Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib (Sutent) | Drug | Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation. | 1, 2, 4, 6, 8, 12, 24 hours postdose |
| Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax). | 1, 2, 4, 6, 8, 12, 24 hours postdose |
| Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax). | 1, 2, 4, 6, 8, 12, 24 hours postdose |
| Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Based on Investigator Assessment | Median time (50 percent [%]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7. | First dose of study treatment until progressive disease |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1000 | Belgium | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
First 12 subjects evaluable for pharmacokinetic (PK) analysis had full PK profile on Cycle 1, Day 1 (C1D1) and C2D1.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib in Combination With Docetaxel | Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib in Combination With Docetaxel | Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2. |
| 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 | Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation. | Evaluable set of subjects for PK analysis is subjects in ITT population who completed sampling for PK profiles for both SU011248 and docetaxel; ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel). | Posted | Median | Full Range | hours | 1, 2, 4, 6, 8, 12, 24 hours postdose |
|
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 | Sunitinib in Combination With Docetaxel | Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (v11.0) | 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 |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D000077143 | Docetaxel |
| 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
|
| Taxotere | Drug | Taxotere 75 mg/m2 iv, once every 3 weeks |
|
| 1, 2, 4, 6, 8, 12, 24 hours postdose |
| Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero. | 0 hour postdose |
| Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters | Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation. | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
| Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters | Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax). | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
| Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters | Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation. | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
| Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters | Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation. | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
| Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters | Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation. | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
| Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters | Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation. | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
| Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters | Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation. | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
| Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment | Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. | First dose of study treatment until at least 4 weeks after confirmed response or partial response |
| Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment | Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study. | First dose of study treatment until at least 24 weeks on study |
| Duration of Tumor Response Based on Investigator Assessment | Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. | Start of first confirmed CR or PR to first confirmed progression or death |
| Milan |
| 20133 |
| Italy |
| Pfizer Investigational Site | Stockholm | 171 76 | Sweden |
| Lack of Efficacy |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax). | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng/mL | 1, 2, 4, 6, 8, 12, 24 hours postdose |
|
|
|
|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax). | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng*hr/mL | 1, 2, 4, 6, 8, 12, 24 hours postdose |
|
|
|
|
| Primary | Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters. | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng*hr/mL | 1, 2, 4, 6, 8, 12, 24 hours postdose |
|
|
| Primary | Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters | Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero. | Evaluable set of subjects for PK analysis; (n) = Number of observations above lower limit of quantification (NALQ). No participants analyzed for SU011248 C1D2 and SU012662 C1D2; standard deviation for Total drug C1D2 confirmed as 0.00 (median, minimum, and maximum = 0.20). | Posted | Mean | Standard Deviation | ng/mL | 0 hour postdose |
|
|
|
| Primary | Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters | Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation. | Evaluable set of subjects for PK analysis | Posted | Median | Full Range | hours | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters | Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax). | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng/mL | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
|
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters | Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation. | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng*hr/mL | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
|
|
|
|
| Secondary | Progression-Free Survival (PFS) Based on Investigator Assessment | Median time (50 percent [%]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7. | ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel). | Posted | Median | 95% Confidence Interval | weeks | First dose of study treatment until progressive disease |
|
|
|
| Secondary | Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment | Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. | ITT; subjects with baseline assessments | Posted | Number | participants | First dose of study treatment until at least 4 weeks after confirmed response or partial response |
|
|
|
|
| Secondary | Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment | Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study. | ITT; subjects with baseline assessments | Posted | Number | participants | First dose of study treatment until at least 24 weeks on study |
|
|
|
|
| Secondary | Duration of Tumor Response Based on Investigator Assessment | Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. | ITT; subgroup of subjects with objective disease response | Posted | Median | 95% Confidence Interval | weeks | Start of first confirmed CR or PR to first confirmed progression or death |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters | Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation. | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng*hr.mL | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
|
|
|
|
| Primary | Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters | Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation. | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng*hr/mL | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
|
|
|
|
| Primary | Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters | Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation. | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | ng*hr/mL | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
|
|
|
|
| Primary | Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters | Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation. | Evaluable set of subjects for PK analysis | Posted | Mean | Standard Deviation | hours | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose |
|
|
|
| 11 |
| 22 |
| 21 |
| 22 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Title | Measurements |
|---|---|
|
| SU012662 C2D3 |
|
| Total drug C1D2 |
|
| Total drug C2D3 |
|
SU012662 C1D2 vs C2D3 |
| Ratio of adjusted geometric means |
| 81.96 |
| 90 |
| 59.76 |
| 112.41 |
Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale. |
| No |
| Superiority or Other |
| Total drug C1D2 vs C2D3 | Ratio of adjusted geometric means | 97.81 | 90 | 80.44 | 118.94 | Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale. | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| SU012662 C2D3 |
|
| Total drug C1D2 |
|
| Total drug C2D3 |
|
| Ratio of adjusted geometric means |
| 81.72 |
| 90 |
| 62.40 |
| 107.04 |
Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale. |
| No |
| Superiority or Other |
| Total drug C1D2 vs C2D3 | Ratio of adjusted geometric means | 100.00 | 90 | 82.95 | 120.56 | Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale. | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| SU012662 C2D1 (n=11) |
|
| Total drug C1D2 (n=12) |
|
| Total drug C1D15 (n=18) |
|
| Total drug 21D1 (n=11) |
|