We are analyzing https://link.springer.com/article/10.1007/s10637-017-0502-8.

Title:
Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAF V600 mutation-positive solid tumors: a phase 1 study | Investigational New Drugs
Description:
Background Dabrafenib is a BRAF inhibitor that has demonstrated clinical activity with a good tolerability profile in patients with BRAF V600E mutated metastatic melanoma. This study evaluated the safety and tolerability, pharmacokinetics and preliminary efficacy of dabrafenib in Japanese patients. Methods This phase I, open-label, dose escalation study was conducted in 12 Japanese patients with BRAF V600 mutation positive solid tumours. Primary endpoint was safety, assessed by monitoring and recording of all adverse events (AEs), serious AEs, drug-related AEs; secondary endpoints were pharmacokinetic profiles and efficacy measured by tumour response. This study is registered with ClinicalTrials.gov, number NCT01582997. Results Of the 12 patients enrolled, 3 each received 75 mg and 100 mg dabrafenib while 6 received 150 mg dabrafenib twice daily orally. Melanoma and thyroid cancer were the primary tumours reported in 11 (92%) and 1 (8%) patients respectively. Most AEs were grade 1 or 2 and considered related to study treatment. Most common AEs reported in the 12 patients were alopecia in 7 (58%); pyrexia, arthralgia and leukopenia in 6 (50%) each, hyperkeratosis and nausea in 4 (33%) each. Partial response as best overall response was reported in 7 of 12 (58%) patients and in 6 (55%) with malignant melanoma. No dose-limiting toxicity (DLTs) were reported during the DLT evaluation periods. Conclusions Dabrafenib was well tolerated and rapidly absorbed administered as single- or multiple dose. Comparable safety and pharmacokinetic profiles were observed compared with non-Japanese patients. Dabrafenib has promising clinical activity in Japanese patients with BRAF mutated malignant melanoma.
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pubmed, article, braf, google, scholar, cas, melanoma, patients, dabrafenib, central, study, cancer, mutation, phase, metastatic, japanese, med, novartis, personal, chugai, zhang, clinical, mutations, reports, bristolmyers, squibb, ono, safety, solid, fujiwara, inhibitor, access, advanced, engl, doinejmoa, flaherty, trial, kefford, long, japan, fees, privacy, cookies, content, research, yamazaki, aes, thyroid, papillary, sosman,

Topics {✒️}

month download article/chapter braf v600 mutation trametinib combination therapy high-risk clinicopathological features mitogen-activated protein kinases depressed-type colorectal neoplasias braf-mutated metastatic melanoma drug-related aes braf inhibitor therapy braf v600 mutations braf v600e mutation full article pdf yutaka fujiwara braf mutation assessment article fujiwara braf mutation status braf-mutant melanoma fujiwara reports grants privacy choices/manage cookies solid tumors malignant melanoma good tolerability profile ascierto pa solid tumours article investigational pharmacokinetic profiles phase ii trial related subjects nokihara reports grants braf inhibitor dabrafenib braf mutation mek inhibitor toxicities author correspondence article log pharmacokinetic profile dose-limiting toxicity dlt evaluation periods rapidly absorbed administered hairy-cell leukemia powerful prognostic factor kane-carson ls burris ha 3rd geukes foppen mh broad target blockade krishna swetha gummuluri medical writing support full access ethics declarations conflict bristol-myers squibb independent ethics committee

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Puxeddu E, Filetti S (2014) BRAF mutation assessment in papillary thyroid cancer: are we ready to use it in clinical practice?

