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Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00555620
Enrollment
76
Registered
2007-11-08
Start date
2008-05-31
Completion date
2011-12-31
Last updated
2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Brief summary

The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer

Interventions

DRUGcapecitabine

Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.

DRUGoxaliplatin

Oxaliplatin is given 110mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

DRUGsunitinib malate

sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

DRUGcisplatin

Cisplatin is given 80mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* confirmed diagnosis of stomach cancer * advanced stomach cancer of stage IV * adequate blood chemistry, blood counts and kidney function * willing to participate to study requirements and sign an informed consent document

Exclusion criteria

* prior chemotherapy for the stomach cancer in its advanced stage * excessive toxicities related to prior therapies * pregnant or breastfeeding patients

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)Baseline up to Day 21Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having \>3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery \>14 days.

Secondary

MeasureTime frameDescription
Cmax of CAPDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)—
Cmin of CAPDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Cmin of 5'DFCRDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Cmin of 5'DFURDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Cmin of 5-FUDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)—
Tmax for CAPDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Tmax for 5'DFCRDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Tmax for 5'DFURDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Tmax for 5-FUDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)—
Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)—
t1/2 for CAPDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
t1/2 for 5'DFCRDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
t1/2 for 5'DFURDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
t1/2 for 5-FUDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FUDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FUDay 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAPDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUClast for 5'DFCRDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUClast for 5'DFURDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUClast for 5-FUDay 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Percentage of Participants With Objective ResponseBaseline, Day 21 of every even-numbered cycle up to 15 monthsPercentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Duration of Response (DR)Baseline up to Month 15DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.
Progression-Free Survival (PFS)Baseline up to Month 15PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

South Korea

Participant flow

Participants by arm

ArmCount
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2
Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m\^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m\^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
6
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2
SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
7
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2
SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
15
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2
SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
23
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
3
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m\^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m\^2 oral tablets BID on Days 1-14 of each 21-day cycle.
22
Total76

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyAdverse Event001501
Overall StudyDeath010001
Overall StudyObjective progression or relapse651217316
Overall StudyOther000103
Overall StudyParticipant refused treatment011001
Overall StudyStudy terminated by sponsor001000

Baseline characteristics

CharacteristicSU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Total
Age Continuous55.2 years
STANDARD_DEVIATION 5.8
50.0 years
STANDARD_DEVIATION 12.4
50.9 years
STANDARD_DEVIATION 11.3
54.3 years
STANDARD_DEVIATION 10.1
63.3 years
STANDARD_DEVIATION 11.6
50.1 years
STANDARD_DEVIATION 11.5
52.4 years
STANDARD_DEVIATION 10.9
Sex: Female, Male
Female
0 Participants2 Participants6 Participants6 Participants1 Participants8 Participants23 Participants
Sex: Female, Male
Male
6 Participants5 Participants9 Participants17 Participants2 Participants14 Participants53 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
6 / 67 / 715 / 1523 / 233 / 322 / 22
serious
Total, serious adverse events
1 / 62 / 78 / 158 / 230 / 35 / 22

Outcome results

Primary

Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)

Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having \>3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery \>14 days.

Time frame: Baseline up to Day 21

Population: DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.

ArmMeasureValue (NUMBER)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)1 participants
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)0 participants
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)3 participants
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)2 participants
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)2 participants
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)0 participants
Secondary

Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)

Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.

Time frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) SU012662321 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 254
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) SU011248844 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 155
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) total drug (SU011248+SU012662)1163 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 407
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) SU0112481420 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 379
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) SU012662524 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 219
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) total drug (SU011248+SU012662)1944 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 533
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) SU011248902 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 230
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) total drug (SU011248+SU012662)1230 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 273
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)AUC (0-24) SU012662327 nanogram hours per milliliter (ng*hr/mL)Standard Deviation 64
Secondary

Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU

AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)

