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To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SU-011248 capsule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SU011248 capsule | Drug | 50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Objective Response | Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Day 28 of Cycles 1-4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug. |
Not provided
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 | Akita | Akita | Japan | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | First-line Treatment Population | SU-011248 capsule: Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria. |
| FG001 | Pretreated Population | SU-011248 capsule: Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | First-line Treatment Population | SU-011248 capsule: Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation 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 Objective Response | Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | 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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | SU-011248 Capsule:First-line Treatment population plus Pretreated population |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| C536415 | Primary hyperoxaluria type 2 |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
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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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| 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). | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug. |
| Duration of Response (DR) | Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study. | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug. |
| Time to Tumor Response (TTR) | Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. |
| 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 subject was known to be alive. | once year. Up to 3 years after the completion of subject registration. |
| Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score | Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D 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 (Range: 0 to 1). High score is indicating high health. | Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4 |
| Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS) | Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline. The VAS is a self-completed scale designed to rate the subject's current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4 |
| Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population | Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration. | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population | SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population | SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population | SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject. | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population | SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject. | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) | Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF) | Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| 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) | Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
| Sapporo |
| Hokkaido |
| Japan |
| Pfizer Investigational Site | Tsukuba | Ibaragi | Japan |
| Pfizer Investigational Site | Osaka | Osaka | Japan |
| Pfizer Investigational Site | Sayama | Osaka | Japan |
| Pfizer Investigational Site | Hamamatsu | Shizuoka | Japan |
| Pfizer Investigational Site | Sunto-gun | Shizuoka | Japan |
| Pfizer Investigational Site | Tokushima | Tokushima | Japan |
| Pfizer Investigational Site | Chuo-ku | Tokyo | Japan |
| Pfizer Investigational Site | Yamagata | Yamagata | Japan |
| Pfizer Investigational Site | Fukuoka | Japan |
| Death |
|
| Laboratory Test Abnormality |
|
| BG001 | Pretreated Population | SU-011248 capsule: Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Score 0: Fully active, able to carry on all pre-disease performance without restriction. Score 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 | Pretreated Population | SU-011248 capsule: Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria. |
|
|
|
| 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 | Full Range | Weeks | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug. |
|
|
|
| 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 | Full Range | Weeks | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug. |
|
|
|
| Secondary | Duration of Response (DR) | Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study. | Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively. | Posted | Median | Full Range | Weeks | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug. |
|
|
|
| Secondary | Time to Tumor Response (TTR) | Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively. | Posted | Median | Full Range | Weeks | Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. |
|
|
|
| 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 subject was known to be alive. | Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. | Posted | Median | Full Range | Weeks | once year. Up to 3 years after the completion of subject registration. |
|
|
|
| Secondary | Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score | Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D 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 (Range: 0 to 1). High score is indicating high health. | 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 28 of Cycle 1; Days 1 and 28 of Cycles 2-4 |
|
|
|
| Secondary | Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS) | Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline. The VAS is a self-completed scale designed to rate the subject's current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | 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 28 of Cycle 1; Days 1 and 28 of Cycles 2-4 |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population | 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 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data. | Posted | Median | Full Range | ng/mL | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population | 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 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data. Descriptive statistics on "Cycle 2 Day 1" and "Cycle 3 Day 28" were not calculated because number of subjects with analyzable data was less than 3. | Posted | Median | Full Range | ng/mL | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population | SU-012662 is a metabolite 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 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data. | Posted | Median | Full Range | ng/mL | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population | SU-012662 is a metabolite 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 plasma concentration data for Pharmacokinetic analysis. Descriptive statistics on "Cycle 2 Day 1" and "Cycle 3 Day 28" were not calculated because number of subjects with analyzable data was less than 3. n=Number of subjects with analyzable data. | Posted | Median | Full Range | ng/mL | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population | SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject. | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data. | Posted | Median | Full Range | ng/mL | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population | SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject. | All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. Descriptive statistics on "Cycle 2 Day 1" and "Cycle 3 Day 28" were not calculated because number of subjects with analyzable data was less than 3. n=Number of subjects with analyzable data. | Posted | Median | Full Range | ng/mL | Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| 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 plasma concentration data for Pharmacodynamic analysis. n=Number of subjects with analyzable data. | Posted | Median | Full Range | pg/mL | Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| 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 plasma concentration data for Pharmacodynamic analysis. n=Number of subjects with analyzable data. | Posted | Median | Full Range | pg/mL | Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3 |
|
|
|
| 28 |
| 51 |
| 51 |
| 51 |
| Atrial fibrillation | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (11.1) | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA (11.1) | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (11.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Anal erosion | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Periproctitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.1) | 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 creatine phosphokinase increased | 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 increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Blood thyroid stimulating hormone 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 |
|
| Blood urine present | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | 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 | MedDRA (11.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Scrotal ulcer | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal 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 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Achromotrichia acquired | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue 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 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.1) | 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.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Cycle 2 Day 28 (n=20, 22) |
|
| Cycle 3 Day 1 (n=17, 21) |
|
| Cycle 3 Day 28 (n=17, 21) |
|
| Cycle 4 Day 1 (n=14, 19) |
|
| Cycle 4 Day 28 (n=14, 21) |
|
| Cycle 2 Day 28 (n=20, 22) |
|
| Cycle 3 Day 1 (n=17, 21) |
|
| Cycle 3 Day 28 (n=17, 21) |
|
| Cycle 4 Day 1 (n=14, 19) |
|
| Cycle 4 Day 28 (n=14, 21) |
|
|
| Cycle 2 Day 28 (n=4) |
|
| Cycle 3 Day 28 (n=4) |
|
|
|
| Cycle 2 Day 28 (n=4) |
|
| Cycle 3 Day 28 (n=4) |
|
|
|
| Cycle 2 Day 28 (n=4) |
|
| Cycle 3 Day 28 (n=4) |
|
|
|
| Cycle 2 Day 1 (n=18) |
|
| Cycle 2 Day 28 (n=8) |
|
| Cycle 3 Day 28 (n=6) |
|
|
| Cycle 2 Day 1 (n=18) |
|
| Cycle 2 Day 28 (n=8) |
|
| Cycle 3 Day 28 (n=6) |
|