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To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule
Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SU011248 | Drug | 37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Benefit Response (CBR) According to RECIST | CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders. | Planned duration on this protocol of up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants by Best Confirmed Response Category According to RECIST | Best confirmed response (BCR) defined as best response [confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks. | Planned duration on this protocol of up to 1 year |
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 | Boston | Massachusetts | 02115 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Must have failed prior treatment with imatinib mesylate (IM) [defined as progression of disease using Response Evaluation Criteria in Solid Tumors(RECIST) or World Health Organization(WHO) criteria, or significant toxicity during treatment with IM precluding further treatment & Eastern Cooperative Oncology Group(ECOG) performance status of 0-1]
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| ID | Title | Description |
|---|---|---|
| FG000 | AM Dose Sunitinib Malate | Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. |
| FG001 | PM Dose Sunitinib Malate | Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AM Dose Sunitinib Malate | Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Participants With Clinical Benefit Response (CBR) According to RECIST | CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders. | ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. CR+PR+(SD for >=24 weeks) | Posted | Number | participants | Planned duration on this protocol of up to 1 year |
|
Not provided
Not provided
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 | AM Dose Sunitinib Malate | Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. |
| 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 |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Participants With Overall Confirmed Objective Disease Response (ORR) | Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. | Planned duration on this protocol of up to 1 year |
| Duration of Stable Disease | Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first. | Planned duration on this protocol of up to 1 year |
| Progression-free Survival (PFS) | PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first. | Planned duration on this protocol of up to 1 year |
| Time to Tumor Progression (TTP) | TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication. | Planned duration on this protocol of up to 1 year |
| Duration of Tumor Response (DR) [Descriptive Statistics] | DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. | Planned duration on this protocol of up to 1 year |
| Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication. | Survival status was collected by telephone contact every 2 months for up to 2 years from study entry. |
| Score of FACIT-Fatigue Scale | FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for >=10 subjects. | Baseline, Day 1 & 15 of each treatment cycle |
| Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for >=10 subjects. | Baseline, Day 1 &15 of each treatment cycle up to 1 year on study |
| Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for >=10 subjects). | Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study |
| Lyon |
| 69373 |
| France |
| Pfizer Investigational Site | Villejuif | 94805 | France |
| Pfizer Investigational Site | Milan | 20133 | Italy |
| Adverse Event |
|
| Withdrawal by Subject |
|
| PM Dose Sunitinib Malate |
Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | PM Dose Sunitinib Malate | Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. |
| OG002 | Total (Equals AM Plus PM Dose) Sunitinib Malate | Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. |
|
|
|
| Secondary | Number of Participants by Best Confirmed Response Category According to RECIST | Best confirmed response (BCR) defined as best response [confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks. | ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. | Posted | Number | participants | Planned duration on this protocol of up to 1 year |
|
|
|
| Secondary | Number of Participants With Overall Confirmed Objective Disease Response (ORR) | Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. | ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. | Posted | Number | participants | Planned duration on this protocol of up to 1 year |
|
|
|
|
| Secondary | Duration of Stable Disease | Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first. | ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. | Posted | Number | Participants | Planned duration on this protocol of up to 1 year |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first. | ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. | Posted | Number | participants | Planned duration on this protocol of up to 1 year |
|
|
|
|
| Secondary | Time to Tumor Progression (TTP) | TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication. | ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. | Posted | Number | participants | Planned duration on this protocol of up to 1 year |
|
|
|
|
| Secondary | Duration of Tumor Response (DR) [Descriptive Statistics] | DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. | ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. Number of responders (AM=3, PM=5, Total=8) | Posted | Median | Full Range | weeks | Planned duration on this protocol of up to 1 year |
|
|
|
| Secondary | Overall Survival (OS) and One-year Survival [Descriptive Statistics] | Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication. | ITT population (all subjects enrolled that received at least 1 dose of study medication). | Posted | Number | participants | Survival status was collected by telephone contact every 2 months for up to 2 years from study entry. |
|
|
|
|
| Secondary | Score of FACIT-Fatigue Scale | FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for >=10 subjects. | ITT population | Posted | Mean | Standard Deviation | score on scale | Baseline, Day 1 & 15 of each treatment cycle |
|
|
|
| Secondary | Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale) | EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for >=10 subjects. | ITT population. | Posted | Median | Full Range | score on scale | Baseline, Day 1 &15 of each treatment cycle up to 1 year on study |
|
|
|
| Secondary | Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index | EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for >=10 subjects). | ITT population | Posted | Median | Full Range | score on scale | Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study |
|
|
|
| 13 |
| 30 |
| EG001 | PM Dose Sunitinib Malate | Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily. | 12 | 30 |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal wall haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hernia pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Emphysematous cystitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Macrocytosis | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eyelash discolouration | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal wall haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anal pruritus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hernia pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Emphysematous cystitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Breath sounds absent | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Mean cell haemoglobin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Mean cell volume abnormal | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypophosphataemia | 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 |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nodule on extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Formication | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Psychomotor skills impaired | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | 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 |
|
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Capillary fragility | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
Pfizer has the right to review disclosure, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| Stable Disease (SD) |
|
| Progressive disease (PD) |
|
| Not evaluable (NE) |
|
| ORR rate (percentage) |
| 16.7 |
| 95 |
| 5.6 |
| 34.7 |
PR or CR responding tumor measurements confirmed by repeat studies performed at > 4 weeks after the criteria for response first met. |
| No |
| Superiority or Other |
| F distribution | ORR rate (percentage) | 13.3 | 95 | 5.9 | 24.6 | PR or CR responding tumor measurements confirmed by repeat studies performed at > 4 weeks after the criteria for response first met. | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
|
| Kaplan-Meier method |
| median |
| 35.1 |
| 95 |
| 24.4 |
| 51.6 |
| No |
| Superiority or Other |
| 95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks. | Kaplan-Meier method | median | 33.6 | 95 | 24.1 | 49.0 | No | Superiority or Other |
|
| Kaplan-Meier method |
| median |
| 42.1 |
| 95 |
| 26.1 |
| 65.9 |
| No |
| Superiority or Other |
| 95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median. | Kaplan-Meier method | median | 42.1 | 95 | 26.1 | 65.9 | No | Superiority or Other |
|
| 79.7 |
| 95 |
| 60.3 |
| 90.3 |
| No |
| Superiority or Other |
| Kaplan-Meier method | 1 year survival rate | 69.7 | 95 | 56.3 | 79.7 | No | Superiority or Other |
|
| Minimum Post-Baseline Score |
|
|
|