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To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil) | Drug | FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis. | Up to 11 cycles (1 cycle = 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of enrollment to the date of death due to any cause. OS data was censored on the day following the date of the last contact at which the patient is known to be alive. | Up to 11 cycles (1 cycle = 6 weeks) |
| Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR) |
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 | Nagoya | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22537162 | Derived | Tsuji Y, Satoh T, Tsuji A, Muro K, Yoshida M, Nishina T, Nagase M, Komatsu Y, Kato T, Miyata Y, Mizutani N, Hashigaki S, Lechuga MJ, Denda T. First-line sunitinib plus FOLFIRI in Japanese patients with unresectable/metastatic colorectal cancer: a phase II study. Cancer Sci. 2012 Aug;103(8):1502-7. doi: 10.1111/j.1349-7006.2012.02320.x. Epub 2012 Jun 14. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI | Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI | Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration. |
| 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 | Progression-Free Survival (PFS) | PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis. | Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication. | Posted | Median | 95% Confidence Interval | weeks | Up to 11 cycles (1 cycle = 6 weeks) |
|
Up to 11 cycles (1 cycle = 6 weeks)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI | Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
Not provided
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|
| Sunitinib | Drug | 37.5mg daily P.O., 4 weeks On 2weeks Off each 42 day cycle. Number of cycles: until progression or unacceptable toxicity develops. |
|
|
ORR is defined as the percentage of participants with best overall response of either a confirmed complete (CR) or partial response (PR) relative to the number of participants in FAS. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. |
| Up to 11 cycles (1 cycle = 6 weeks) |
| Duration of Response (DR) | DR is defined as the time from the first objective documentation of complete or partial response that is subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurs first. The definition of censorship is the same as PFS. | Up to 11 cycles (1 cycle = 6 weeks) |
| Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib. | Plasma concentrations were assessed at predose, 2, 4, 6, 8, and 24 hours postdose and Cmax and Ctrough of sunitinib, its metabolite SU012662, and the total (sunitinib + SU0122662) were determined. | Cycle 1 Day 15 |
| Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib | Cycle 1 Day 15 |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib | AUC 0-24 was determined using the Linear/Log trapezoidal method. | Cycle 1 Day 15 |
| Apparent Oral Clearance (CL/F) of Sunitinib | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Cycle 1 Day 15 |
| Maximum Observed Plasma Concentration (Cmax) of Irinotecan | Plasma samples were assessed at prior to initiation of irinotecan (and l-leucovorin) infusion, 1, 2 (predose for 5-FU bolus), 4, 8, and 24 hours after initiation of irinotecan infusion, and Cmax of irinotecan and its metabolite SN-38 were determined. | Cycle 1 Day 15 |
| Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan | Cycle 1 Day 15 |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan | AUC last of irinotecan and its metabolite SN-38 were calculated using the Linear/Log trapezoidal method. AUC∞ of irinotecan was calculated using following equation; AUC last+(C*t/kel), where Ct* is the estimated concentration at the time of the last quantifiable concentration, kel is terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile. | Cycle 1 Day 15 |
| Terminal Phase Elimination Half-life (t1/2) of Irinotecan | Terminal phase half-life of irinotecan was calculated as ln 2/ kel. | Cycle 1 Day 15 |
| Clearance of Irinotecan | CL is calculated as dose divided by AUC 0-∞ | Cycle 1 Day 15 |
| Volume of Distribution at Steady State (Vss) of Irinotecan | Vss was calculated using following equation: CL x mean residence time (MRT), where MRT = the area under the first moment curve from zero time to infinity (AUMC 0-∞)/AUC 0-∞- (infusion time/2), AUMC 0-∞ = the area under the first moment curve from zero time to time t (AUMC t)+ ((t x Ct*)/ kel) + (Ct* / kel^2), AUMC t is calculated using the linear trapezoidal method. | Cycle 1 Day 15 |
| Plasma Concentration at Steady State (Css) of 5-FU | Concentration at 22 hour post start of 5-FU infusion were to be used as Css if 5-FU concentrations suggested steady state at 22 hours time point. | Cycle 1 Day 15 |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE). | Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 11 cycles (1 cycle = 6 weeks) |
| Chiba |
| Chiba |
| Japan |
| Pfizer Investigational Site | Matsuyama | Ehime | Japan |
| Pfizer Investigational Site | Sapporo | Hokkaido | Japan |
| Pfizer Investigational Site | Minoh/Osaka | Japan | Japan |
| Pfizer Investigational Site | Kochi | Kochi | Japan |