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         headline:Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAF V600 mutation-positive solid tumors: a phase 1 study
         description: Background Dabrafenib is a BRAF inhibitor that has demonstrated clinical activity with a good tolerability profile in patients with BRAF V600E mutated metastatic melanoma. This study evaluated the safety and tolerability, pharmacokinetics and preliminary efficacy of dabrafenib in Japanese patients. Methods This phase I, open-label, dose escalation study was conducted in 12 Japanese patients with BRAF V600 mutation positive solid tumours. Primary endpoint was safety, assessed by monitoring and recording of all adverse events (AEs), serious AEs, drug-related AEs; secondary endpoints were pharmacokinetic profiles and efficacy measured by tumour response. This study is registered with ClinicalTrials.gov, number NCT01582997. Results Of the 12 patients enrolled, 3 each received 75 mg and 100 mg dabrafenib while 6 received 150 mg dabrafenib twice daily orally. Melanoma and thyroid cancer were the primary tumours reported in 11 (92%) and 1 (8%) patients respectively. Most AEs were grade 1 or 2 and considered related to study treatment. Most common AEs reported in the 12 patients were alopecia in 7 (58%); pyrexia, arthralgia and leukopenia in 6 (50%) each, hyperkeratosis and nausea in 4 (33%) each. Partial response as best overall response was reported in 7 of 12 (58%) patients and in 6 (55%) with malignant melanoma. No dose-limiting toxicity (DLTs) were reported during the DLT evaluation periods. Conclusions Dabrafenib was well tolerated and rapidly absorbed administered as single- or multiple dose. Comparable safety and pharmacokinetic profiles were observed compared with non-Japanese patients. Dabrafenib has promising clinical activity in Japanese patients with BRAF mutated malignant melanoma.
         datePublished:2017-09-07T00:00:00Z
         dateModified:2017-09-07T00:00:00Z
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            Japanese
            Malignant melanoma
            Mutation
            Solid tumor
            Oncology
            Pharmacology/Toxicology
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      headline:Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAF V600 mutation-positive solid tumors: a phase 1 study
      description: Background Dabrafenib is a BRAF inhibitor that has demonstrated clinical activity with a good tolerability profile in patients with BRAF V600E mutated metastatic melanoma. This study evaluated the safety and tolerability, pharmacokinetics and preliminary efficacy of dabrafenib in Japanese patients. Methods This phase I, open-label, dose escalation study was conducted in 12 Japanese patients with BRAF V600 mutation positive solid tumours. Primary endpoint was safety, assessed by monitoring and recording of all adverse events (AEs), serious AEs, drug-related AEs; secondary endpoints were pharmacokinetic profiles and efficacy measured by tumour response. This study is registered with ClinicalTrials.gov, number NCT01582997. Results Of the 12 patients enrolled, 3 each received 75 mg and 100 mg dabrafenib while 6 received 150 mg dabrafenib twice daily orally. Melanoma and thyroid cancer were the primary tumours reported in 11 (92%) and 1 (8%) patients respectively. Most AEs were grade 1 or 2 and considered related to study treatment. Most common AEs reported in the 12 patients were alopecia in 7 (58%); pyrexia, arthralgia and leukopenia in 6 (50%) each, hyperkeratosis and nausea in 4 (33%) each. Partial response as best overall response was reported in 7 of 12 (58%) patients and in 6 (55%) with malignant melanoma. No dose-limiting toxicity (DLTs) were reported during the DLT evaluation periods. Conclusions Dabrafenib was well tolerated and rapidly absorbed administered as single- or multiple dose. Comparable safety and pharmacokinetic profiles were observed compared with non-Japanese patients. Dabrafenib has promising clinical activity in Japanese patients with BRAF mutated malignant melanoma.
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      dateModified:2017-09-07T00:00:00Z
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          BRAF V600
         Dabrafenib
         Japanese
         Malignant melanoma
         Mutation
         Solid tumor
         Oncology
         Pharmacology/Toxicology
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      name:Dermatology Division, Shizuoka Cancer Center Hospital, Shizuoka, Japan
      name:Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan
      name:Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan
      name:Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan
      name:Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan
      name:Development Department, Novartis Pharma K.K, Tokyo, Japan
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      name:Thoracic Center, St. Luke’s International Hospital, Tokyo, Japan
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