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This study was terminated due to the limited enrollment.
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This is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30 evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. All subjects in this study are required to have accessible extracranial metastases and are agreeable to undergo repetitive biopsies. The first cohort of 15 subjects will receive dabrafenib orally 150mg twice daily (BID) for 7 to 14 days prior to surgery (Cohort A); the second cohort of 15 subjects will receive the combination of dabrafenib 150 mg BID and trametinib 2 mg once daily for 7 to 14 days prior to surgery (Cohort B). The primary purpose of this study is to determine levels and distribution of dabrafenib, its metabolites, and trametinib (Cohort B only) in parenchymal brain metastases, extracranial metastases, and peripheral blood (plasma) within two cohorts of subjects with BRAF V600E/K mutation-positive melanoma that has metastasized to the brain. All subjects will be followed for survival and new anti-cancer therapy for a total of two years or until death or the subject wishes to withdraw from further follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | The first cohort of 15 subjects will receive oral dabrafenib 150 mg twice daily orally for 7 to 14 days prior to surgery in Cohort A; Subjects will be treated for at least 7 days prior to craniotomy, but not more than 14 days. Subjects in either cohort with intracranial and/or extracranial metastases remaining after surgery may resume treatment with the combination of dabrafenib 150 mg BID and trametinib 2 mg once daily no earlier than 72 hours after surgery |
|
| Cohort B | Experimental | The second cohort of 15 subjects will receive dabrafenib 150 mg twice daily combined with trametinib 2 mg once daily (Cohort B) orally for 7 to 14 days prior to surgery; Subjects will be treated for at least 7 days prior to craniotomy, but not more than 14 days. Subjects in either cohort with intracranial and/or extracranial metastases remaining after surgery may resume treatment with the combination of dabrafenib 150 mg BID and trametinib 2 mg once daily no earlier than 72 hours after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabrafenib 150 mg | Drug | Dabrafenib will be provided for oral administration as 50 mg and 75 mg capsules. Dabrafenib will be dosed orally with approximately 200 mL of water, twice a day. Dabrafenib should be administered under fasting conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Peripheral Blood (Plasma) | Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib were collected on day of surgical resection of the brain metastasis(es), Two samples were collected before surgery and 2 samples after surgery with one hour gap in between. Upon collection blood was placed on wet ice. Plasma was isolated within 60 minutes of collection and frozen at -20 degree celsius. | Pre-surgery and post-surgery on Day 15 |
| Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Parenchymal Brain Metastases | Concentrations of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib, and possibly other drug-related species were quantified in the pharmacokinetic tissue sample by an investigative Liquid chromatography- mass spectrometry (LC-MS)/MS method. The spatial distribution of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib and possibly other drug-related species in the tissue samples were determined using an investigative matrix assisted laser desorption ionization (MALDI) analysis method. Parenchymal brain metastases and extracranial metastases using MALDI imaging was not determined for all participants (completed by GSK for the first two participants enrolled) | Day 15 |
| Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) and Trametinib (Cohort B Only) in CSF Samples. | Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib and trametinib (as appropriate), were planned but not collected. | Pre-surgery and post-surgery on Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) in Cerebrospinal Fluid (CSF) Samples | Concentrations of dabrafenib, its metabolites hydroxy-, carboxy- and desmethyl-dabrafenib) and trametinib in CSF (in participants who agree for optional collection of CSF at the time of brain tumor resection). Optional collection of CSF was obtained in the operating room on the day of brain metastasis resection. CSF samples for only one participant were collected and analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States | ||
| GSK Investigational Site |
Not provided
Six participants (five male and one female) with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain were enrolled into the study, all into Cohort A. There were no participants enrolled in Cohort B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Participants in Cohort A received dabrafenib orally 150 milligram twice daily for 7 to 14 days prior to surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2015 | Jan 12, 2018 |
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| Trametinib 2.0 mg | Drug | Trametinib study treatment will be provided as 0.5 mg and 2.0 mg tablets. should be taken orally with approximately 200 mL of water under fasting conditions, either one hour before or two hours after a meal. |
|
| Day 15 |
| Number of Participants With Changes in Mitogen-activated Protein Kinase (MAPK) Pathway Markers | Changes in MAPK pathway markers in paired extracranial biopsies taken pre-treatment, during craniotomy, and at disease progression, and changes in markers between post-operative intracranial and extracranial biopsies was planned but not performed as the study was terminated due to low enrollment. | Up to Day 15 |
| Number of Participants With Changes in Radiographic Tumors | Changes in the radiographic characteristics of the tumors were planned to be compared to (1) levels of dabrafenib, its metabolites and trametinib (where appropriate) in the brain metastases, plasma, and CSF, and (2) MAPK pathway activation status in tumors at the time of surgery. Results were planned to be compared to the analysis of early clinical responses in extracranial metastases, as determined by the Positron emission tomography (PET-CT) imaging. This analysis was planned but not performed as the study was terminated due to low enrollment | Up to 2 years |
| Percent Change From Baseline to Pre-surgery in the Sum of the Longest Diameters (SLD) of Intracranial Target Lesions | The change from Baseline to the pre-surgery intracranial disease assessment in the SLD of intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment. | Up to 2 years |
| Maximum Percent Change From Baseline in the SLD of Unresected Intracranial Target Lesions | The maximum change from Baseline in the SLD of unresected intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment. | Up to 2 years |
| Percentage of Participants With Overall Extracranial Response Rate in Unresected Lesions | Overall Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime as per modified Response Evaluation Criteria in Solid Tumors (RECIST). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence and is determined programmatically based on the investigator's assessment of response at each time point. Overall Extracranial Response Rate was planned but not analyzed as the study was terminated due to low enrollment. | Approximately 2 years or death whichever occurs first |
| Percentage of Participants With Overall Survival | Overall survival, defined as the time from first dose of study treatment to death for any reason, was planned to summarize using Kaplan-Meier quartile estimates along with two sided 95% confidence intervals. But were not performed as the study was terminated due to low enrollment. | Approximately 2 years or death whichever occurs first |
| Number of Participants With Abnormal Vital Signs | Vital sign measurements including temperature, respiratory rate, systolic and diastolic blood pressure, and pulse rate were planned to be performed but were neither summarized nor listed as the study was terminated. | Up to 2 years |
| Number of Participants With Abnormal Physical Examinations | A complete physical examination was planned which included assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. Height and weight was also planned to be measured and recorded. A complete physical exam including a thorough genitourinary examination for female participants, inspection of the head and neck region, and digital rectal examination for both male and female participants was planned to be performed at Screening, and Month 12 or at discontinuation if discontinuation occurs prior to Month 12. If the participants had a genitourinary and rectal exam within 6 months of screening, these assessments need not to be repeated at screening. But data for physical examinations were not summarized and listed as the study was terminated. | Up to 2 years |
| Number of Participants With Abnormal 12-lead Electrocardiograms (ECG) | 112-lead ECGs were planned to be obtained at screening during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. At each assessment a 12-lead ECG was planned to be performed by qualified personnel at the site after at least a five-minute rest with the participants in a semi-recumbent or supine position. But data for 12-lead ECGs were not summarized and listed as the study was terminated. | Screening |
| Number of Participants With Abnormal Echocardiogram (ECHO) | ECHO include an evaluation for Left ventricular ejection fraction (LVEF) and both right- and left-sided valvular lesions. ECHO was planned to be performed at screening, Week 8 and every 16 weeks till discontinuation. data for ECHO was not summarized and listed as the study was terminated. | Up to 2 years |