| Pfizer Investigational Site | Saku | Nagano | Japan |
| Pfizer Investigational Site | Osakasayama-shi | Osaka | Japan |
| Pfizer Investigational Site | Takatsuki | Osaka | Japan |
| Pfizer Investigational Site | Shimotsuke-shi | Tochigi | Japan |
| Global Deterioration of Health Status |
|
| Withdrawal by Subject |
|
| Surgery |
|
| Subject's work scheduling problem |
|
| Physician Decision |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration. |
|
|
| Secondary | Overall Survival (OS) | OS is defined as the time from the date of enrollment to the date of death due to any cause. OS data was censored on the day following the date of the last contact at which the patient is known to be alive. | Median OS was not calculable due to the large number of censored events (63 out of 71 were censored). | Posted | Median | 95% Confidence Interval | weeks | Up to 11 cycles (1 cycle = 6 weeks) |
|
|
| Secondary | Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with best overall response of either a confirmed complete (CR) or partial response (PR) relative to the number of participants in FAS. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. | Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication. | Posted | Median | 95% Confidence Interval | percentage of participants | Up to 11 cycles (1 cycle = 6 weeks) |
|
|
|
| Secondary | Duration of Response (DR) | DR is defined as the time from the first objective documentation of complete or partial response that is subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurs first. The definition of censorship is the same as PFS. | Analysis set was consisted of participants with a confirmed objective tumor response (CR or PR) among Full Analysis Set. | Posted | Median | 95% Confidence Interval | weeks | Up to 11 cycles (1 cycle = 6 weeks) |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib. | Plasma concentrations were assessed at predose, 2, 4, 6, 8, and 24 hours postdose and Cmax and Ctrough of sunitinib, its metabolite SU012662, and the total (sunitinib + SU0122662) were determined. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 15 |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Full Range | hours | Cycle 1 Day 15 |
|
|
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib | AUC 0-24 was determined using the Linear/Log trapezoidal method. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | ng.h/mL | Cycle 1 Day 15 |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) of Sunitinib | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | L/hour | Cycle 1 Day 15 |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Irinotecan | Plasma samples were assessed at prior to initiation of irinotecan (and l-leucovorin) infusion, 1, 2 (predose for 5-FU bolus), 4, 8, and 24 hours after initiation of irinotecan infusion, and Cmax of irinotecan and its metabolite SN-38 were determined. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 15 |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Full Range | hours | Cycle 1 Day 15 |
|
|
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan | AUC last of irinotecan and its metabolite SN-38 were calculated using the Linear/Log trapezoidal method. AUC∞ of irinotecan was calculated using following equation; AUC last+(C*t/kel), where Ct* is the estimated concentration at the time of the last quantifiable concentration, kel is terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | ng.h/mL | Cycle 1 Day 15 |
|
|
|
| Secondary | Terminal Phase Elimination Half-life (t1/2) of Irinotecan | Terminal phase half-life of irinotecan was calculated as ln 2/ kel. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | hours | Cycle 1 Day 15 |
|
|
|
| Secondary | Clearance of Irinotecan | CL is calculated as dose divided by AUC 0-∞ | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | L/hour | Cycle 1 Day 15 |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) of Irinotecan | Vss was calculated using following equation: CL x mean residence time (MRT), where MRT = the area under the first moment curve from zero time to infinity (AUMC 0-∞)/AUC 0-∞- (infusion time/2), AUMC 0-∞ = the area under the first moment curve from zero time to time t (AUMC t)+ ((t x Ct*)/ kel) + (Ct* / kel^2), AUMC t is calculated using the linear trapezoidal method. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | L | Cycle 1 Day 15 |
|
|
|
| Secondary | Plasma Concentration at Steady State (Css) of 5-FU | Concentration at 22 hour post start of 5-FU infusion were to be used as Css if 5-FU concentrations suggested steady state at 22 hours time point. | Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1 Day 15 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE). | Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set was defined as the same population as the Full Analysis Set. | Posted | Number | Participants | Up to 11 cycles (1 cycle = 6 weeks) |
|
|
|
| 32 |
| 71 |
| 71 |
| 71 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
| Title | Measurements |
|---|---|
|
| SU012662 Ctrough |
|
| Total (sunitinib + SU0122662) Cmax |
|
| Total (sunitinib + SU0122662) Ctrough |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| CTCAE grade 5 adverse events |
|