Antineoplastic Agents

All Drugs and Chemicals

Dabrafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

GSK2118436 (3 capsules of 75 mg) will be administered orally at the dose of 225 mg BID from Day 1 to 7 (and single dose on Day 8) under fasted conditions, either 1 hour before or 2 hours after a meal.

GSK2118436 (4 capsules of 75 mg) will be administered orally at the dose of 300 mg BID from Day 1 to 7 (and single dose on Day 8) under fasted conditions, either 1 hour before or 2 hours after a meal. If 225 mg BID is not tolerated in Part 1 /Cohort 1, then Part 1/Cohort 2 will not be initiated and 150 mg BID will be used in Part 2.

Subjects will receive a single dose of GSK2118436/placebo (4 capsules of 75 mg/highest tolerated dose) orally on the first 2 days of the study followed by 2 doses daily for 6 days and a single dose on the 9th day. There will be 1 day when a placebo will be given. All doses will be administered under fasted conditions, either 1 hour before or 2 hours after a meal.

Each capsule contains 75 mg of GSK2118436A as the mesylate salt, micronized particles as active equivalents.

GSK2118436 75 mg

Matching placebo capsules will be administered in Part 2 of the study.

Placebo

GSK Clinical Trials

This is a Phase I, multicenter, 2-part study with Part 1 designed as a safety lead-in and Part 2 designed to evaluate the effect of GSK2118436 on cardiac repolarization (corrected QT interval \[QTc\] duration) as compared with placebo in subjects with V600 BRAF mutation-positive tumors.

Each part of the study will consist of screening (14 days prior to the start of the study treatment), treatment and follow-up period (14 days).

In Part 1 in Cohort 1 six subjects will receive GSK2118436 225 mg twice a day (BID) on study days 1 to 7 and a single 225 milligram (mg) dose on morning of Day 8. Based on the safety data of subjects in Cohort 1 subjects will be enrolled in Cohort 2 and the dose of GSK2118436 will be escalated to 300 mg BID. If the 225 mg dose of GSK2118436 is not well tolerated in Cohort 1 (i.e., 2 or more dose-limiting toxicities \[DLTs\]), then Cohort 2 of Part 1 will not be initiated and a dose of 150 mg BID of GSK2118436 will be administered in Part 2 of the study. In Cohort 2 six subjects will receive GSK2118436 300 mg BID on Study Days 1 to 7 and a single 300 mg dose on the morning of Day 8. Based on the safety data of subjects in Cohort 2 subjects will be enrolled in Part 2. If the 300 mg BID dose level of GSK2118436 is not well tolerated, then the highest tolerated dose will be selected for Part 2 of the study.

In Part 1 of the study the decision to proceed to the next cohort or Part 2 of the study will be based on the safety data of at least 6 evaluable subjects (\<=1 DLTs during the 14 days following the first dose of GSK2118436).

In Part 2 of the study eligible subjects will receive a single dose of GSK2118436/placebo (4 capsules of 75 mg/highest tolerated dose) orally on the first 2 days of the study followed by 2 doses daily for 6 days and a single dose on the 9th day. There will be 1 day when a placebo will be given.

In both the parts of the study serial blood samples for pharmacokinetic (PK) analysis for GSK2118436 and its metabolites (GSK2285403, GSK2298683 and GSK2167542) will be obtained at the same time points on the first and last day of dosing (2nd day of dosing also included for Part 2). Safety electrocardiogram (ECG)s will be performed at several timepoints during the study. In Part 2 Holter ECG monitoring will be performed for 24 hours on the 1st, 2nd and 9th days of dosing.

A Study to Evaluate the Effect of Repeat Oral Dosing of GSK2118436 on Cardiac Repolarization in Subjects With V600 BRAF Mutation-Positive Tumors

A Two-Part Study to Evaluate the Effect of Repeat Oral Dosing of GSK2118436 on Cardiac Repolarization in Subjects With V600 BRAF Mutation-Positive Tumors: An Open-label, Dose-escalating Safety Lead-in Study Followed by a Single-sequence, Placebo-controlled, Single-blind Study

Safety and tolerability parameter will include a complete (head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen \[liver and spleen\], lymph nodes, extremities, height and weight) and brief (skin, lungs, cardiovascular system, abdomen \[liver and spleen\] and weight) physical examination at Baseline and at the end of Part 1 of the study.