| Number of Participants With Abnormal Clinical Laboratory Assessments | Laboratory assessments included parameters like Hematology, Standard Chemistry, Coagulation, Serum Pregnancy. Assessment of these parameters were planned to be performed by the central laboratory on screening, Day prior to surgery, Every 4 weeks after restart and Discontinuation, but were not analyzed as the study was terminated due to low enrollment. | Up to 2 years |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE were collected from the time the first dose of study treatment is administered until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy using Medical Dictionary for Regulatory Activities (MedDRA) | Up to 2 years |
| Houston |
| Texas |
| 77030 |
| United States |
| GSK Investigational Site | North Sydney | New South Wales | 2060 | Australia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Participants in Cohort A received dabrafenib orally 150 milligram twice daily for 7 to 14 days prior to surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Peripheral Blood (Plasma) | Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib were collected on day of surgical resection of the brain metastasis(es), Two samples were collected before surgery and 2 samples after surgery with one hour gap in between. Upon collection blood was placed on wet ice. Plasma was isolated within 60 minutes of collection and frozen at -20 degree celsius. | The Pharmacokinetic analysis set included all participants who provided at least one evaluable Pharmacokinetic concentration. | Posted | Number | Nano grams per milliliter (ng/mL) | Pre-surgery and post-surgery on Day 15 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Parenchymal Brain Metastases | Concentrations of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib, and possibly other drug-related species were quantified in the pharmacokinetic tissue sample by an investigative Liquid chromatography- mass spectrometry (LC-MS)/MS method. The spatial distribution of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib and possibly other drug-related species in the tissue samples were determined using an investigative matrix assisted laser desorption ionization (MALDI) analysis method. Parenchymal brain metastases and extracranial metastases using MALDI imaging was not determined for all participants (completed by GSK for the first two participants enrolled) | Pharmacokinetic Analysis Set | Posted | Number | ng/mL | Day 15 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) and Trametinib (Cohort B Only) in CSF Samples. | Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib and trametinib (as appropriate), were planned but not collected. | Pharmacokinetic Analysis Set | Posted | Pre-surgery and post-surgery on Day 15 |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) in Cerebrospinal Fluid (CSF) Samples | Concentrations of dabrafenib, its metabolites hydroxy-, carboxy- and desmethyl-dabrafenib) and trametinib in CSF (in participants who agree for optional collection of CSF at the time of brain tumor resection). Optional collection of CSF was obtained in the operating room on the day of brain metastasis resection. CSF samples for only one participant were collected and analyzed. | Pharmacokinetic Analysis Set | Posted | Number | ng/mL | Day 15 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Changes in Mitogen-activated Protein Kinase (MAPK) Pathway Markers | Changes in MAPK pathway markers in paired extracranial biopsies taken pre-treatment, during craniotomy, and at disease progression, and changes in markers between post-operative intracranial and extracranial biopsies was planned but not performed as the study was terminated due to low enrollment. | Full Analysis Set. Analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to Day 15 |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Changes in Radiographic Tumors | Changes in the radiographic characteristics of the tumors were planned to be compared to (1) levels of dabrafenib, its metabolites and trametinib (where appropriate) in the brain metastases, plasma, and CSF, and (2) MAPK pathway activation status in tumors at the time of surgery. Results were planned to be compared to the analysis of early clinical responses in extracranial metastases, as determined by the Positron emission tomography (PET-CT) imaging. This analysis was planned but not performed as the study was terminated due to low enrollment | Full Analysis Set. Analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Pre-surgery in the Sum of the Longest Diameters (SLD) of Intracranial Target Lesions | The change from Baseline to the pre-surgery intracranial disease assessment in the SLD of intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Percent Change From Baseline in the SLD of Unresected Intracranial Target Lesions | The maximum change from Baseline in the SLD of unresected intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Extracranial Response Rate in Unresected Lesions | Overall Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime as per modified Response Evaluation Criteria in Solid Tumors (RECIST). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence and is determined programmatically based on the investigator's assessment of response at each time point. Overall Extracranial Response Rate was planned but not analyzed as the study was terminated due to low enrollment. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Approximately 2 years or death whichever occurs first |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Survival | Overall survival, defined as the time from first dose of study treatment to death for any reason, was planned to summarize using Kaplan-Meier quartile estimates along with two sided 95% confidence intervals. But were not performed as the study was terminated due to low enrollment. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Approximately 2 years or death whichever occurs first |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Vital Signs | Vital sign measurements including temperature, respiratory rate, systolic and diastolic blood pressure, and pulse rate were planned to be performed but were neither summarized nor listed as the study was terminated. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Physical Examinations | A complete physical examination was planned which included assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. Height and weight was also planned to be measured and recorded. A complete physical exam including a thorough genitourinary examination for female participants, inspection of the head and neck region, and digital rectal examination for both male and female participants was planned to be performed at Screening, and Month 12 or at discontinuation if discontinuation occurs prior to Month 12. If the participants had a genitourinary and rectal exam within 6 months of screening, these assessments need not to be repeated at screening. But data for physical examinations were not summarized and listed as the study was terminated. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal 12-lead Electrocardiograms (ECG) | 112-lead ECGs were planned to be obtained at screening during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. At each assessment a 12-lead ECG was planned to be performed by qualified personnel at the site after at least a five-minute rest with the participants in a semi-recumbent or supine position. But data for 12-lead ECGs were not summarized and listed as the study was terminated. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Screening |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Echocardiogram (ECHO) | ECHO include an evaluation for Left ventricular ejection fraction (LVEF) and both right- and left-sided valvular lesions. ECHO was planned to be performed at screening, Week 8 and every 16 weeks till discontinuation. data for ECHO was not summarized and listed as the study was terminated. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Clinical Laboratory Assessments | Laboratory assessments included parameters like Hematology, Standard Chemistry, Coagulation, Serum Pregnancy. Assessment of these parameters were planned to be performed by the central laboratory on screening, Day prior to surgery, Every 4 weeks after restart and Discontinuation, but were not analyzed as the study was terminated due to low enrollment. | Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment. | Posted | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE were collected from the time the first dose of study treatment is administered until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy using Medical Dictionary for Regulatory Activities (MedDRA) | Safety Set Population The Safety Set comprised of all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 2 years
AEs and SAEs were collected in Safety Set Population which comprised of all participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A | Participants in Cohort A received dabrafenib orally 150 milligram twice daily for 7 to 14 days prior to surgery. | 4 | 6 | 4 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Granulomatous liver disease | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2017 | Jan 12, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Participant 1, Dabrafenib, Post-Surgery 2 |
|
| Participant 1, Desmethyl-dabrafenib,Pre-Surgery 1 |
|
| Participant 1, Desmethyl-dabrafenib,Pre-Surgery 2 |
|
| Participant 1, Desmethyl-dabrafenib,Post-Surgery 1 |
|
| Participant 1, Desmethyl-dabrafenib,Post-Surgery 2 |
