Trial Outcomes & Findings for Study Of Sunitinib With Capecitabine In Breast Cancer (NCT NCT00662025)
NCT ID: NCT00662025
Last Updated: 2013-05-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Results posted on
2013-05-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Objective progression or relapse
|
51
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Results of other clinical study
|
2
|
|
Overall Study
Target lesion cannot be evaluated
|
1
|
|
Overall Study
Domestic circumstances
|
1
|
Baseline Characteristics
Study Of Sunitinib With Capecitabine In Breast Cancer
Baseline characteristics by cohort
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Age Continuous
|
52.9 years
n=5 Participants
|
|
Age, Customized
>=20 years and 44 years >=
|
13 participants
n=5 Participants
|
|
Age, Customized
>=45 years and 64 years >=
|
43 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
7 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Score 0
|
57 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Score 1
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Number of Participants With Objective Response Based on Data Review Committee's Assessment
Total Number of Participants with CR+PR
|
19 participants
|
|
Number of Participants With Objective Response Based on Data Review Committee's Assessment
Complete Response (CR)
|
0 participants
|
|
Number of Participants With Objective Response Based on Data Review Committee's Assessment
Partial Response (PR)
|
19 participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Number of Participants With Objective Response Based on Investigator's Assessment
Total Number of Participants with CR+PR
|
17 participants
|
|
Number of Participants With Objective Response Based on Investigator's Assessment
Complete Response (CR)
|
0 participants
|
|
Number of Participants With Objective Response Based on Investigator's Assessment
Partial Response (PR)
|
17 participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Total Number of Participants with CBR
|
32 participants
|
|
Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Complete Response (CR)
|
0 participants
|
|
Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Partial Response (PR)
|
19 participants
|
|
Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Stable Disease (SD) >= 168 days
|
13 participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Number of Subjects With CBR Based on Investigator's Assessment
Total Number of Participatnts with CBR
|
33 participants
|
|
Number of Subjects With CBR Based on Investigator's Assessment
Complete Response (CR)
|
0 participants
|
|
Number of Subjects With CBR Based on Investigator's Assessment
Partial Response (PR)
|
17 participants
|
|
Number of Subjects With CBR Based on Investigator's Assessment
Stable Disease (SD) >= 168 days
|
16 participants
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Progression-Free Survival (PFS)
|
5.3 months
Interval 4.1 to 5.7
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Time to Tumor Progression (TTP)
|
5.3 months
Interval 4.1 to 5.7
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=19 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.
|
|---|---|
|
Duration of Objective Tumor Response (DR)
|
4.1 months
Interval 2.8 to 5.4
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=23 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.
|
|---|---|
|
Time to Objective Tumor Response (TTR)
|
1.4 months
Interval 1.3 to 1.4
|
SECONDARY outcome
Timeframe: A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.Population: 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.
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=63 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.
|
|---|---|
|
Overall Survival (OS)
|
20.0 months
Interval 17.2 to
The upper confidence interval was not calculated due to immature follow-up data.
|
SECONDARY outcome
Timeframe: Days 14 and 15 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Sunitinib
|
68.7 nanogram/milliliter
Standard Deviation 16.7
|
|
Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662
|
30.8 nanogram/milliliter
Standard Deviation 10.2
|
|
Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Total Drug (Sunitinib+SU012662)
|
99.5 nanogram/milliliter
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: Days 14 and 15 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Sunitinib
|
10 hours
Interval 6.0 to 24.0
|
|
Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662
|
3 hours
Interval 0.0 to 10.0
|
|
Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Total Drug (Sunitinib+SU012662)
|
6 hours
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Days 14 and 15 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Sunitinib
|
87.7 nanogram/milliliter
Standard Deviation 27.6
|
|
Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662
|
33.9 nanogram/milliliter
Standard Deviation 8.43
|
|
Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Total Drug (Sunitinib+SU012662)
|
119 nanogram/milliliter
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: Days 14 and 15 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).
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.
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Sunitinib
|
1886 nanogram∙hour/milliliter
Standard Deviation 524
|
|
AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
SU012662
|
704 nanogram∙hour/milliliter
Standard Deviation 176
|
|
AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)
Total drug (Sunitinib+SU012662)
|
2590 nanogram∙hour/milliliter
Standard Deviation 658
|
SECONDARY outcome
Timeframe: Day 14 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). n=Number of participants with analyzable data.
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
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Capecitabine (n=4)
|
0.75 hours
Interval 0.5 to 2.0
|
|
Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFCR (n=4)
|
1 hours
Interval 1.0 to 2.0
|
|
Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFUR (n=4)
|
1.5 hours
Interval 1.0 to 2.0
|
|
Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5-FU (n=4)
|
1.5 hours
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Day 14 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 subjects (Cohort 1). n=Number of subjects with analyzable data.
Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Capecitabine (n=4)
|
3773 nanogram/milliliter
Standard Deviation 1907
|
|
Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFCR (n=4)
|
5758 nanogram/milliliter
Standard Deviation 2405
|
|
Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFUR (n=4)
|
6885 nanogram/milliliter
Standard Deviation 4130
|
|
Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5-FU (n=4)
|
387 nanogram/milliliter
Standard Deviation 249
|
SECONDARY outcome
Timeframe: Day 14 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 participants(Cohort 1). n=Number of participants with analyzable data.
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
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Capecitabine (n=3)
|
5505 nanogram∙hour/milliliter
Standard Deviation 151
|
|
AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFCR (n=4)
|
13177 nanogram∙hour/milliliter
Standard Deviation 7038
|
|
AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFUR (n=3)
|
12236 nanogram∙hour/milliliter
Standard Deviation 3777
|
|
AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5-FU (n=3)
|
635 nanogram∙hour/milliliter
Standard Deviation 152
|
SECONDARY outcome
Timeframe: Day 14 of Cycle 1Population: Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1). n=Number of participants with analyzable data.
t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil
Outcome measures
| Measure |
SUNITINIB+CAPECITABINE
n=6 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.
|
|---|---|
|
t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
Capecitabine (n=3)
|
0.80 hours
Standard Deviation 0.34
|
|
t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFCR (n=4)
|
1.01 hours
Standard Deviation 0.19
|
|
t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5'-DFUR (n=3)
|
0.73 hours
Standard Deviation 0.05
|
|
t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)
5-FU (n=3)
|
0.77 hours
Standard Deviation 0.06
|
Adverse Events
SUNITINIB+CAPECITABINE
Serious events: 17 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SUNITINIB+CAPECITABINE
n=63 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
1/63 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/63 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
3/63 • 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.
|
|
Gastrointestinal disorders
Ascites
|
1.6%
1/63 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/63 • 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.
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.6%
1/63 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/63 • 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.
|
|
General disorders
Fatigue
|
3.2%
2/63 • 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.
|
|
General disorders
Malaise
|
3.2%
2/63 • 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.
|
|
General disorders
Pyrexia
|
3.2%
2/63 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.2%
2/63 • 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.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.6%
1/63 • 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.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/63 • 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.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.6%
1/63 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
3/63 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/63 • 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.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.6%
1/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
1/63 • 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.
|
|
Vascular disorders
Hypertension
|
3.2%
2/63 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
1.6%
1/63 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
1/63 • 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.
|
Other adverse events
| Measure |
SUNITINIB+CAPECITABINE
n=63 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.8%
15/63 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
73.0%
46/63 • 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.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
14/63 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
93.7%
59/63 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
92.1%
58/63 • 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.
|
|
Endocrine disorders
Hyperthyroidism
|
9.5%
6/63 • 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.
|
|
Endocrine disorders
Hypothyroidism
|
23.8%
15/63 • 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.
|
|
Eye disorders
Dry eye
|
6.3%
4/63 • 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.
|
|
Eye disorders
Eyelid oedema
|
20.6%
13/63 • 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.3%
4/63 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
7/63 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
19.0%
12/63 • 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.
|
|
Gastrointestinal disorders
Cheilitis
|
9.5%
6/63 • 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.
|
|
Gastrointestinal disorders
Constipation
|
25.4%
16/63 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
55.6%
35/63 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
7/63 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.7%
8/63 • 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.
|
|
Gastrointestinal disorders
Gingival bleeding
|
7.9%
5/63 • 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.
|
|
Gastrointestinal disorders
Gingivitis
|
6.3%
4/63 • 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.
|
|
Gastrointestinal disorders
Nausea
|
60.3%
38/63 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
47.6%
30/63 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
28/63 • 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.
|
|
General disorders
Chills
|
6.3%
4/63 • 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.
|
|
General disorders
Face oedema
|
28.6%
18/63 • 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.
|
|
General disorders
Fatigue
|
61.9%
39/63 • 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.
|
|
General disorders
Mucosal inflammation
|
7.9%
5/63 • 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.
|
|
General disorders
Oedema
|
7.9%
5/63 • 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.
|
|
General disorders
Oedema peripheral
|
23.8%
15/63 • 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.
|
|
General disorders
Pyrexia
|
31.7%
20/63 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
30.2%
19/63 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
23.8%
15/63 • 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.
|
|
Infections and infestations
Urinary tract infection
|
6.3%
4/63 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
15.9%
10/63 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
19.0%
12/63 • 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.
|
|
Investigations
Blood bilirubin increased
|
11.1%
7/63 • 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.
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
7/63 • 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.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
20.6%
13/63 • 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.
|
|
Investigations
Blood urine present
|
9.5%
6/63 • 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.
|
|
Investigations
Ejection fraction decreased
|
11.1%
7/63 • 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.
|
|
Investigations
Haemoglobin decreased
|
14.3%
9/63 • 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.
|
|
Investigations
Weight decreased
|
27.0%
17/63 • 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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.9%
5/63 • 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.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
11.1%
7/63 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
65.1%
41/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
7/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.9%
10/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.9%
5/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
7/63 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
5/63 • 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.
|
|
Nervous system disorders
Dizziness
|
9.5%
6/63 • 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.
|
|
Nervous system disorders
Dysgeusia
|
57.1%
36/63 • 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.
|
|
Nervous system disorders
Headache
|
27.0%
17/63 • 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.
|
|
Psychiatric disorders
Insomnia
|
12.7%
8/63 • 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.
|
|
Renal and urinary disorders
Proteinuria
|
12.7%
8/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.7%
8/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
7/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.3%
4/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.9%
5/63 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.3%
4/63 • 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.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
7.9%
5/63 • 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.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
12.7%
8/63 • 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.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
71.4%
45/63 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
18/63 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
20.6%
13/63 • 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.
|
|
Vascular disorders
Haemorrhage
|
7.9%
5/63 • 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.
|
|
Vascular disorders
Hypertension
|
28.6%
18/63 • 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.
|
|
Investigations
Blood phosphorus decreased
|
6.3%
4/63 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
7.9%
5/63 • 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.
|
|
Nervous system disorders
Hypoaesthesia
|
6.3%
4/63 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
4/63 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER