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This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.
This study is being conducted to characterize the safety/tolerability of pazopanib and lapatinib when administered in combination with enzyme-inducing anticonvulsants in patients with recurrent Grade III or IV malignant gliomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination | Experimental | Pazopanib and Lapatinib in combination. Subjects remain on treatment until disease progression or withdrawal from study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pazopanib | Drug | Pazopanib is a novel compound being developed for the treatment of various cancers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Change From Baseline to Study Completion in Systolic Blood Pressure | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury. | Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II) |
| Number of Participants With the Indicated Change From Baseline to Study Completion in Diastolic Blood Pressure | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury. | Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II) |
| Number of Participants With the Indicated 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 (BL) values to investigate what changes occurred. bpm, beats per minute. | Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Albumin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, the Time to Maximum Observed Concentration (Tmax) and C24 of Pazopanib and Lapatinib When Administered in Combination With EIAC. | Completed during first cycle of treatment. | |
| Phase II: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, Tmax, and C24 of Pazopanib and Lapatinib, as Appropriate, When Administered Together in Combination With Non-EIAC. |
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Inclusion criteria:
Phase I
Phase I and II
Male or female, age at least 18 years of age.
Eastern Cooperative Oncology Group (ECOG) status 0 to 1 as per protocol.
Clinical lab results as per protocol
Has a left ventricular ejection fraction (LVEF) at least 50% based on echocardiogram (ECHO) or Multi Gated Aquisition (MUGA) or within the institutional normal range.
Adequate renal function
Creatinine clearance more than 50 mL/min as calculated by the Cockcroft-Gault formula as per protocol.
Urine Protein Creatinine (UPC) ratio of less than or equal to 1 as per protocol.
Able to swallow and retain oral medications.
A woman is eligible to enter and participate in the study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
Has had a hysterectomy,
Has had a bilateral oophorectomy (ovariectomy),
Has had a bilateral tubal ligation,
Is post-menopausal (total cessation of menses for at least 1 year)
- Childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female.
Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
If sexually active, patients will continue the recommended contraceptive measures for the duration of the treatments and for 28 days following discontinuation of therapy.
Signed informed consent approved by the Institutional Review Board prior to patient entry.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23054212 | Derived | de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6. |
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Phase I and Phase II had two separate participant populations. Enrollment in Phase II was not dependent on the number of participants completing Phase I.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg | Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort. |
| FG001 | Phase II: Biomarker Positive | All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN). |
| FG002 | Phase II: Biomarker Negative | All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I: Dose Escalation |
|
| |||||||||||||||||||||
| Phase II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg | Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number of participants falling into the indicated age groups. |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Phase I: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, the Time to Maximum Observed Concentration (Tmax) and C24 of Pazopanib and Lapatinib When Administered in Combination With EIAC. | Not Posted | Completed during first cycle of treatment. | |||||||||||||
| Secondary | Phase II: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, Tmax, and C24 of Pazopanib and Lapatinib, as Appropriate, When Administered Together in Combination With Non-EIAC. | Not Posted | Completed during first cycle of treatment. |
Serious adverse events (SAEs) and non-serious AES in Phases I and II were collected from Day 1 of study treatment to study completion (up to 844 days for Phase I; up to 878 days for Phase II).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg | Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D012008 | Recurrence |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
| D000077341 | Lapatinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| lapatinib | Drug | Lapatinib is a novel compound being developed for the treatment of various cancers. |
|
|
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Amylase and Lipase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Total Bilirubin and Creatinine | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroxine and Free T3 (Triiodothyronine) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroid Stimulating Hormone | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Total T3 | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Hemoglobin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Hematocrit | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for International Normalized Ratio (Prothrombin Time) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase II of the Study for Partial Thromboplastin Time and Prothrombin Time | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting. | Baseline to study completion (up to 878 days for Phase II) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Albumin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Amylase and Lipase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Total Bilirubin and Creatinine | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroxine | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Free T3 (Triiodothyronine) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroid Stimulating Hormone | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Total T3 | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Hemoglobin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Hematocrit | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for International Normalized Ratio (Prothrombin Time) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample. | Baseline to study completion (up to 844 days for Phase I) |
| Mean Change From Baseline to Maximum Value in Phase I of the Study for Partial Thromboplastin Time and Prothrombin Time | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting. | Baseline to study completion (up to 844 days for Phase I) |
| Number of Participants Experiencing a Dose-limiting Toxicity at the Indicated Dose | A dose-limiting toxicity (DLT) is defined as predefined adverse events or events that prevented participants from receiving 75% of their scheduled doses or from starting their next treatment period. The dose at which no more than 1 out of 6 participants experiences a DLT is defined as the optimally tolerated regimen. The OTR is important because it determines the highest dose combination that can be given without significant toxicity. | Cycle 1 in Phase I (up to Day 28) |
| Overall Response (OR) in Phase II Based GlaxoSmithKline's Evaluation | OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w. | Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878) |
| Overall Response (OR) in Phase II Based on the Investigator-assigned Response | OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w. | Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878) |
| Overall Response (OR) in Phase II Based on an Independent Radiologist's Review | OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w. | Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878) |
| Progression-free Survival at 6 Months | Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. The participants who are still alive and whose follow-up extends to at least 6 months are considered At Risk. | Date of the first dose of study drug to 6 months |
| Completed during first cycle of treatment. |
| Phase II: Plasma Concentrations of the Circulating Biomarkers VEGF, sVEGFR-1, and sVEGFR-2. | Completed during first cycle of treatment. |
| Progression-free Survival | Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. | Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878) |
| Time to Disease Progression or Death Due to Any Cause | Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878) |
| Death |
|
| Physician Decision |
|
| Transition to Extension Phase |
|
| NOT COMPLETED |
|
|
| BG001 | Phase II: Biomarker Positive | All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN). |
| BG002 | Phase II: Biomarker Negative | All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN. |
| BG003 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Secondary | Phase II: Plasma Concentrations of the Circulating Biomarkers VEGF, sVEGFR-1, and sVEGFR-2. | Not Posted | Completed during first cycle of treatment. |
| Primary | Number of Participants With the Indicated Change From Baseline to Study Completion in Systolic Blood Pressure | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury. | All-treated Population (all participants who were given any dose of study medication) for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant. | Posted | Number | participants | Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II) |
|
|
|
| Primary | Number of Participants With the Indicated Change From Baseline to Study Completion in Diastolic Blood Pressure | Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury. | All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant. | Posted | Number | participants | Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II) |
|
|
|
| Primary | Number of Participants With the Indicated 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 (BL) values to investigate what changes occurred. bpm, beats per minute. | All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant. | Posted | Number | participants | Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Albumin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | International Units per Liter (IU/L) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Amylase and Lipase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | Units per liter (U/L) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Total Bilirubin and Creatinine | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | micromoles per liter (µmol/l) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/l) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroxine and Free T3 (Triiodothyronine) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | picomoles per liter (pmol/l) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroid Stimulating Hormone | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | milliunits per liter (mU/L) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Total T3 | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/l) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Hemoglobin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Hematocrit | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells. | All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | percent | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | giga (10^9) per liter (GI/L) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for International Normalized Ratio (Prothrombin Time) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample. | All-treated Population for Phase. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | ratio | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase II of the Study for Partial Thromboplastin Time and Prothrombin Time | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting. | All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | seconds (sec) | Baseline to study completion (up to 878 days for Phase II) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Albumin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | International Units per Liter (IU/L) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Amylase and Lipase | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | Units per liter (U/L) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Total Bilirubin and Creatinine | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | micromoles per liter (µmol/l) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/l) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroxine | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | picomoles per liter (pmol/l) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Free T3 (Triiodothyronine) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments. | Posted | Mean | Standard Deviation | picomoles per liter (pmol/l) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroid Stimulating Hormone | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | milliunits per liter (mU/L) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Total T3 | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/l) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Hemoglobin | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | grams per Liter (g/L) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Hematocrit | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells. | All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | percent | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. | All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | giga (10^9) per liter (GI/L) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for International Normalized Ratio (Prothrombin Time) | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample. | All-treated Population for Phases I and II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | ratio | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Mean Change From Baseline to Maximum Value in Phase I of the Study for Partial Thromboplastin Time and Prothrombin Time | Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting. | All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline. | Posted | Mean | Standard Deviation | seconds (sec) | Baseline to study completion (up to 844 days for Phase I) |
|
|
|
| Primary | Number of Participants Experiencing a Dose-limiting Toxicity at the Indicated Dose | A dose-limiting toxicity (DLT) is defined as predefined adverse events or events that prevented participants from receiving 75% of their scheduled doses or from starting their next treatment period. The dose at which no more than 1 out of 6 participants experiences a DLT is defined as the optimally tolerated regimen. The OTR is important because it determines the highest dose combination that can be given without significant toxicity. | All-treated Population for Phase I | Posted | Number | participants | Cycle 1 in Phase I (up to Day 28) |
|
|
|
| Primary | Overall Response (OR) in Phase II Based GlaxoSmithKline's Evaluation | OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w. | All-treated Population in Phase II who also had a response assessment | Posted | Number | participants | Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878) |
|
|
|
| Primary | Overall Response (OR) in Phase II Based on the Investigator-assigned Response | OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w. | All-treated Population for Phase II who also had a response assessment. | Posted | Number | participants | Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878) |
|
|
|
| Secondary | Progression-free Survival | Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. | All-treated Population for Phase II | Posted | Number | participants | Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878) |
|
|
|
| Secondary | Time to Disease Progression or Death Due to Any Cause | All-treated Population for Phase II | Posted | Median | 95% Confidence Interval | days | Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878) |
|
|
|
| Primary | Overall Response (OR) in Phase II Based on an Independent Radiologist's Review | OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w. | All-treated Population for Phase II who also had a response assessment | Posted | Number | participants | Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878) |
|
|
|
| Primary | Progression-free Survival at 6 Months | Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. The participants who are still alive and whose follow-up extends to at least 6 months are considered At Risk. | All-treated Population for Phase II | Posted | Number | participants | Date of the first dose of study drug to 6 months |
|
|
|
| 15 |
| 34 |
| 33 |
| 34 |
| EG001 | Phase II: Biomarker Positive | All participants received pazopanib 400 mg twice daily (QD) and lapatinib 1000 mg QD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN). | 6 | 19 | 18 | 19 |
| EG002 | Phase II: Biomarker Negative | All participants received pazopanib 400 mg QD and lapatinib 1000 mg QD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN. | 8 | 22 | 22 | 22 |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tumor hemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA | Systematic Assessment |
|
| Hyperbilirubinaemia/blood bilirubin increased | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Mood altered/mood swings | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Decreased appetitie | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pyramidal tract syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cranial nerve disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hair color changes | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | 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 |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001254 | Astrocytoma |
|
| BL, 90-<140 mmHg; shift to post-BL, >=170 mmHg |
|
| BL, 140-<170 mmHg; shift to post-BL, 90-<140 mmHg |
|
| BL, 140-<170 mmHg; shift to post-BL, 140-<170 mmHg |
|
| BL, 140-<170 mmHg; shift to post-BL, >=170 mmHg |
|
| BL, >=170 mmHg; shift to post-BL, 140-<170 mmHg |
|
|
| BL, 90-<110 mmHg; shift to post-BL, 50-<90 mmHg |
|
| BL, 90-<110 mmHg; shift to post-BL, 90-<110 mmHg |
|
| BL, 90-<110 mmHg; shift to post-BL, >=110 mmHg |
|
|
| BL, 101-120 bpm; shift to post-BL, 101-120 bpm |
|
| BL, 101-120 bpm; shift to post-BL, >120 bpm |
|
| BL, >120 bpm; shift to post-BL, 44-100 bpm |
|
| BL, missing; shift to post-BL, 44-100 bpm |
|
| Aspartate aminotransferase, n=19, 22 |
|
| Lactate dehydrogenase, n=18, 19 |
|
| Potassium, n=19, 21 |
|
| Magnesium, n=19, 19 |
|
| Sodium, n=19, 21 |
|
| Urea, n=19, 21 |
|
| Inorganic phosphorus, n=19, 20 |
|
| Platelet count, n=19, 22 |
|
| White blood cells, n=19, 22 |
|
| Alanine aminotransferase |
|
| Aspartate aminotransferase |
|
| Lactate dehydrogenase |
|
| Lipase |
|
| Creatinine |
|
| Glucose |
|
| Potassium |
|
| Magnesium |
|
| Sodium |
|
| Urea |
|
| Inorganic phosphorus |
|
| Total Neutrophils, n=3, 6, 4, 6, 6, 6 |
|
| Platelet count, n=4, 6, 5, 6, 6, 6 |
|
| White blood cell count, n=4, 6, 5, 6, 6, 6 |
|
| Prothrombin time |
|
| Stable disease, >=8 weeks |
|
| Progressive disease, <8 weeks |
|
| Progressive disease |
|
| Stable disease, >=8 weeks |
|
| Progressive disease, <8 weeks |
|
| Progressive disease |
|
| Censored |
|
| Stable disease, >=8 weeks |
|
| Progressive disease, <8 weeks |
|
| Progressive disease |
|
| Unconfirmed partial response |
|
| Censored at or prior to 6 months |
|
| At risk beyond 6 months |
|