Safety and tolerability parameter will include measurement of vital signs (recording of systolic and diastolic blood pressure, temperature, and pulse rate) at Baseline and at the end of Part 1 of the study.

Safety and tolerability parameter will include ECGs readings (heart rate and measurement of RR, PR, QRS, QT, and QTc intervals) at Baseline and at the end of Part 1 of the study.

Safety and tolerability parameter will include laboratory values (hematology, clinical chemistry, coagulation, liver function tests, cardiac enzyme and beta-hCG/serum or urine pregnancy test for female subjects of childbearing potential only) at Baseline and at end of Part 1 of the study.

Change from Baseline in QTcF interval at each time point for GSK2118436 will be calculated as average of 3 Holter ECG replicates per time point minus the value at Baseline.

Plasma concentrations of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542 will be recorded.

Pharmacokinetic data will include area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t)) of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

Pharmacokinetic data will include maximum plasma concentration (Cmax) of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

Pharmacokinetic data will include predose concentration (Ctrough) of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

Pharmacokinetic data will include time of occurrence of Cmax (tmax) of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

The relationship between plasma concentrations of GSK2118436 and its metabolites (GSK2285403, GSK2298683 and GSK2167542) and the baseline-adjusted, placebo-corrected, time-matched change from Baseline in QTc intervals will be assessed.

ECG parameters: QT, QTcB, QTci, HR, RR interval, PR interval, QRS interval and morphology will be assessed in subjects receiving GSK2118436.

The plasma concentration of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542 will be measured.

Pharmacokinetic data will include AUC from time zero (pre-dose) to 10 hours after the last dose of study treatment (AUC(0-10)) and AUC(0 t) of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

Pharmacokinetic data will include AUC from time zero to infinity AUC(0-infinity) of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542 on Study Day 1, if data permit).

Pharmacokinetic data will include elimination half life (t1/2) of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542 if data permits.

Pharmacokinetic data will include C trough of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

Pharmacokinetic data will include Cmax of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

Pharmacokinetic data will include tmax of GSK2118436 and its metabolites GSK2285403, GSK2298683 and GSK2167542.

Safety parameters will include recording of AEs, in Part 2 of the study.

Safety parameters will include measurement of vital signs (recording of systolic and diastolic blood pressure, temperature, and pulse rate) at Baseline and at the end of Part 2 of the study.

Safety parameters will include ECGs readings (heart rate and measurement of RR, PR, QRS, QT, and QTc intervals) at Baseline and at the end of Part 2 of the study.

Safety parameters will include laboratory values (hematology, clinical chemistry, coagulation, liver function tests, cardiac enzyme and beta-hCG/serum or urine pregnancy test for female subjects of childbearing potential only) at Baseline and at end of Part 2 of the study.

GlaxoSmithKline

Anti-Infective Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Group 1: Participant was on antibiotics anytime during the past 2 weeks prior to the time of enrollment.

Tongue assessment, stool sample, and questionnaires done at baseline and once during Days 3-7 and once during Days 8-12.

Participants wear a Holter monitor for 20-24 hours at baseline and once during Days 3-7 and once during Days 8-12.

Participants given 2 tablespoons (33 cc) of yogurt each day for 12 days.

Group 2: Participant has not been on antibiotics in the past 2 weeks.

Tongue assessment, stool sample, and questionnaires done at baseline and once during Days 3-7 and once during Days 8-12.

Participants wear a Holter monitor for 20-24 hours at baseline and once during Days 3-7 and once during Days 8-12.

Participants given 2 tablespoons (33 cc) of yogurt each day for 12 days.

The coating on the top of the tongue assessed and categorized into three categories: no coating, thin coating and thick coating. The coating of the tongue may be related to the microorganisms in the intestine.

