Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | Experimental | Dose escalation of lapatinib along with capecitabine and oxaliplatin until the maximum tolerated dose is reached. |
|
| Phase II | Experimental | Treatinng subjects at the maximum tolerated dose of lapatinib, capecitabine, and oxaliplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lapatinib | Drug | onced daily Days 1-21 |
| |
| oxaliplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response in Phase II | The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study. | Baseline to response (up to 135 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies. | Exploring if there is an association with a reduction in thymidylate synthase (TS) gene expression in both plasma and tumor prior to treatment and increased sensitivity in clinical activity. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. |
Not provided
Inclusion criteria
18 years of age or older.
A female is eligible to enter and participate in the study if she is of:
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
Provided written informed consent.
Hemoglobin greater than or equal to 8 gm/dL (5 nmol/L), if clinically stable.
Absolute neutrophil count greater than or equal to 1,500/mm^3 (1.5 x 109/L).
Calculated creatinine clearance (CrCl) greater than or equal to 50 mls/min.
Total bilirubin less than or equal to 1.25 times the institutional upper limit of normal (ULN).
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2 times the ULN. For subjects with liver metastases: AST or ALT less than or equal to 5 times the ULN.
LVEF greater than or equal to 50% or greater than or equal to LLN for the institution based on multiple gated acquisition scan (MUGA) or echocardiogram (ECHO).
Specific to Phase I:
Recurrent, advanced, or metastatic cancer that is known to be potentially responsive to treatment with fluoropyrimidines or oxaliplatin. Examples include gastrointestinal tumors, HER2 (ErbB2)-positive breast cancer, and lung cancers.
Received less than or equal to 3 prior chemotherapy regimens without pelvic radiotherapy or less than or equal to 2 prior chemotherapy regimens if received pelvic radiotherapy.
Platelet count greater than or equal to 75,000/mm^3 (75 x 109/L).
Specific to Phase II:
Histologically-confirmed, measurable advanced or metastatic CRC previously untreated in the metastatic setting or more than 6 months post an oxaliplatin-containing adjuvant therapy.
Archived paraffin-embedded tumor tissue must be available for biomarker analysis.
Platelet count greater than or equal to 100,000/mm^3 (100 x 109/L).
Exclusion Critera:
Pregnant or lactating female.
Prior resection of the small bowel.
Brain metastases that require additional treatment.
Medically unfit for the study as a result of the medical interview, physical exam, or screening investigations.
Taking any medication on the prohibited medications list (see Section 9.2).
History of drug or other allergy, which, in the opinion of the Investigator, contraindicates participation.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs. These include other anilinoquinazolines, such as gefitinib [Iressa], or erlotinib [Tarceva]. The subject has received treatment with any investigational drug in the previous four weeks.
Treatment with any biologic, cytotoxic, radiation , or hormonal (other than for contraception or replacement) therapy within four weeks. Treatment with hormones with short half-lives is allowed up to 1 week prior to study treatment after consultation with GSK medical monitor.
Major surgery within the previous two weeks unless in the opinion of the Investigator, the subject has recovered sufficiently to begin study treatment.
Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Receiving concurrent coumadin therapy. Minidose coumadin for maintenance of catheters (0.5 to 1.0 mg/day), and other anticoagulation therapy are allowed on study. Subjects receiving minidose coumadin must have prothrombin time (PT) or International normalized ratio (INR) and partial thromboplastin time (PTT) within 1.2 times the ULN.
History of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
Corrected QT interval (QTc) greater than 450 msecs.
Specific to Phase I:
Residual chemotherapy related toxicity of greater than or equal to Grade 2 that is clinically felt likely to be exacerbated by the treatment regimen.
Specific to Phase II (amendment written after the completion of Phase 1):
Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21609937 | Derived | Dennie TW, Fleming RA, Bowen CJ, Dar MM, Alberti D, Oliver K, Loconte N, Mulkerin D, Holen KD. A phase I study of capecitabine, oxaliplatin, and lapatinib in metastatic or advanced solid tumors. Clin Colorectal Cancer. 2011 Mar 1;10(1):57-62. doi: 10.3816/CCC.2011.n.008. |
| Label | URL |
|---|---|
| Results for study EGF108991 can be found on the GSK Clinical Study Register. | View source |
Not provided
Not provided
This was a Phase I/II study. Enrollment of Phase I was complete; however, Phase II of the study was terminated early due to lake of interest by sites in participating. Only 2 of the 15 planned participants were enrolled prior to termination.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lapatinib/Oxaliplatin/Capecitabine | Phase I: Dose escalation to a maximum tolerated dose of lapatinib 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle. Phase II: Lapatinib 1000 mg/day administered orally on Days 1-21, oxaliplatin 130 mg/m^2 administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I (Dose-finding Phase) |
| |||||||||||||
| Phase II |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2 | Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline participants include the 10 participants who completed Phase I, and the 2 who were enrolled into Phase II before the study was terminated. |
| 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 | Overall Response in Phase II | The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study. | All-Treated Population for Phase II: all participants who received at least one dose of lapatinib | Posted | Number | participants | Baseline to response (up to 135 days) |
|
Phases I and II
GSK typically summarizes all AEs and all SAEs. The SAE summary will include participants with only an SAE. The data summarized below under the heading Other AEs (non-serious) are actually a summary of all AEs, which does include some SAEs.
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 | Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2 | Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Phase II of the study was terminated due to lake of interest. Two participants were enrolled prior to termination. Due to the small sample size in Phase II, the data were not analyzed. The two participants' data were analyzed with Phase I data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Day one of each cycle |
|
| capecitabine | Drug | given BID days 1-14 |
|
|
| Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening. |
| Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response | A possible association between a reduction in thymidylate synthase (TS) gene expression and increased sensitivity in clinical activity was to be explored. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible). |
| Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment | Exploring tumor-derived biomarkers including TS, DPD, TP, EGFR (ErbB1), and additional downstream markers involved in the mechanism of action of each compound (e.g., ERCC1) and comparison to clinical response. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days. |
| Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy | DNA sequencing was done to identify genetic aberrations in somatic (tumor) DNA that may associate with clinical outcomes in response to therapy. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3. |
| Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs | This outcome measure was conducted to investigate a possible genetic relationship to handling or response to lapatinib, oxaliplatin, and capecitabine. This measure was not analyzed due to the small number of participants who signed the optional pharmacogenetics consent. | Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible |
| Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II | Both participants that entered Phase II of the study were censored for progression-free survival. Progression-free survival (PFS) is defined as the time from first dose until the first documented sign of disease progression or death due to any cause. For participants who do not progress or die, PFS was censored at the time of last radiological scan preceding the initiation of alternative anti-cancer therapy. Of the 2 participants in Phase II of the study, one discontinued due to adverse events, and the other was referred for a surgical resection. | Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days) |
| Change From Baseline to Study Completion in Weight | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Heart Rate | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Blood Pressure | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Hemoglobin and Neutrophils | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in White Blood Cells and Platelets | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in International Normalized Ratio | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Sodium, Potassium, and Calcium | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Creatinine Clearance | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
| Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | Baseline to study completion (up to 135 days) |
|
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Baseline participants include the 10 participants who completed Phase I, and the 2 who were enrolled into Phase II before the study was terminated. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline participants include the 10 participants who completed Phase I, and the 2 who were enrolled into Phase II before the study was terminated. | Number | participants |
|
|
|
| Secondary | Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies. | Exploring if there is an association with a reduction in thymidylate synthase (TS) gene expression in both plasma and tumor prior to treatment and increased sensitivity in clinical activity. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated population for Phase II | Posted | Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening. |
|
|
| Secondary | Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response | A possible association between a reduction in thymidylate synthase (TS) gene expression and increased sensitivity in clinical activity was to be explored. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated population for Phase II | Posted | Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible). |
|
|
| Secondary | Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment | Exploring tumor-derived biomarkers including TS, DPD, TP, EGFR (ErbB1), and additional downstream markers involved in the mechanism of action of each compound (e.g., ERCC1) and comparison to clinical response. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated population for Phase II | Posted | Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days. |
|
|
| Secondary | Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy | DNA sequencing was done to identify genetic aberrations in somatic (tumor) DNA that may associate with clinical outcomes in response to therapy. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated population for Phase II | Posted | Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3. |
|
|
| Secondary | Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs | This outcome measure was conducted to investigate a possible genetic relationship to handling or response to lapatinib, oxaliplatin, and capecitabine. This measure was not analyzed due to the small number of participants who signed the optional pharmacogenetics consent. | Participants in the All-Treated Population who signed a PGx informed consent. | Posted | Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible |
|
|
| Secondary | Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II | Both participants that entered Phase II of the study were censored for progression-free survival. Progression-free survival (PFS) is defined as the time from first dose until the first documented sign of disease progression or death due to any cause. For participants who do not progress or die, PFS was censored at the time of last radiological scan preceding the initiation of alternative anti-cancer therapy. Of the 2 participants in Phase II of the study, one discontinued due to adverse events, and the other was referred for a surgical resection. | All-Treated Population for Phase II | Posted | Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days) |
|
|
| Secondary | Change From Baseline to Study Completion in Weight | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Heart Rate | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Blood Pressure | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Hemoglobin and Neutrophils | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in White Blood Cells and Platelets | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in International Normalized Ratio | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Sodium, Potassium, and Calcium | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Creatinine Clearance | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| Secondary | Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II. | All-Treated Population for Phase II | Posted | Baseline to study completion (up to 135 days) |
|
|
| 5 |
| 12 |
| 12 |
| 12 |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Laryngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hyperbilirubunaemia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Blindness transient | Eye disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Laryngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Left ventricular dysfunctionation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Oedema | General disorders | MedDRA | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA | Systematic Assessment |
|
| Hyperaesthia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hyporcalceamia | Metabolism and nutrition disorders | MedDRA | 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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |