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To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response Based on Data Review Committee's Assessment | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response Based on Investigator's Assessment | Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. |
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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 | Anjo | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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The study consisted of 2 cohorts. Cohort 1 enrolled 6 participants. All adverse events in Cohort 1 were evaluated at the end of Cycle 2, and study continuation to Cohort 2 was determined based on the recommendation from the Independent Safety Monitoring Committee. Cohort 2 consisted of 63 participants, including the 6 participants in Cohort 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | SUNITINIB+CAPECITABINE | Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SUNITINIB+CAPECITABINE | Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Objective Response Based on Data Review Committee's Assessment | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. | Full Analysis Set (FAS) is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. | Posted | Number | participants | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. |
|
Up to 28 days after the last administration of the study drug
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SUNITINIB+CAPECITABINE | Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study. |
| 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Sunitinib | Drug | Sunitinib 37.5 mg daily, continuous dosing |
|
| Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. |
| Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment | Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started. | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. |
| Number of Subjects With CBR Based on Investigator's Assessment | Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started. | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. |
| Progression-Free Survival (PFS) | Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first. | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
| Time to Tumor Progression (TTP) | Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression. | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
| Duration of Objective Tumor Response (DR) | Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
| Time to Objective Tumor Response (TTR) | Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
| Overall Survival (OS) | OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death. | A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study. |
| Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant. | Days 14 and 15 of Cycle 1 |
| Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax). The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant. | Days 14 and 15 of Cycle 1 |
| Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration. The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant. | Days 14 and 15 of Cycle 1 |
| AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose. The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant. | Days 14 and 15 of Cycle 1 |
| Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax). 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Day 14 of Cycle 1 |
| Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Day 14 of Cycle 1 |
| AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Day 14 of Cycle 1 |
| t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Day 14 of Cycle 1 |
| Nagoya |
| Aichi-ken |
| Japan |
| Pfizer Investigational Site | Okazaki | Aichi-ken | Japan |
| Pfizer Investigational Site | Toyoake | Aichi-ken | Japan |
| Pfizer Investigational Site | Chiba | Chiba | Japan |
| Pfizer Investigational Site | Matsuyama | Ehime | Japan |
| Pfizer Investigational Site | Fukuoka | Fukuoka | Japan |
| Pfizer Investigational Site | Kure | Hiroshima | Japan |
| Pfizer Investigational Site | Morioka | Iwate | Japan |
| Pfizer Investigational Site | Kyoto | Japan | Japan |
| Pfizer Investigational Site | Kagoshima | Kagoshima-ken | Japan |
| Pfizer Investigational Site | Yokohama | Kanagawa | Japan |
| Pfizer Investigational Site | Osaka | Osaka | Japan |
| Pfizer Investigational Site | Sakai | Osaka | Japan |
| Pfizer Investigational Site | Bunkyo-ku | Tokyo | Japan |
| Pfizer Investigational Site | Koto-ku | Tokyo | Japan |
| Pfizer Investigational Site | Niigata | Japan |
| Results of other clinical study |
|
| Target lesion cannot be evaluated |
|
| Domestic circumstances |
|
| years |
|
| Age, Customized | Number | 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, e.g., light house work, office work. | Number | participants |
|
Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study. |
|
|
|
| Secondary | Number of Participants With Objective Response Based on Investigator's Assessment | Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. | FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. | Posted | Number | participants | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. |
|
|
|
|
| Secondary | Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment | Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started. | FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. | Posted | Number | participants | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. |
|
|
|
|
| Secondary | Number of Subjects With CBR Based on Investigator's Assessment | Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started. | FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. | Posted | Number | participants | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study. |
|
|
|
|
| Secondary | Progression-Free Survival (PFS) | Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first. | FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
|
|
|
| Secondary | Time to Tumor Progression (TTP) | Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression. | FAS is defined as the population of all enrolled patients who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
|
|
|
| Secondary | Duration of Objective Tumor Response (DR) | Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. | FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. Nineteen participants with objective tumor response were analyzed for DR. | Posted | Median | 95% Confidence Interval | months | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
|
|
|
| Secondary | Time to Objective Tumor Response (TTR) | Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response. | FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. Twenty three participants with objective tumor response were analyzed for TTR. | Posted | Median | 95% Confidence Interval | months | Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug. |
|
|
|
| Secondary | Overall Survival (OS) | OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death. | FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication. | Posted | Median | Full Range | months | A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study. |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant. | Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). | Posted | Mean | Standard Deviation | nanogram/milliliter | Days 14 and 15 of Cycle 1 |
|
|
|
| Secondary | Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax). The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant. | Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). | Posted | Median | Full Range | hours | Days 14 and 15 of Cycle 1 |
|
|
|
| Secondary | Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration. The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant. | Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). | Posted | Mean | Standard Deviation | nanogram/milliliter | Days 14 and 15 of Cycle 1 |
|
|
|
| Secondary | AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) | SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose. The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant. | Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). | Posted | Mean | Standard Deviation | nanogram∙hour/milliliter | Days 14 and 15 of Cycle 1 |
|
|
|
| Secondary | Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax). 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). n=Number of participants with analyzable data. | Posted | Median | Full Range | hours | Day 14 of Cycle 1 |
|
|
|
| Secondary | Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Pharmacokinetic parameters are estimated for the initial 6 subjects (Cohort 1). n=Number of subjects with analyzable data. | Posted | Mean | Standard Deviation | nanogram/milliliter | Day 14 of Cycle 1 |
|
|
|
| Secondary | AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Pharmacokinetic parameters are estimated for the initial 6 participants(Cohort 1). n=Number of participants with analyzable data. | Posted | Mean | Standard Deviation | nanogram∙hour/milliliter | Day 14 of Cycle 1 |
|
|
|
| Secondary | t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) | t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil | Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). n=Number of participants with analyzable data. | Posted | Mean | Standard Deviation | hours | Day 14 of Cycle 1 |
|
|
|
| 17 |
| 63 |
| 63 |
| 63 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system 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 |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | 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 |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | 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 bilirubin increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | 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 |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nail disorder | 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 |
|
| 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 |
|
| Blood phosphorus decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal 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.
| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Stable Disease (SD) >= 168 days |
|
| Title | Measurements |
|---|---|
|
| Stable Disease (SD) >= 168 days |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 5-FU (n=4) |
|
| Title | Measurements |
|---|---|
|
| 5-FU (n=4) |
|
| Title | Measurements |
|---|---|
|
| 5-FU (n=3) |
|
| Title | Measurements |
|---|---|
|
| 5-FU (n=3) |
|