Clinical Trial Details
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NCT01677741 : A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
PhasePhase 1
AgesMin: 12 Months Max: 17 Years
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

- 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

- 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.
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