Tongue Assessment

Stool sample collected at baseline and once during Days 3-7 and once during Days 8-12.

Stool Sample

Participants complete 4 questionnaires about symptoms in the past 24 hours, irritable bowel syndrome (IBS), most recent stool, and quality-of-life. Questionnaires completed at baseline and once during Days 3-7 and once during Days 8-12. Questionnaires should take about 30 minutes total to complete.

Questionnaires

Participants wear a Holter monitor for 20-24 hours to check nervous system and heart function at baseline and once during Days 3-7 and once during Days 8-12.

Holter Monitor

Participants given 2 tablespoons (33 cc) of DannonÒ OikosÒ yogurt each day for 12 days.

Yogurt

An T. Ngo-Huang

The goal of this clinical research study is to learn if probiotics found in yogurt can help to decrease gastrointestinal (GI) symptoms in cancer patients. Probiotics are live bacteria and yeast that help with many of our functions and may help digestive problems. Researchers also want to learn if the bacteria in your stool change as your symptoms change while eating yogurt.

Baseline Tests:

If you agree to take part in this study, you will have the following tests and procedures when you enroll:

* The coating on your tongue will be checked. Researchers think that the thickness of the coating on your tongue may be related to the microorganisms in your stomach and/or intestines.
* A stool sample will be collected for bacteria testing.
* You will be asked about your diet and how often you eat yogurt.
* You will wear a monitoring device called a Holter monitor for 20-24 hours to check your nervous system and heart function.
* You will be asked to complete 4 questionnaires about your symptoms in the past 24 hours, your irritable bowel syndrome (IBS), your most recent stool, and your quality-of-life. These questionnaires should take about 30 minutes total to complete.

Study Procedures:

One (1) time during Days 3-7 and 1 time during Days 8-12:

* You will be asked to complete the same 4 questionnaires you completed at baseline.
* A stool sample will be collected by your bedside nurse for bacteria testing.
* You may wear a Holter monitor to check your heart function.

You will be given at least 2 tablespoons (33 cc) of DannonÒ OikosÒyogurt each day.

Length of Study:

Your participation in this study will be over after you complete the study procedures during Days 8 to 12.

If you are discharged before you complete the study procedures above, you will be called and asked about your symptoms and given a stool collection kit. This phone call should take about 30 minutes to complete. The study staff will give you more information about stool collection. Your sample will be collected for bacteria testing at your next clinic visit.

This is an investigational study. The use of probiotics in yogurt to treat GI symptoms in cancer patients is investigational. The study doctor can explain how the probiotics are designed to work.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms

Adherence rate calculated as percentage of times that a participant takes at least 2 table spoon (30 cc) of yogurt/day consumed for the 10±2 day prescription, as well as for the first 5±2 days, and will be summarized for each group using descriptive statistics. Regimen considered feasible for each group if at least 70% of participants in that group have reached at least 70% adherence rate in 10±2 days.

M.D. Anderson Cancer Center

Amino Acids

Lapatinib

Tyrosine Kinase Inhibitors

Tyrosine

This is a crossover study where subjects will receive placebo that mimics lapatinib for 2 days and lapatinib for 2 days. Subjects will not know when they are receiving placebo vs. lapatinib.

lapatinib commercial tablet, 2000mg, will be given as three separate doses (8 tablets/dose) given 12 hours apart over a 2 day period

lapatinib

placebo matching lapatinib will be given as three separate doses (8 tablets/dose) given 12 hours apart over a 2 day period

