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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-070386 |
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Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.
Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SU011248 | Experimental | 25 , 50 or 75 mg/day of SU011248 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib malate (SU011248) | Drug | SU011248 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Dose Limiting Toxicities (DLT) | Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1. | Cycle 1 (Baseline to Week 6) |
| Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1 | Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662). | Day 1 of Cycle 1 |
| Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28 | Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662). | Day 28 of Cycle 1 |
| Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1 | Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662). | Day 1 of Cycle 1 |
| Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28 | Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662). |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) | Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF) | Day 1, 14, 28 of Cycles 1-4 |
| Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kashiwa | Chiba | Japan | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Phase 1 only included Cycle 1 for subjects enrolled in Phase 1. Phase 2 was comprised of either Cycle 2 and beyond for subjects who were enrolled in Phase 1, or all cycles for newly enrolled subjects. Additional subjects were enrolled to make a total of 30 in the recommended dose level (50-mg).
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| ID | Title | Description |
|---|---|---|
| FG000 | SU-011248 25-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. |
| FG001 | SU-011248 50-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose. |
| FG002 | SU-011248 75-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SU-011248 25-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Subjects With Dose Limiting Toxicities (DLT) | Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1. | DLT analysis population consists of subjects who developed DLT or received 85% of the planned dose. One subject in 75-mg dose group was excluded from DLT analysis population because the subject received less than 85% of the planned dose. | Posted | Number | participants | Cycle 1 (Baseline to Week 6) |
|
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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 | SU-011248 25-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Day 28 of Cycle 1 |
| Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1 | Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662). | Day 1 of Cycle 1 |
| Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28 | Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662). | Day 28 of Cycle 1 |
| SU-011248 Clearance on Cycle 1 Day 28 | SU-011248 Clearance in the subjects enrolled in Phase 1. Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL). | Day 28 of Cycle 1 |
| Accumulation Ratio (Rac) on Cycle 1 Day 28 | Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1. Rac was the ratio of Day 28 to Day 1. | Day 28 of Cycle 1 |
| Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group | Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). | Day 28 of Cycles 1-4 |
Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) |
| Day 1, 14, 28 of Cycles 1-4 |
| Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT) | Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT) | Day 1, 14, 28 of Cycles 1-4 |
| Trough Plasma Concentration (Ctrough) of SU-011248 | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 |
| Trough Plasma Concentration (Ctrough) of SU-012262 | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 |
| Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 |
| Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires | Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A). The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated. Change from Baseline: Score at each observation minus score at baseline | Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4 |
| Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires | The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health. Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline | Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4 |
| Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group | Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). | Day 28 of Cycles 1-4 |
| Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group | Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). | Day 28 of Cycles 1-4 |
| Time To Tumor Progression (TTP) | Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD). | From the first dose to Progressive Disease |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death. | From the first dose to Progressive Disease or Death |
| Time To Failure (TTF) | Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. | From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer. |
| Overall Survival Time | Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive. Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once. | From the first dose to death |