|
| Participant 1,Hydroxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 1,Hydroxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 1,Hydroxy-dabrafenib,Post-Surgery 1 |
|
| Participant 1,Hydroxy-dabrafenib,Post-Surgery 2 |
|
| Participant 1,carboxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 1,carboxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 1,carboxy-dabrafenib,Post-Surgery 1 |
|
| Participant 1,carboxy-dabrafenib,Post-Surgery 2 |
|
| Participant 2, Dabrafenib, Pre-Surgery 1 |
|
| Participant 2, Dabrafenib, Pre-Surgery 2 |
|
| Participant 2, Dabrafenib, Post-Surgery 1 |
|
| Participant 2, Dabrafenib, Post-Surgery 2 |
|
| Participant 2, Desmethyl-dabrafenib,Pre-Surgery 1 |
|
| Participant 2, Desmethyl-dabrafenib,Pre-Surgery 2 |
|
| Participant 2, Desmethyl-dabrafenib,Post-Surgery 1 |
|
| Participant 2, Desmethyl-dabrafenib,Post-Surgery 2 |
|
| Participant 2,Hydroxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 2,Hydroxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 2,Hydroxy-dabrafenib,Post-Surgery 1 |
|
| Participant 2,Hydroxy-dabrafenib,Post-Surgery 2 |
|
| Participant 2,carboxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 2,carboxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 2,carboxy-dabrafenib,Post-Surgery 1 |
|
| Participant 2,carboxy-dabrafenib,Post-Surgery 2 |
|
| Participant 3, Dabrafenib, Pre-Surgery 1 |
|
| Participant 3, Dabrafenib, Pre-Surgery 2 |
|
| Participant 3, Dabrafenib, Post-Surgery 1 |
|
| Participant 3, Dabrafenib, Post-Surgery 2 |
|
| Participant 3, Desmethyl-dabrafenib,Pre-Surgery 1 |
|
| Participant 3, Desmethyl-dabrafenib,Pre-Surgery 2 |
|
| Participant 3, Desmethyl-dabrafenib,Post-Surgery 1 |
|
| Participant 3, Desmethyl-dabrafenib,Post-Surgery 2 |
|
| Participant 3,Hydroxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 3,Hydroxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 3,Hydroxy-dabrafenib,Post-Surgery 1 |
|
| Participant 3,Hydroxy-dabrafenib,Post-Surgery 2 |
|
| Participant 3,carboxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 3,carboxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 3,carboxy-dabrafenib,Post-Surgery 1 |
|
| Participant 3,carboxy-dabrafenib,Post-Surgery 2 |
|
| Participant 4, Dabrafenib, Pre-Surgery 1 |
|
| Participant 4, Dabrafenib, Pre-Surgery 2 |
|
| Participant 4, Dabrafenib, Post-Surgery 1 |
|
| Participant 4, Dabrafenib, Post-Surgery 2 |
|
| Participant 4, Desmethyl-dabrafenib,Pre-Surgery 1 |
|
| Participant 4, Desmethyl-dabrafenib,Pre-Surgery 2 |
|
| Participant 4, Desmethyl-dabrafenib,Post-Surgery 1 |
|
| Participant 4, Desmethyl-dabrafenib,Post-Surgery 2 |
|
| Participant 4,Hydroxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 4,Hydroxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 4,Hydroxy-dabrafenib,Post-Surgery 1 |
|
| Participant 4,Hydroxy-dabrafenib,Post-Surgery 2 |
|
| Participant 4,carboxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 4,carboxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 4,carboxy-dabrafenib,Post-Surgery 1 |
|
| Participant 4,carboxy-dabrafenib,Post-Surgery 2 |
|
| Participant 5, Dabrafenib, Pre-Surgery 1 |
|
| Participant 5, Dabrafenib, Pre-Surgery 2 |
|
| Participant 5, Dabrafenib, Post-Surgery 1 |
|
| Participant 5, Dabrafenib, Post-Surgery 2 |
|
| Participant 5, Desmethyl-dabrafenib,Pre-Surgery 1 |
|
| Participant 5, Desmethyl-dabrafenib,Pre-Surgery 2 |
|
| Participant 5, Desmethyl-dabrafenib,Post-Surgery 1 |
|
| Participant 5, Desmethyl-dabrafenib,Post-Surgery 2 |
|
| Participant 5,Hydroxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 5,Hydroxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 5,Hydroxy-dabrafenib,Post-Surgery 1 |
|
| Participant 5,Hydroxy-dabrafenib,Post-Surgery 2 |
|
| Participant 5,carboxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 5,carboxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 5,carboxy-dabrafenib,Post-Surgery 1 |
|
| Participant 5,carboxy-dabrafenib,Post-Surgery 2 |
|
| Participant 6, Dabrafenib, Pre-Surgery 1 |
|
| Participant 6, Dabrafenib, Pre-Surgery 2 |
|
| Participant 6, Dabrafenib, Post-Surgery 1 |
|
| Participant 6, Dabrafenib, Post-Surgery 2 |
|
| Participant 6, Desmethyl-dabrafenib,Pre-Surgery 1 |
|
| Participant 6, Desmethyl-dabrafenib,Pre-Surgery 2 |
|
| Participant 6, Desmethyl-dabrafenib,Post-Surgery 1 |
|
| Participant 6, Desmethyl-dabrafenib,Post-Surgery 2 |
|
| Participant 6,Hydroxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 6,Hydroxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 6,Hydroxy-dabrafenib,Post-Surgery 1 |
|
| Participant 6,Hydroxy-dabrafenib,Post-Surgery 2 |
|
| Participant 6,carboxy-dabrafenib,Pre-Surgery 1 |
|
| Participant 6,carboxy-dabrafenib,Pre-Surgery 2 |
|
| Participant 6,carboxy-dabrafenib,Post-Surgery 1 |
|
| Participant 6,carboxy-dabrafenib,Post-Surgery 2 |
|
|
|
|