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Tafinlar Medical Research Studies

Up-to-date List of Tafinlar Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Tafinlar Medical Research Studies

Rank Status Study
1 Recruiting Dabrafenib, Trametinib, and Navitoclax in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
Conditions: Adult Solid Neoplasm;   Recurrent Melanoma;   Stage IIIA Skin Melanoma;   Stage IIIB Skin Melanoma;   Stage IIIC Skin Melanoma;   Stage IV Skin Melanoma
Interventions: Drug: Dabrafenib;   Other: Laboratory Biomarker Analysis;   Biological: Navitoclax;   Other: Pharmacological Study;   Drug: Trametinib
Outcome Measures: Maximal degree of tumor regression (Phase II);   Proportion of patients with a CR, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, in the cohort of patients treated with dabrafenib, trametinib, and navitoclax (DTN) (Phase II);   Recommended phase II dose of the combination of dabrafenib, trametinib, and navitoclax determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (Phase I);   ORR (Phase II);   OS (Phase II);   PFS (Phase II)
2 Recruiting A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
Condition: Neoplasms, Brain
Intervention: Drug: Dabrafenib
Outcome Measures: Safety and tolerability of dabrafenib dose that achieves similar exposures to the dabrafenib adult dose as assessed by number of subjects with adverse events (AEs);   Safety and tolerability of dabrafenib dose that achieves similar exposures to the dabrafenib adult dose as assessed by change from Baseline in ECG readings;   Safety and tolerability of dabrafenib dose that achieves similar exposures to the dabrafenib adult dose as assessed by change from Baseline in ECHO findings;   Safety and tolerability of dabrafenib dose that achieves similar exposures to the dabrafenib adult dose as assessed by change from Baseline in laboratory values;   Safety and tolerability of dabrafenib dose that achieves similar exposures to the dabrafenib adult dose as assessed by change from Baseline in vital signs;   Maximum concentration (Cmax) of dabrafenib dose(s);   Area under the concentration-time curve over the dosing interval (AUC(0-τ)) and AUC from zero to infinity (AUC(0-inf)) of dabrafenib dose(s);   Pre-dose (trough) concentration (C tau) of dabrafenib and its metabolites;   The AUC(0-t) and AUC(0-tau) of dabrafenib and its metabolites;   Apparent clearance following oral dosing (CL/F) of dabrafenib;   Cmax of dabrafenib, and its metabolites;   Time from administration to Cmax (tmax) of dabrafenib and its metabolites;   Elimination half life (t½) of dabrafenib and its metabolites;   Longer term safety and tolerability of dabrafenib as assessed by number of subjects with AEs;   Longer term safety and tolerability of dabrafenib as assessed by change from Baseline in ECG readings;   Longer term safety and tolerability of dabrafenib as assessed by change from Baseline in laboratory values;   Longer term safety and tolerability of dabrafenib as assessed by change from Baseline in vital signs;   Overall tumor response of dabrafenib;   Effect of age and weight on CL/F of dabrafenib;   Effect of age and weight on volume of distribution (V/F) of dabrafenib;   Effect of age and weight on absorption rate (ka) of dabrafenib;   Effect of age and weight on coefficients for significant covariates of dabrafenib
3 Recruiting Dabrafenib and Lapatinib Ditosylate in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery
Condition: Recurrent Thyroid Gland Carcinoma
Interventions: Drug: Dabrafenib;   Other: Laboratory Biomarker Analysis;   Drug: Lapatinib Ditosylate;   Other: Pharmacological Study
Outcome Measures: Maximum tolerated dose of lapatinib ditosylate, in combination with the established dose of dabrafenib, defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity;   Mean percent change in the post-treatment tissues relative to pre-treatment tissues for the phosphorylated protein targets examined;   Mean percentage change in transcript levels in the post-treatment tissues relative to pre-treatment tissues for several genes analyzed by reverse-transcriptase-polymerase chain reaction
4 Recruiting Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction
Conditions: Adult Solid Neoplasm;   Hepatic Complication;   Renal Failure
Interventions: Drug: Dabrafenib;   Other: Laboratory Biomarker Analysis;   Other: Pharmacological Study
Outcome Measures: Incidence of toxicities graded according to NCI CTCAE v4.0;   MTD of dabrafenib, defined as the highest dose level that is estimated to induce a dose-limiting toxicity rate less than 33.3% by the two-way isotonic regression, graded according to NCI CTCAE v4.0;   Best response, defined as the best objective status recorded from the start of treatment until disease progression/recurrence, measured by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria;   Incidence of adverse events graded according to NCI CTCAE v4.0;   Time to progression;   Time to treatment failure;   Time until any treatment-related toxicity;   Time until hematologic nadirs (white blood cells, ANC, platelets);   Time until treatment related grade 3+ toxicity
5 Recruiting Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma
Condition: Solid Tumours
Interventions: Drug: Dabrafenib;   Drug: Trametinib;   Drug: Ipilimumab
Outcome Measures: Number of subjects with Adverse Events (AEs) to assess the safety of dabrafenib +/- trametinib when administered in combination with ipilimumab;   Changes in laboratory values, vital signs, and physical examinations as a measure of safety of dabrafenib +/- trametinib when administered in combination with ipilimumab;   Number of subjects with AEs and changes in laboratory values, vital signs, and physical examinations to determine a recommended dose for dabrafenib +/- trametinib when administered in combination with ipilimumab;   Overall response rate;   Concentrations of trametinib, dabrafenib and its metabolites (GSK2285403, GSK2298683, and GSK2167542) in the triplet arm and dabrafenib and its metabolites in the doublet arm
6 Recruiting A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors
Condition: Cancer
Interventions: Drug: Dabrafenib 150 mg  twice a day (BID);   Drug: Rabeprazole 40 mg once daily (OD);   Drug: Rifampin 600 mg OD
Outcome Measures: PK assessment (Cmax) of Dabrafenib with and without Rabeprazole or Rifampin;   PK assessment (tmax) of Dabrafenib with and without Rabeprazole or Rifampin;   PK assessment (AUC[0-tau]) of Dabrafenib with and without Rabeprazole or Rifampin;   PK assessment of Dabrafenib co administered with rabeprazole or rifampin;   PK assessment (AUC[0-tau]) of hydroxy-dabrafenib, carboxy-dabrafenib, and desmethyl-dabrafenib;   PK assessment (Cmax and Ctau,) of hydroxy-dabrafenib, carboxy-dabrafenib, and desmethyl-dabrafenib;   PK assessment (tmax) of hydroxy-dabrafenib, carboxy-dabrafenib, and desmethyl-dabrafenib;   Ratio of metabolite to Dabrafenib;   Safety and tolerability assessment to measure vital signs;   Safety and tolerability assessment for 12-lead ECG;   Safety and tolerability assessment for laboratory tests;   Safety and tolerability assessment of dabrafenib in combination with rabeprazole or rifampin;   Concentrations of Rabeprazole in the presence of Dabrafenib;   Concentrations of Rifampin in the presence of Dabrafenib
7 Recruiting Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites
Condition: Melanoma and Brain Metastases
Interventions: Drug: Dabrafenib 150 mg;   Drug: Trametinib 2.0 mg
Outcome Measures: Concentrations of dabrafenib, its metabolites hydroxy-, carboxy- and desmethyl-dabrafenib and trametinib (Cohort B only) in parenchymal brain metastases, extracranial metastases, and peripheral blood (plasma);   Tissue distribution of dabrafenib, its metabolites hydroxy-, carboxy- and desmethyl-dabrafenib and trametinib (Cohort B only) in parenchymal brain metastases, extracranial metastases, and peripheral blood (plasma);   Concentrations of dabrafenib, its metabolites hydroxy-, carboxy- and desmethyl-dabrafenib) and trametinib (Cohort B only) in CSF samples.;   Changes in MAPK pathway markers;   Comparison of radiographic tumor changes;   Overall extracranial response rate in unresected lesions;   Overall Survival;   Safety and tolerability as assessed by vital signs;   Safety and tolerability as assessed by physical examinations;   Safety as assessed by 12-lead ECG;   Safety and tolerability as assessed by ECHO;   Safety and tolerability as assessed by abnormal clinical laboratory assessments;   Safety and tolerability as assessed by nature and frequency of AEs;   Change from baseline to pre-surgery in the sum of the longest diameters (SLD) of intracranial target lesions;   Maximum change from baseline in the sum of longest diameters of unresected intracranial target lesions
8 Recruiting Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma
Condition: Melanoma
Interventions: Drug: Dabrafenib;   Drug: Trametinib
Outcome Measures: The proportion of viable melanoma tissue, compared to baseline, in dissected lymph node and / or in-transit tumour tissue after 12 weeks of neoadjuvant treatment.;   Correlation of a range of tumour biomarkers at baseline, early treatment and 12 week intervals with pathological and clinical response.;   Effects of neoadjuvant study treatment on surgical outcomes after complete lymph node and / or in-transit disease dissection.;   Effects of study treatment on host immune response in tumour tissue and peripheral blood.;   Correlation of pyrexia episodes and signs with baseline melanoma disease burden (number and size of lymph nodes), RECIST response, pathological response, immune related changes in tumour tissue and peripheral blood.;   Description of specific blood and serum changes that occur with pyrexia.;   Relapse free survival;   Overall survival;   Description of adverse events and how these correlate with clinical outcomes;   The clinical response to 12 weeks neoadjuvant treatment;   Correlation of a range of tumour biomarkers at baseline, early treatment and 12 week intervals with pathological and clinical response
9 Not yet recruiting Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With Melanoma
Condition: Melanoma
Interventions: Drug: Dabrafenib;   Drug: Trametinib
Outcome Measures: Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose: Cmax,Tmax and AUC(0-tau);   A Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose : Tmax, Css_min, Css_max, Css_av and AUC(0-tau);   Accumulation ratio of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose;   Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose: Cmax, Tmax, AUC(0-tau);   Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose : Tmax, Css_min, Css_max, Css_av, AUC(0-tau);   Accumulation ratio of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose;   Composite of PK parameters of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose: Cmax, Tmax, AUC(0-tau);   Composite of PK parameters of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose : Tmax, Css_min, Css_max, Css_av, AUC(0-tau);   Accumulation ratio of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose;   Effective half-life of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose;   Physical examination assessment;   Safety and tolerability as assessed by composite of vital signs assessment: blood pressure, temperature and pulse rate;   Electrocardiogram (ECG) assessment;   Echocardiogram (ECHO) assessment;   Eye exams assessment;   Chemistry and hematology laboratory values assessment;   Number of subjects with Adverse events (AEs);   Number of subjects with Serious Adverse events (SAEs);   Objective response rate (ORR);   Progression free survival(PFS);   Overall survival(OS)
10 Recruiting Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer
Conditions: Follicular Thyroid Cancer;   Insular Thyroid Cancer;   Papillary Thyroid Cancer;   Recurrent Thyroid Cancer
Interventions: Drug: dabrafenib;   Drug: trametinib;   Other: Correlative Studies
Outcome Measures: Overall objective response rate, defined as the proportion of patients who have a minor response (MR), partial response (PR), or complete response(CR)assessed according to RECIST.;   Portion of patients with progression-free survival (PFS);   Overall survival;   Number of patients with Adverse events of GSK2118436 (BRAFi) as a single agent and adverse events of GSK2118436 (BRAFi) and GSK1120212 (MEKi) in combination.;   Tolerability of the regimens in terms of the number of patients who required dose modifications and/or dose delays.
11 Recruiting Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAF Mutant Melanoma That Cannot Be Removed by Surgery
Conditions: Recurrent Melanoma;   Stage IIIA Skin Melanoma;   Stage IIIB Skin Melanoma;   Stage IIIC Skin Melanoma;   Stage IV Skin Melanoma
Interventions: Drug: Dabrafenib;   Other: Laboratory Biomarker Analysis;   Drug: Trametinib
Outcome Measures: Superiority of intermittent dosing of dabrafenib and trametinib compared to continuous dosing with these two same agents based on progression-free survival;   Overall survival;   Rates of fever;   Response rates
12 Not yet recruiting Dabrafenib in Treating Patients With BRAF Mutated Ameloblastoma
Conditions: Ameloblastoma;   BRAF Gene Mutation
Interventions: Drug: Dabrafenib;   Other: Laboratory Biomarker Analysis
Outcome Measures: Response rate according to RECIST version (v)1.1;   Percent tumor necrosis;   Change in percent proliferation index by Ki67 immunohistochemistry;   Change in expression of phosphorylation of MEK and ERK by immunohistochemistry
13 Recruiting GSK2141795, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer
Conditions: Adult Solid Neoplasm;   Recurrent Colon Carcinoma;   Recurrent Melanoma;   Recurrent Ovarian Carcinoma;   Recurrent Ovarian Germ Cell Tumor;   Stage IIIC Colon Cancer;   Stage IIIC Ovarian Cancer;   Stage IIIC Ovarian Germ Cell Tumor;   Stage IIIC Skin Melanoma;   Stage IV Skin Melanoma
Interventions: Drug: Akt Inhibitor GSK2141795;   Drug: Dabrafenib;   Other: Laboratory Biomarker Analysis;   Other: Pharmacological Study;   Drug: Trametinib
Outcome Measures: Maximum-tolerated dose (MTD) of Akt inhibitor GSK2141795, determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I);   Objective response rate (confirmed and unconfirmed, complete and partial responses) as assessed by RECIST version 1.1 (Phase II);   Overall survival (Phase II);   Progression-free survival as assessed by RECIST version 1.1 (Phase II);   Toxicity rate graded by the NCI CTCAE version 4.0 (Phase II)
14 Recruiting Combi-Neo Study for Stage IIIB-C and Oligometastatic Stage IV Melanoma
Conditions: Melanoma;   Malignant Melanoma Stage IV;   Metastatic Melanoma
Interventions: Drug: Dabrafenib;   Drug: Trametinib;   Procedure: Surgery
Outcome Measure: One-year Relapse-Free Survival Rate
15 Recruiting Ipilimumab With or Without Dabrafenib, and/or Trametinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery
Conditions: Recurrent Melanoma;   Stage IIIA Skin Melanoma;   Stage IIIB Skin Melanoma;   Stage IIIC Skin Melanoma;   Stage IV Skin Melanoma
Interventions: Drug: Dabrafenib;   Biological: Ipilimumab;   Other: Laboratory Biomarker Analysis;   Drug: Trametinib
Outcome Measures: Proportion of patients with grade 3 or higher immune-related adverse events (irAEs), graded according to the National Cancer Institute (NCI) CTCAE v4.0;   Disease-control rate;   Proportion of patients receiving dabrafenib and trametinib with grade 3 or higher irAEs after disease progression on ipilimumab, according to the NCI CTCAE v4.0;   Response rate for the total treatment period according to Response Evaluation Criteria in Solid Tumors v1.1
16 Recruiting Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.
Condition: Cancer
Interventions: Drug: Dabrafenib;   Device: Trametinib
Outcome Measures: Overall response rate (ORR).;   Progression free survival (PFS).;   Duration of response.;   Overall survival.;   Number of subjects with adverse events as a measure of safety and tolerability;   Composite of PK parameters for Dabrafenib;   Safety as assessed by physical examination;   Safety as assessed by dermatological examination;   Safety as assessed by ophthalmic examination;   Safety as assessed by vital signs;   Safety as assessed by Single 12-lead ECG;   Safety as assessed by echocardiography (ECHO);   Safety as assessed by clinical laboratory assessments
17 Recruiting Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study
Condition: Metastatic Melanoma (Carrying BRAF V600 Mutation)
Interventions: Drug: Dabrafenib;   Drug: Vemurafenib
Outcome Measures: Degree of Solar Dermatitis due to Standardized UV Exposure in Patients treated with Dabrafenib;   Degree of Solar Dermatitis due to Standardized UV Exposure in Patients treated with Dabrafenib or Vemurafenib;   Number of Participants with Adverse Events treated with dabrafenib;   Best overall response rates and progression free survival in patients treated with dabrafenib or vemurafenib using RECIST v1.1 criteria
18 Recruiting Phase II Biomarker Study Comparing the Combination of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus the Combination After Monotherapy With Dabrafenib or Trametinib
Condition: Melanoma
Interventions: Drug: Dabrafenib;   Drug: Trametinib
Outcome Measures: Percentage Change of ERK phosphorylation score from Baseline.;   Evaluation of the overall response rate (ORR);   Characterisation of the safety profile of dabrafenib and trametinib in monotherapy with vital signs and physical examinations;   Characterisation of the safety profile of dabrafenib and trametinib in monotherapy with Eastern Cooperative Oncology Group (ECOG) performance status;   Characterisation of the safety profile of dabrafenib and trametinib in monotherapy with 12-lead electrocardiograms (ECG);   Characterisation of the safety profile of dabrafenib and trametinib in monotherapy with echocardiograms (ECHO);   Characterisation of the safety profile of dabrafenib and trametinib in monotherapy with chemistry and haematology laboratory values;   Characterisation of the safety profile of dabrafenib and trametinib in monotherapy with incidence of squamous cell carcinoma (SCC) and keratoacanthoma (KA);   Characterisation of the safety profile of dabrafenib and trametinib in monotherapy with adverse events (AEs) graded according to the Common Terminology Criteria for Adverse Events (CTC-AE), version 4.0Characterisation of the safety profile of dabrafenib;   PK analyses of dabrafenib, trametinib, and metabolites of dabrafenib in connection to clinical response (Pharmacodynamics) and toxicity
19 Recruiting LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations
Conditions: Stage III Melanoma;   Stage IV Melanoma;   Unresectable Melanoma;   BRAF Mutant Melanoma
Intervention: Drug: BRAF inhibitor dabrafenib and MEK inhibitor trametinib
Outcome Measures: Kinase Expression;   BRAF and MEK inhibition associated with new functional mutations in the approximately 150 oncogenes;   Kinome signature predictive of resistance;   Overall Response Rate  (ORR);   Duration of Overall Response Rate (ORR);   Progression Free Survival (PFS);   Rate of Overall Survival (OS)
20 Recruiting Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 E/K Mutation-Positive Acral Lentiginous Melanoma
Condition: Cancer
Interventions: Drug: Dabrafenib;   Drug: Trametinib
Outcome Measures: Objective Response Rate (ORR);   To evaluate the antitumor activity by assessing the progression-free survival (PFS);   To evaluate the antitumor activity by assessing the duration of response;   To evaluate the antitumor activity by assessing the overall survival (OS);   To assess single dose (Chinese subjects only) and steady state (all subjects) exposures to dabrafenib, dabrafenib metabolites, and trametinib, and characterize the population pharmacokinetics of dabrafenib and trametinib;   Safety and Tolerability of dabrafenib and trametinib as assessed by Physical examinations;   Safety and Tolerability of dabrafenib and trametinib as assessed by vital signs;   Safety and Tolerability of dabrafenib and trametinib as assessed by 12-lead electrocardiograms (ECG), echocardiogram (ECHO);   Safety and Tolerability of dabrafenib and trametinib as assessed by eye examinations;   Safety and Tolerability of dabrafenib and trametinib by laboratory assessments;   Safety and Tolerability of dabrafenib and trametinib as assessed adverse events (AEs)

These studies may lead to new treatments and are adding insight into Tafinlar etiology and treatment.

A major focus of Tafinlar research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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