| Sapporo |
| Hokkaido |
| Japan |
| Pfizer Investigational Site | Suita | Osaka | Japan |
| Pfizer Investigational Site | Chuo-ku | Tokyo | Japan |
| BG001 | SU-011248 50-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose. |
| BG002 | SU-011248 75-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. |
| BG003 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. | Number | participants |
|
| OG001 | SU-011248 50-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose. |
| OG002 | SU-011248 75-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. |
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| Primary | Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1 | Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662). | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. | Posted | Mean | Standard Deviation | ng/mL | Day 1 of Cycle 1 |
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| Secondary | Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) | Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF) | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | pg/mL | Day 1, 14, 28 of Cycles 1-4 |
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| Secondary | Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) | Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | pg/mL | Day 1, 14, 28 of Cycles 1-4 |
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| Secondary | Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT) | Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT) | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | pg/mL | Day 1, 14, 28 of Cycles 1-4 |
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| Secondary | Trough Plasma Concentration (Ctrough) of SU-011248 | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | ng/mL | Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 |
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| Secondary | Trough Plasma Concentration (Ctrough) of SU-012262 | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | ng/mL | Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 |
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| Secondary | Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | ng/mL | Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 |
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| Secondary | Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires | Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A). The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated. Change from Baseline: Score at each observation minus score at baseline | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | scores on a scale | Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4 |
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| Secondary | Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires | The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health. Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. n= Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | index scores on a scale | Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4 |
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| Secondary | Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group | Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Number | participants | Day 28 of Cycles 1-4 |
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| Primary | Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28 | Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662). | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. 3 subjects in 75mg dose group discontinued before Cycle 1 Day 28, therefore no data presented. | Posted | Mean | Standard Deviation | ng/mL | Day 28 of Cycle 1 |
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| Secondary | Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group | Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). | ITT population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Number | participants | Day 28 of Cycles 1-4 |
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| Secondary | Time To Tumor Progression (TTP) | Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD). | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | Weeks | From the first dose to Progressive Disease |
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| Primary | Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1 | Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662). | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. | Posted | Mean | Standard Deviation | ng•h/mL | Day 1 of Cycle 1 |
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| Primary | Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28 | Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662). | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. 3 subjects in 75-mg dose group discontinued the dose on Cycle1, therefore no data showed. | Posted | Mean | Standard Deviation | ng•h/mL | Day 28 of Cycle 1 |
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| Primary | Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1 | Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662). | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. | Posted | Median | Full Range | hours | Day 1 of Cycle 1 |
