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Keep this study
Lead
University Hospital Tuebingen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent must be obtained prior to performing any study-related procedures
Male or female patients ≥ 18 years of age
Patients with histologically confirmed metastatic melanoma (Stage III unresectable or Stage IV; American Joint Committee on Cancer, 7thEdition) with documented BRAF V600 mutation prior to first administration of dabrafenib or vemurafenib
Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 0.5 cm in the brain MRI with contrast
ECOG performance status of 0 to 2
Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
Adequate hematologic, renal, and liver function tests, as defined by the following laboratory values, performed within 7 days prior to first administration of dabrafenib or vemurafenib:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 9 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN) or creatine clearance (CrCl) \> 50 mL/min by Cockcroft-Gault formula
* Aspartate aminotransferase (AST \[SGOT\]) and alanine aminotransferase (ALT \[SGPT\]) ≤ 2.5 times ULN
* Serum bilirubin ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if considered due to liver metastases)
* LVEF ≥ institutional LLN by ECHO
Negative serum pregnancy test within 14 days prior to first administration of dabrafenib or vemurafenib in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year
Fertile women must use a highly effective method of contraception during treatment and for at least 1 month after completion of treatment, as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e., \< 1% per year) when used consistently and correctly Hormonal-based methods (e.g., oral contraceptives) are not permitted due to potential drug-drug interactions with dabrafenib. See also "Pregnancy Testing and Prevention", page39. At the discretion of the investigator, acceptable methods of contraception may include total abstinence, in cases where the lifestyle of the patient ensures compliance. Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception
Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before trial entry
Patients must be able to swallow tablets
You may not be if
Treatment with other UV sensitizing compounds such as psoralens, phenothiazine, tetracycline, amiodarone, phytopharmacons
UV treatment within the last 3 months
Previous treatment with a BRAF and/or MEK inhibitor.
Cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of an investigational anti-cancer drug within 28 days preceding the first dose of dabrafenib or vemurafenib
Current use of a prohibited medication or requires any of these medications during treatment with dabrafenib or vemurafenib
Current use of therapeutic warfarin NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted
Unresolved toxicity of National Cancer Institute Common (NCI) Terminology Criteria for Adverse Events, v 4.0, ( Grade 2 or higher from previous anti-cancer therapy, except alopecia
Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs
A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection
Known immediate or delayed hypersensitivity reaction to Vemurafenib or Dabrafenib or excipients
Presence of non-cutaneous malignancies other than metastatic melanoma (Stage IV) within 5 years of study enrollment or any malignancy with confirmed activating RAS mutation
Brain metastases that are symptomatic and/or requiring corticosteroids. Subjects on a stable dose of corticosteroids \>1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for \>4 weeks
Corrected QT (QTc) interval \>450 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; abnormal cardiac valve morphology (≥ grade 2) documented by echocardiogram (subjects with minimal abnormalities \[i.e., mild regurgitation/stenosis\] can be entered on study with approval from the coordinating Investigator; or history of known cardiac arrhythmias
Uncontrolled dysfunction of the electrolyte metabolism
Known Long-QT-syndrome or intake of drugs which prolong the QT interval
Uncontrolled medical conditions (i.e., diabetes mellitus, hypertension, etc.), 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
Patients with extensive tattoos that would restrict skin surface available for phototesting or obscure skin reactions
Pregnant or lactating females
Clareo Health | Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study