Time frame: Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FUCAP (n = 1, 4, 9)25435 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFCR (n = 1, 7, 10)15522 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFUR (n = 1, 6, 10)15522 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5-FU (n = 1, 5, 10)1299 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5-FU (n = 1, 5, 10)353 ng*hr/mLStandard Deviation 141
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FUCAP (n = 1, 4, 9)2663 ng*hr/mLStandard Deviation 452
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFUR (n = 1, 6, 10)4822 ng*hr/mLStandard Deviation 1222
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFCR (n = 1, 7, 10)7087 ng*hr/mLStandard Deviation 1222
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5-FU (n = 1, 5, 10)842 ng*hr/mLStandard Deviation 403
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFCR (n = 1, 7, 10)10091 ng*hr/mLStandard Deviation 2847
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFUR (n = 1, 6, 10)10291 ng*hr/mLStandard Deviation 3675
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FUCAP (n = 1, 4, 9)8865 ng*hr/mLStandard Deviation 6533
Secondary

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FUCAP (n = 1, 4, 10)7480 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFCR (n = 1, 7, 10)9200 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFUR (n = 1, 6, 10)7770 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5-FU (n = 1, 5, 9)386 ng*hr/mL—
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5-FU (n = 1, 5, 9)285 ng*hr/mLStandard Deviation 119
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FUCAP (n = 1, 4, 10)2828 ng*hr/mLStandard Deviation 215
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFUR (n = 1, 6, 10)5703 ng*hr/mLStandard Deviation 1295
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFCR (n = 1, 7, 10)8853 ng*hr/mLStandard Deviation 1648
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5-FU (n = 1, 5, 9)489 ng*hr/mLStandard Deviation 190
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFCR (n = 1, 7, 10)11467 ng*hr/mLStandard Deviation 2476
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU5'DFUR (n = 1, 6, 10)9099 ng*hr/mLStandard Deviation 2288
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FUCAP (n = 1, 4, 10)8069 ng*hr/mLStandard Deviation 3877
Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAPCycle 1, Day 17555 ng*hr/mLStandard Deviation 135
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAPCycle 1, Day 1413532 ng*hr/mLStandard Deviation 16648
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAPCycle 1, Day 12899 ng*hr/mLStandard Deviation 1580
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAPCycle 1, Day 143157 ng*hr/mLStandard Deviation 1171
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAPCycle 1, Day 17373 ng*hr/mLStandard Deviation 4199
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAPCycle 1, Day 148213 ng*hr/mLStandard Deviation 6432
Secondary

AUClast for 5'DFCR

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2AUClast for 5'DFCRCycle 1, Day 112815 ng*hr/mLStandard Deviation 5494
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2AUClast for 5'DFCRCycle 1, Day 148614 ng*hr/mLStandard Deviation 8477
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFCRCycle 1, Day 18028 ng*hr/mLStandard Deviation 1963
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFCRCycle 1, Day 146464 ng*hr/mLStandard Deviation 1377
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFCRCycle 1, Day 111229 ng*hr/mLStandard Deviation 2516
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFCRCycle 1, Day 149776 ng*hr/mLStandard Deviation 2868
Secondary

AUClast for 5'DFUR

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2AUClast for 5'DFURCycle 1, Day 18855 ng*hr/mLStandard Deviation 1761
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2AUClast for 5'DFURCycle 1, Day 148500 ng*hr/mLStandard Deviation 9192
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFURCycle 1, Day 15658 ng*hr/mLStandard Deviation 1237
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFURCycle 1, Day 144829 ng*hr/mLStandard Deviation 1015
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFURCycle 1, Day 18951 ng*hr/mLStandard Deviation 2248
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2AUClast for 5'DFURCycle 1, Day 1410017 ng*hr/mLStandard Deviation 3637
Secondary

AUClast for 5-FU

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2AUClast for 5-FUCycle 1, Day 1355 ng*hr/mLStandard Deviation 27
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2AUClast for 5-FUCycle 1, Day 14688 ng*hr/mLStandard Deviation 802
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2AUClast for 5-FUCycle 1, Day 1291 ng*hr/mLStandard Deviation 95
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2AUClast for 5-FUCycle 1, Day 14350 ng*hr/mLStandard Deviation 129
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2AUClast for 5-FUCycle 1, Day 1506 ng*hr/mLStandard Deviation 200
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2AUClast for 5-FUCycle 1, Day 14854 ng*hr/mLStandard Deviation 390
Secondary

Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)Cycle 1, Day 14800 ng/mLStandard Deviation 863
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)Cycle 1, Day 145500 ng/mLStandard Deviation 5982
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)Cycle 1, Day 13352 ng/mLStandard Deviation 1255
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)Cycle 1, Day 142267 ng/mLStandard Deviation 933
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)Cycle 1, Day 18017 ng/mLStandard Deviation 3692
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)Cycle 1, Day 148036 ng/mLStandard Deviation 3540
Secondary

Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)Cycle 1, Day 14010 ng/mLStandard Deviation 1909
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)Cycle 1, Day 146259 ng/mLStandard Deviation 7381
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)Cycle 1, Day 12891 ng/mLStandard Deviation 1099
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)Cycle 1, Day 142074 ng/mLStandard Deviation 765
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)Cycle 1, Day 17166 ng/mLStandard Deviation 4073
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)Cycle 1, Day 1410082 ng/mLStandard Deviation 5421
Secondary

Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)Cycle 1, Day 1176 ng/mLStandard Deviation 127
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)Cycle 1, Day 14552 ng/mLStandard Deviation 641
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)Cycle 1, Day 1165 ng/mLStandard Deviation 63
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)Cycle 1, Day 14153 ng/mLStandard Deviation 78
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)Cycle 1, Day 1495 ng/mLStandard Deviation 326
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)Cycle 1, Day 14866 ng/mLStandard Deviation 473
Secondary

Cmax of CAP

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of CAPCycle 1, Day 17000 ng/mLStandard Deviation 7354
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmax of CAPCycle 1, Day 1420491 ng/mLStandard Deviation 27098
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of CAPCycle 1, Day 12051 ng/mLStandard Deviation 1109
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmax of CAPCycle 1, Day 141989 ng/mLStandard Deviation 1686
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of CAPCycle 1, Day 111681 ng/mLStandard Deviation 8034
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmax of CAPCycle 1, Day 1416276 ng/mLStandard Deviation 15832
Secondary

Cmin of 5'DFCR

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of 5'DFCRCycle 1, Day 111.1 ng/mLStandard Deviation 15.7
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of 5'DFCRCycle 1, Day 1450.5 ng/mLStandard Deviation 71.4
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFCRCycle 1, Day 113.0 ng/mLStandard Deviation 20.7
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFCRCycle 1, Day 140.00 ng/mLStandard Deviation 0
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFCRCycle 1, Day 155.60 ng/mLStandard Deviation 100.9
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFCRCycle 1, Day 140.00 ng/mLStandard Deviation 0
Secondary

Cmin of 5'DFUR

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of 5'DFURCycle 1, Day 10.0 ng/mLStandard Deviation 0
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of 5'DFURCycle 1, Day 1433.5 ng/mLStandard Deviation 47.4
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFURCycle 1, Day 12.4 ng/mLStandard Deviation 7.1
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFURCycle 1, Day 140.0 ng/mLStandard Deviation 0
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFURCycle 1, Day 134.4 ng/mLStandard Deviation 69
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of 5'DFURCycle 1, Day 140.0 ng/mLStandard Deviation 0
Secondary

Cmin of 5-FU

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of 5-FUCycle 1, Day 10.0 ng/mLStandard Deviation 0
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of 5-FUCycle 1, Day 140.0 ng/mLStandard Deviation 0
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of 5-FUCycle 1, Day 10.0 ng/mLStandard Deviation 0
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of 5-FUCycle 1, Day 140.0 ng/mLStandard Deviation 0
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of 5-FUCycle 1, Day 10.8 ng/mLStandard Deviation 2.5
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of 5-FUCycle 1, Day 140.0 ng/mLStandard Deviation 0
Secondary