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| Primary | Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28 | Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662). | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. 3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented. | Posted | Median | Full Range | hours | Day 28 of Cycle 1 |
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| Secondary | Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death. | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | Weeks | From the first dose to Progressive Disease or Death |
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|
|
| Primary | SU-011248 Clearance on Cycle 1 Day 28 | SU-011248 Clearance in the subjects enrolled in Phase 1. Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL). | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. 3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented. | Posted | Mean | Standard Deviation | L/h | Day 28 of Cycle 1 |
|
|
|
| Primary | Accumulation Ratio (Rac) on Cycle 1 Day 28 | Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1. Rac was the ratio of Day 28 to Day 1. | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. 3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented. | Posted | Mean | Standard Deviation | ratio | Day 28 of Cycle 1 |
|
|
|
| Primary | Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group | Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Number | participants | Day 28 of Cycles 1-4 |
|
|
|
|
| Secondary | Time To Failure (TTF) | Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | Weeks | From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer. |
|
|
|
| Secondary | Overall Survival Time | Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive. Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once. | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | Weeks | From the first dose to death |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | SU-011248 50-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose. | 12 | 30 | 30 | 30 |
| EG002 | SU-011248 75-mg | Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment. Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted. Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria. | 2 | 3 | 3 | 3 |
| Altered state of consciousness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Leucine aminopeptidase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Periproctitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | Systematic Assessment |
|
| Protein urine | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| SU-011248+SU-012662 |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Day 1 (n=26) |
|
| Cycle 2 Day 14 (n=24) |
|
| Cycle 2 Day 28 (n=20) |
|
| Cycle 3 Day 1 (n=18) |
|
| Cycle 3 Day 14 (n=19) |
|
| Cycle 3 Day 28 (n=13) |
|
| Cycle 4 Day 1 (n=11) |
|
| Cycle 4 Day 14 (n=12) |
|
| Cycle 4 Day 28 (n=9) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Day 1 (n=26) |
|
| Cycle 2 Day 14 (n=24) |
|
| Cycle 2 Day 28 (n=20) |
|
| Cycle 3 Day 1 (n=18) |
|
| Cycle 3 Day 14 (n=19) |
|
| Cycle 3 Day 28 (n=13) |
|
| Cycle 4 Day 1 (n=11) |
|
| Cycle 4 Day 14 (n=12) |
|
| Cycle 4 Day 28 (n=9) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Day 1 (n=26) |
|
| Cycle 2 Day 14 (n=24) |
|
| Cycle 2 Day 28 (n=20) |
|
| Cycle 3 Day 1 (n=18) |
|
| Cycle 3 Day 14 (n=19) |
|
| Cycle 3 Day 28 (n=13) |
|
| Cycle 4 Day 1 (n=11) |
|
| Cycle 4 Day 14 (n=12) |
|
| Cycle 4 Day 28 (n=9) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Day 14 (n=23) |
|
| Cycle 2 Day 28 (n=20) |
|
| Cycle 3 Day 1 (n=11) |
|
| Cycle 3 Day 14 (n=14) |
|
| Cycle 3 Day 28 (n=10) |
|
| Cycle 4 Day 1 (n=5) |
|
| Cycle 4 Day 14 (n=7) |
|
| Cycle 4 Day 28 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Day 14 (n=23) |
|
| Cycle 2 Day 28 (n=20) |
|
| Cycle 3 Day 1 (n=11) |
|
| Cycle 3 Day 14 (n=14) |
|
| Cycle 3 Day 28 (n=10) |
|
| Cycle 4 Day 1 (n=5) |
|
| Cycle 4 Day 14 (n=7) |
|
| Cycle 4 Day 28 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2 Day 14 (n=23) |
|
| Cycle 2 Day 28 (n=20) |
|
| Cycle 3 Day 1 (n=11) |
|
| Cycle 3 Day 14 (n=14) |
|
| Cycle 3 Day 28 (n=10) |
|
| Cycle 4 Day 1 (n=5) |
|
| Cycle 4 Day 14 (n=7) |
|
| Cycle 4 Day 28 (n=8) |
|
| Title | Measurements |
|---|---|
|
| Cycle 1 Day 28 (n=30) |
|
| Cycle 1 Day 35 (n=30) |
|
| Cycle 2 Day 1 (n=30) |
|
| Cycle 2 Day 7 (n=30) |
|
| Cycle 2 Day 14 (n=30) |
|
| Cycle 2 Day 21 (n=30) |
|
| Cycle 2 Day 28 (n=29) |
|
| Cycle 2 Day 35 (n=29) |
|
| Cycle 3 Day 1 (n=25) |
|
| Cycle 3 Day 7 (n=24) |
|
| Cycle 3 Day 14 (n=25) |
|
| Cycle 3 Day 21 (n=24) |
|
| Cycle 3 Day 28 (n=25) |
|
| Cycle 3 Day 35 (n=25) |
|
| Cycle 4 Day 1 (n=21) |
|
| Cycle 4 Day 7 (n=20) |
|
| Cycle 4 Day 14 (n=21) |
|
| Cycle 4 Day 21 (n=20) |
|
| Cycle 4 Day 28 (n=19) |
|
| Cycle 4 Day 35 (n=20) |
|
| Title | Measurements |
|---|---|
|
| Cycle 3 Day 1 (n=25) |
|
| Cycle 3 Day 28 (n=25) |
|
| Cycle 4 Day 1 (n=21) |
|
| Cycle 4 Day 28 (n=18) |
|
| Title | Measurements |
|---|---|
|
| Stable Disease (SD) >= 10 weeks |
|
| SU-011248+SU-012662 |
|
| Title | Measurements |
|---|---|
|
|
| SU-011248+SU-012662 |
|
| SU-011248+SU-012662 |
|
|
| SU-011248+SU-012662 |
|
| SU-011248+SU-012662 |
|
| SU-012662: Rac Cmax |
|
| SU-012662: Rac AUC0-24 |
|
| SU-011248+SU-012662: Rac Cmax |
|
| SU-011248+SU-012662: Rac AUC0-24 |
|
| Title | Measurements |
|---|---|
|
| Stable Disease (SD) >= 22 weeks |
|