placebo matching lapatinib

This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval duration) in subjects with advanced solid tumors. The study treatment period will occur over five days and an End of Study visit will be conducted on Day 8 (or no later than 3 days beyond Day 8). Subjects will receive placebo that mimics lapatinib for 2 days as three separate doses given 12 hours apart (8 tablets/dose) and lapatinib (2000mg) for 2 days as three separate doses given 12 hours apart (8 tablets/dose). Subjects will not know when they are receiving placebo vs. lapatinib. Digital 12-lead ECG recordings will be extracted from continuous ECG recordings obtained via a Holter monitor to measure QTc interval duration. Triplicate ECG measurements of QTc interval will be taken at pre-specified times at Day 1 (Baseline) and pre-dose and up to 24 hours after the third dose of placebo or lapatinib on Study Days 2 and 4. Pharmacokinetic sampling will occur immediately following each pre-specified QTc measurement in subjects dosed with placebo or lapatinib. Subjects who complete participation in this study, if they are eligible, will be offered the option to continue treatment with lapatinib, either alone or in combination with other oncology drugs in pre-selected anticancer regimens, in a continuation protocol, EGF111767.

A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval

A Phase IV, Placebo-controlled Single Sequence Crossover Study to Evaluate the Effect of Repeat Oral Doses of Lapatinib on Cardiac Repolarization in Patients With Advanced Cancer

A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and on Day 3 for LAP. Mean change from BL was calculated by subtracting the BL values from individual QTcF for each TP. BL adjusted mean difference in absolute QTcF between LAB and PBO (trt difference) with the corresponding 90% confidence interval (CI) was estimated for each TP (pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, and 24-hr post-dose). Trt difference analysis was performed by a repeated measures analysis of variance adjusted for trt group, TP, and trt group\*TP interaction.

A Holter monitor is an ambulatory portable device for continuously monitoring the cardiovascular system. Change from Baseline in QT interval, QTc interval, QTcB interval, QTcI interval, RR interval, PR interval, and QRS duration at each time point for lapatinib was assessed in comparison with time-matched placebo. Three replicate ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 and 3 and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the average of the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. Change from Baseline was calculated by subtracting the Baseline values from individual post-Baseline values for each time point.

The number of participants with 12-lead Holter ECG findings of normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate 12-lead Holter ECGs were collected at -30, -15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10,12, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and on Day 3 for lapatinib.

Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate Holter ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. The number of participants with the worst-case post-Baseline 12-lead Holter ECG findings with significant ST, T wave, and U wave abnormalities were analyzed.

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, or is an important medical eventsthat jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, new primary cancers, liver events, cardiac dysfunction, pneumonitis, and laboratory abnormalities.

Blood samples were collected for the measurement of albumin and hemoglobin at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.

Blood samples were collected for the measurement of ALP, ALT, and AST at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.

Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at Baseline; Days 5 and 8-11; Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.

Blood samples were collected for the measurement of calcium, chloride, CO2, potassium, sodium, magnesium and urea at Baseline; at Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.

Blood samples were collected for the measurement of total neutrophils (ANC), platelets, and leukocyte count at Baseline; Days 5 and 8-11. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.

Blood pressure measurements included SBP and DBP and were obtained at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose). Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Heart rate were measured at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

The number of participants with the 12-lead ECG findings normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Baseline; on Day 1 (at pre-dose); on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-last- dose); on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-last-dose); at the End of Study visit (Day 8-11); and at the post-treatment Follow-up visit (if applicable).

AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-t) and AUC(0-24) were determined from the plasma concentration-time data using the linear trapezoidal rule for increased concentrations and the logarithmic trapezoidal rule for decreased concentrations. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.

The first occurrence of Cmax and C24 was determined directly from the raw concentration-time data. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.

For each participant, the time at which Cmax was observed (tmax) was determined directly from the raw concentration-time data. For each participant, the time prior to the first quantifiable (non-zero) concentration (tlag) was determined directly from the raw concentration-time data. Since all participants received 2 doses of study medication prior to the collection of the first (pre-dose) blood sample on Day 4, tlag was expected to be zero. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.

The number of participants in 1st Period - placebo (57) is different from 2nd Period - lapatinib (58) because one participant was "double dosed" with lapatinib (i.e., received lapatinib during both the 1st period and 2nd period) due to dosing error.

Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.

Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.

Lapatinib 2000 mg

Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.

Placebo and Lapatinib 2000 mg

Age, Continuous

Sex: Female, Male

African American/African Heritage

Asian - East Asian Heritage

Asian - South East Asian Heritage

White - White/Caucasian/European Heritage

missing

Race/Ethnicity, Customized

GSK Response Center

Pre-dose

1 hour

2 hour

3 hour

4 hour

6 hour

8 hour

10 hour

12 hour

24 hour

Evaluable Population: all participants in the All-Treated Subjects (ATS) Population who met the criteria for dosing compliance, ECG acquisition, and Baseline ECG acquisition. The ATS Population is comprised of all participants who received at least one dose of study medication (placebo or lapatinib).

Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg

QT interval (predose), n=37, 37

QT interval (1 hour), n=37, 37

QT interval (2 hour), n=37, 37

QT interval (3 hour), n=37, 37

QT interval (4 hour), n=37, 37

QT interval (6 hour), n=37, 36

QT interval (8 hour), n=37, 36

QT interval (10 hour), n=37, 37

QT interval (12 hour), n=37, 37

QT interval (24 hour), n=37, 35

QTcI interval (predose), n=37, 37

QTcI interval (1 hour), n=37, 37

QTcI interval (2 hour), n=37, 37

QTcI interval (3 hour), n=37, 37

QTcI interval (4 hour), n=37, 37

QTcI interval (6 hour), n=37, 36

QTcI interval (8 hour), n=37, 36

QTcI interval (10 hour), n=37, 37

QTcI interval (12 hour), n=37, 37

QTcI interval (24 hour), n=37, 35

QTcB interval (predose), n=37, 37

QTc B interval (1 hour), n=37, 37

QTcB interval (2 hour), n=37, 37

QTcB interval (3 hour), n=37, 37

QTcB interval (4 hour), n=37, 37

QTcB interval (6 hour), n=37, 36

QTcB interval (8 hour), n=37, 36

QTcB interval (10 hour), n=37, 37

QTcB interval (12 hour), n=37, 37

QTcB interval (24 hour), n=37, 35

RR interval (predose), n=37, 37

RR interval (1 hour), n=37, 37

RR interval (2 hour), n=37, 37

RR interval (3 hour), n=37, 37

RR interval (4 hour), n=37, 37

RR interval (6 hour), n=37, 36

RR interval (8 hour), n=37, 36

RR interval (10 hour), n=37, 37

RR interval (12 hour), n=37, 37

RR interval (24 hour), n=37, 35

PR interval (predose), n=37, 37

PR interval (1 hour), n=37, 37

PR interval (2 hour), n=37, 37

PR interval (3 hour), n=37, 37

PR interval (4 hour), n=37, 37

PR interval (6 hour), n=37, 36

PR interval (8 hour), n=37, 36

PR interval (10 hour), n=37, 37

PR interval (12 hour), n=37, 37

PR interval (24 hour), n=37, 35

QRS interval (predose), n=37, 37

QRS interval (1 hour), n=37, 37

QRS interval (2 hour), n=37, 37

QRS interval (3 hour), n=37, 37

QRS interval (4 hour), n=37, 37

QRS interval (6 hour), n=37, 36

QRS interval (8 hour), n=37, 36

QRS interval (10 hour), n=37, 37

QRS interval (12 hour), n=37, 37

QRS interval (24 hour), n=37, 35

Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.

Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Effect of Repeat Oral Dosing of GSK2118436 on Cardiac Repolarization in Subjects With V600 BRAF Mutation-Positive Tumors	NCT01738451	Cancer	GSK2118436 75 m... Placebo	18 Years -	GlaxoSmithKline
The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms	NCT03177681	Malignant Neopl...	Tongue Assessme... Stool Sample Questionnaires Holter Monitor Yogurt	18 Years -	M.D. Anderson Cancer Center
A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval	NCT01328054	Cancer	lapatinib placebo matchin...	18 Years -	GlaxoSmithKline
The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms	NCT03177681	Malignant Neopl...	Tongue Assessme... Stool Sample Questionnaires Holter Monitor Yogurt	18 Years -	M.D. Anderson Cancer Center
A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval	NCT01328054	Cancer	lapatinib placebo matchin...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for holter monitor