Cmin of CAP

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of CAPCycle 1, Day 124.8 ng/mLStandard Deviation 35.1
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Cmin of CAPCycle 1, Day 1432.0 ng/mLStandard Deviation 45.2
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of CAPCycle 1, Day 10.0 ng/mLStandard Deviation 0
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Cmin of CAPCycle 1, Day 140.0 ng/mLStandard Deviation 0
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of CAPCycle 1, Day 10.0 ng/mLStandard Deviation 0
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Cmin of CAPCycle 1, Day 140.0 ng/mLStandard Deviation 0
Secondary

Duration of Response (DR)

DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.

Time frame: Baseline up to Month 15

Population: Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m\^2, CAP 2000 mg/m\^2 reporting group analyzed; all had stable disease during specified time frame

ArmMeasureValue (MEDIAN)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Duration of Response (DR)14.1 months
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Duration of Response (DR)6.3 months
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Duration of Response (DR)10.5 months
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2Duration of Response (DR)5.9 months
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Duration of Response (DR)6.3 months
Secondary

Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)

Time frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax SU01266214.0 nanograms per milliliter (ng/mL)Standard Deviation 11.3
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax SU01124840.1 nanograms per milliliter (ng/mL)Standard Deviation 10.8
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax total drug (SU011248+SU012662)53.9 nanograms per milliliter (ng/mL)Standard Deviation 22.1
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax SU01266223.7 nanograms per milliliter (ng/mL)Standard Deviation 9.9
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax SU01124869.7 nanograms per milliliter (ng/mL)Standard Deviation 17.6
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax total drug (SU011248+SU012662)93.0 nanograms per milliliter (ng/mL)Standard Deviation 24.9
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax SU01124846.5 nanograms per milliliter (ng/mL)Standard Deviation 10.8
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax total drug (SU011248+SU012662)62.4 nanograms per milliliter (ng/mL)Standard Deviation 13.4
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)Cmax SU01266216.6 nanograms per milliliter (ng/mL)Standard Deviation 3.3
Secondary

Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)

Time frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin SU01266211.9 ng/mLStandard Deviation 9.3
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin SU01124829.0 ng/mLStandard Deviation 5.2
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin total drug (SU011248+SU012662)41.6 ng/mLStandard Deviation 15.6
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin SU01266218.7 ng/mLStandard Deviation 7.9
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin SU01124849.2 ng/mLStandard Deviation 13
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin total drug (SU011248+SU012662)68.5 ng/mLStandard Deviation 16.4
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin SU01124830.2 ng/mLStandard Deviation 9.2
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin total drug (SU011248+SU012662)41.8 ng/mLStandard Deviation 11.3
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)Cmin SU01266211.1 ng/mLStandard Deviation 2.6
Secondary

Percentage of Participants With Objective Response

Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: Baseline, Day 21 of every even-numbered cycle up to 15 months

Population: Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).

ArmMeasureValue (NUMBER)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Percentage of Participants With Objective Response16.7 percentage of participants
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Percentage of Participants With Objective Response42.9 percentage of participants
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Percentage of Participants With Objective Response46.7 percentage of participants
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2Percentage of Participants With Objective Response43.5 percentage of participants
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Percentage of Participants With Objective Response0 percentage of participants
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Percentage of Participants With Objective Response45.5 percentage of participants
Secondary

Progression-Free Survival (PFS)

PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Time frame: Baseline up to Month 15

Population: Efficacy analysis subset of population of participants who had an event

