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This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDD | Experimental |
| |
| 2/1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib, Pemetrexed | Drug | Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation. | End of study (up to individual discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm | Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period. | Up to Cycle 5 (end of study) |
| Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm |
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 | Osakasayama-shi | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20960028 | Derived | Okamoto I, Shimizu T, Miyazaki M, Tsurutani J, Ichikawa Y, Terashima M, Takeda M, Fumita S, Ohki E, Kimura N, Hashimoto J, Nakagawa K. Feasibility study of two schedules of sunitinib in combination with pemetrexed in patients with advanced solid tumors. Invest New Drugs. 2012 Apr;30(2):639-46. doi: 10.1007/s10637-010-9565-5. Epub 2010 Oct 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib 37.5 mg/Day Continuous Daily Dosing | Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle. |
| FG001 | Sunitinib 50 mg/Day Schedule-2/1 | Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib 37.5 mg/Day Continuous Daily Dosing | Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle. |
| BG001 | Sunitinib 50 mg/Day Schedule-2/1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation. | All subjects who received at least 1 dose of the study drug. | Posted | Number | Participants | End of study (up to individual discontinuation) |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib 37.5 mg/Day Continuous Daily Dosing | Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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|
| Sunitinib, Pemetrexed | Drug | Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity. |
|
|
Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period. |
| Up to Cycle 6 |
| Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib. | Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose |
| AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib. | Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose |
| Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib. | Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose |
| Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
| AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct*/kel), where Ct* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile. | Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
| Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Terminal phase elimination half-life was calculated as "natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)". | Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
| Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15 | Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib. | Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose |
| Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants | Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started. | End of study (Up to individual study discontinuation) |
| Global Deterioration of Health Status |
|
| Withdrawal by Subject |
|
Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Score 0: Fully active, able to carry on all pre-disease performance without restriction; Score 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light house work and office work. | Number | Participants |
|
Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle. |
|
|
| Secondary | Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm | Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period. | Full analysis set = defined as "all enrolled patients". n = number of participants assessed for the relative dose intensity in the given period. | Posted | Median | Full Range | percent of total planned dose | Up to Cycle 5 (end of study) |
|
|
|
| Secondary | Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm | Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period. | Full analysis set = defined as "all enrolled patients". n = number of participants assessed for the relative dose intensity in the given period. | Posted | Median | Full Range | percent of total planned dose | Up to Cycle 6 |
|
|
|
| Secondary | Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib. | Participants who provided a plasma concentration data was included in the analysis. | Posted | Mean | Standard Deviation | nanogram/mL | Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib. | Participants who provided a plasma concentration data was included in the analysis. | Posted | Mean | Standard Deviation | nanogram*hour/mL | Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib. | Participants who provided a plasma concentration data was included in the analysis. | Posted | Median | Full Range | hours | Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Participants who provided a plasma concentration data was included in the analysis. | Posted | Mean | Standard Deviation | microgram/mL | Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct*/kel), where Ct* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile. | Participants who provided a plasma concentration data was included in the analysis. | Posted | Mean | Standard Deviation | microgram*hour/mL | Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 | Terminal phase elimination half-life was calculated as "natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)". | Participants who provided a plasma concentration data was included in the analysis. | Posted | Mean | Standard Deviation | hours | Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15 | Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib. | Participants who provided a plasma concentration data was included in the analysis | Posted | Mean | Standard Deviation | nanogram/mL | Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose |
|
|
|
| Secondary | Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants | Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started. | Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST. | Posted | Number | Participants | End of study (Up to individual study discontinuation) |
|
|
|
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Sunitinib 50 mg/Day Schedule-2/1 | Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle. | 1 | 6 | 6 | 6 |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | 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.
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| Title | Measurements |
|---|---|
|
| Cycle 4 (n=4) |
|
| Cycle 5 (n=1) |
|
| Title | Measurements |
|---|---|
|
| Cycle 4 (n=3) |
|
| Cycle 5 (n=3) |
|
| Cycle 6 (n=3) |
|
|
| SU012662: Maximum concentration |
|
| Total drug: Trough concentration |
|
| Total drug: Maximum concentration |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Not Evaluable (NE) |
|
| Objective Response (CR+PR) |
|
| Stable Disease (SD) >=184 days |
|
| Clinical Benefit (CR+PR+SD >=184 days) |
|