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To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sunitinib | Experimental | single agent sunitinib, single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib Malate (SU011248) | Drug | Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. | Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. | Baseline (Day 1) to death (up to 282 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tumor Response (TTR) | TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed. | Baseline (Day 1) to tumor response (up to 82 weeks) |
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 |
|---|---|---|---|---|---|---|
| Nanjing Bayi Hospital | Nanjing | Jiangsu | 210002 | China | ||
| Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sutent (Sunitinib Malate) | The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Objective Response Rate (ORR) |
ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Baseline (Day 1) up to end of study treatment (up to 276 weeks) |
| Time to Tumor Progression (TTP) | TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0. | Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks) |
| Number of Participants With Abnormal Clinical Laboratory Measurements | The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests. | Baseline up to 28 days post last administration of study drug |
| Number of Participants With Significant Changes From Baseline in Physical Examination. | Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed. | Baseline up to 28 days post last administration of study drug |
| Number of Participants With Significant Vital Signs Changes From Baseline | Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline. | Baseline (Day 1) up to 28 days post last administration of study drug |
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 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 or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead). | Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug) |
| Beijing |
| 100021 |
| China |
| Beijing Cancer Hospital | Beijing | 100035 | China |
| 307 Hospital of PLA | Beijing | 100071 | China |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who started study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sutent (Sunitinib Malate) | The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. | Safety analysis included all participants who started study treatment. | Posted | Median | 95% Confidence Interval | weeks | Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks) |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. | Safety analysis set included all participants who started study treatment. | Posted | Median | 95% Confidence Interval | weeks | Baseline (Day 1) to death (up to 282 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment. | Posted | Number | 95% Confidence Interval | % of participants | Baseline (Day 1) up to end of study treatment (up to 276 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Time to Tumor Progression (TTP) | TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0. | Safety analysis set included all participants who started study treatment. | Posted | Median | 95% Confidence Interval | weeks | Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks) |
| |||||||||||||||||||||||||||
| Other Pre-specified | Time to Tumor Response (TTR) | TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed. | All participants who started study treatment (safety analysis set) had a confirmed objective tumor response. | Posted | Median | 95% Confidence Interval | weeks | Baseline (Day 1) to tumor response (up to 82 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Clinical Laboratory Measurements | The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests. | Safety analysis set included all participants who started study treatment. | Posted | Number | participants | Baseline up to 28 days post last administration of study drug |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Significant Changes From Baseline in Physical Examination. | Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed. | Safety analysis set included all participants who started study treatment. | Posted | Number | participants | Baseline up to 28 days post last administration of study drug |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Significant Vital Signs Changes From Baseline | Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline. | Safety analysis set included all participants who started study treatment. | Posted | Number | participants | Baseline (Day 1) up to 28 days post last administration of study drug |
| ||||||||||||||||||||||||||||
| Secondary | Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 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 or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead). | Safety analysis set included all participants who started study treatment. | Posted | Number | participants | Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug) |
|
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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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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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 | Sutent (Sunitinib Malate) | The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met. | 12 | 59 | 57 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Neutrophil percentage decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eyelash hyperpigmentation | Eye disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Mucous membrane disorder | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hepatic mass | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pericoronitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Protein urine | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Thyroxine free decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Thyroxine increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tri-iodothyronine free decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemoglobinuria | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
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