ArmMeasureValue (MEDIAN)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Progression-Free Survival (PFS)3.2 months
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Progression-Free Survival (PFS)6.6 months
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Progression-Free Survival (PFS)6.4 months
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2Progression-Free Survival (PFS)8.0 months
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Progression-Free Survival (PFS)2.8 months
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2Progression-Free Survival (PFS)5.5 months
Secondary

t1/2 for 5'DFCR

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for 5'DFCRCycle 1, Day 10.7 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for 5'DFCRCycle 1, Day 140.7 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFCRCycle 1, Day 11.0 hrStandard Deviation 0.4
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFCRCycle 1, Day 141.1 hrStandard Deviation 0.7
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFCRCycle 1, Day 10.8 hrStandard Deviation 0.2
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFCRCycle 1, Day 140.8 hrStandard Deviation 0.1
Secondary

t1/2 for 5'DFUR

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for 5'DFURCycle 1, Day 10.7 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for 5'DFURCycle 1, Day 140.6 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFURCycle 1, Day 11.0 hrStandard Deviation 0.4
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFURCycle 1, Day 141.0 hrStandard Deviation 0.5
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFURCycle 1, Day 10.7 hrStandard Deviation 0.1
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for 5'DFURCycle 1, Day 140.7 hrStandard Deviation 0.1
Secondary

t1/2 for 5-FU

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for 5-FUCycle 1, Day 10.8 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for 5-FUCycle 1, Day 140.6 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for 5-FUCycle 1, Day 11.2 hrStandard Deviation 0.8
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for 5-FUCycle 1, Day 141.1 hrStandard Deviation 0.4
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for 5-FUCycle 1, Day 10.6 hrStandard Deviation 0.1
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for 5-FUCycle 1, Day 140.6 hrStandard Deviation 0.1
Secondary

t1/2 for CAP

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; Number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEAN)Dispersion
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for CAPCycle 1, Day 10.3 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2t1/2 for CAPCycle 1, Day 140.4 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for CAPCycle 1, Day 10.3 hr—
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2t1/2 for CAPCycle 1, Day 140.5 hr—
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for CAPCycle 1, Day 10.4 hrStandard Deviation 0.11
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2t1/2 for CAPCycle 1, Day 140.4 hrStandard Deviation 0.12
Secondary

Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)

Time frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEDIAN)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax SU0126629.0 hour (hr)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax SU0112484.0 hour (hr)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax total drug (SU011248+SU012662)4.0 hour (hr)
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax SU0126628.0 hour (hr)
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax SU0112488.0 hour (hr)
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax total drug (SU011248+SU012662)8.0 hour (hr)
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax SU0112488.0 hour (hr)
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax total drug (SU011248+SU012662)6.0 hour (hr)
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)Tmax SU0126626.0 hour (hr)
Secondary

Tmax for 5'DFCR

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEDIAN)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for 5'DFCRCycle 1, Day 14.3 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for 5'DFCRCycle 1, Day 140.4 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFCRCycle 1, Day 12.0 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFCRCycle 1, Day 143.0 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFCRCycle 1, Day 10.6 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFCRCycle 1, Day 140.5 hr
Secondary

Tmax for 5'DFUR

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEDIAN)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for 5'DFURCycle 1, Day 140.4 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for 5'DFURCycle 1, Day 14.5 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFURCycle 1, Day 143.0 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFURCycle 1, Day 12.0 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFURCycle 1, Day 140.5 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for 5'DFURCycle 1, Day 10.8 hr
Secondary

Tmax for 5-FU

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEDIAN)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for 5-FUCycle 1, Day 14.5 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for 5-FUCycle 1, Day 140.4 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for 5-FUCycle 1, Day 12.0 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for 5-FUCycle 1, Day 143.0 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for 5-FUCycle 1, Day 10.6 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for 5-FUCycle 1, Day 140.5 hr
Secondary

Tmax for CAP

Time frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Population: PK analysis set population; number of participants analyzed (N): participants with evaluable data

ArmMeasureGroupValue (MEDIAN)
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for CAPCycle 1, Day 14.3 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2Tmax for CAPCycle 1, Day 140.3 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for CAPCycle 1, Day 142.0 hr
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2Tmax for CAPCycle 1, Day 12.0 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for CAPCycle 1, Day 140.4 hr
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2Tmax for CAPCycle 1, Day 10.5 hr

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026