMENTAL): Three subjects will receive a single dose of 3 mg/kg dabrafenib on Day 1 and repeat dose will begin from Day 2, evenly divided in two daily doses. Once all 3 subjects have been fully evaluated for the first 28 days (including Day 15 PK) and no DLTs are observed, a next subject will be enrolled at the next higher dose levels (i.e., dose escalation to 3.75 mg/kg \[+1\] and may be further to 4.5 mg/kg \[+2\] and so on). If all 3 subjects have not been fully evaluated for the first 28 days or 1 DLT occurred, the fourth subject will be enrolled at the same dose level. If 2 or more DLTs are observed, the next subject will be enrolled at the next lower dose level (i.e., de-escalated to 2.25 mg/kg \[-1\] and may be further to 1.5 mg/kg \[-2\]). Similarly, the process is repeated for the fifth and sixth subjects in a cohort. All subjects will receive treatment till end of study.
- Part 2: Cohort 1 Low-Grade Gliomas with BRAF V600 mutations (Type: EXPERIMENTAL): Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
- Part 2: Cohort 2 High-Grade Gliomas with BRAF V600 mutations (Type: EXPERIMENTAL): Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
- Part 2: Cohort 3 LCH with BRAF V600 mutations (Type: EXPERIMENTAL): Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
- Part 2: Cohort 4 Melanoma and PTC with BRAF V600 mutations (Type: EXPERIMENTAL): Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete