Colorectal Neoplasms
Conditions
Keywords
Phase 1, CRC, SU011248, Sunitinib, FOLFOX, Colorectal cancer, metastatic carcinoma of the colon or rectum
Brief summary
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
Interventions
DRUGsunitinib + mFOLFOX6
37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease. * Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
* Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer. * Prior surgery or investigational agent within 4 weeks prior to study entry. * Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 733 days (the last subject study discontinuation) | Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 1 Day 14 and Cycle 2 Day 1 | Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated. |
| Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 1 Day 14 and Cycle 2 Day 1 | Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated. |
| Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Up to the last subject completed Cycle 24 or individual study discontinuation | Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of \>=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies. |
| Plasma Concentration of Sunitinib | Cycle 1 Day 14 and Cycle 2 Day 1 | Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated. |
| Progression-Free Survival (PFS) | Up to 733 days (the last subject study discontinuation) | Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause. |
| Sunitinib Relative Dose Intensity in the Treatment Arm A | Up to 733 days (the last subject study discontinuation in the Treatment Arm A) | Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Periodn: Cycle (n-1)\*3+1 to n\*3. |
| Sunitinib Relative Dose Intensity in the Treatment Arm B | Up to 384 days (the last subject study discontinuation in the Treatment Arm B) | Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Periodn: Cycle (n-1)\*2+1 to n\*2. |
| Duration of Response (DR) | Up to 733 days (the last subject study discontinuation) | Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter\^2 and l-leucovorin 200 mg/meter\^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter\^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter\^2 on Days 1 and 2 of each cycle. | 6 |
| Treatment Arm B 50 mg/Day (2/2) Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).
FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter\^2 and l-leucovorin 200 mg/meter\^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter\^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter\^2 on Days 1 and 2 of each cycle. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Objective Progression or Relapse | 4 | 3 |
| Overall Study | Surgery | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment Arm A 37.5 mg/Day (4/2) | Treatment Arm B 50 mg/Day (2/2) | Total |
|---|---|---|---|
| Age, Customized 20-44 years | 0 participants | 0 participants | 0 participants |
| Age, Customized 45-64 years | 4 participants | 3 participants | 7 participants |
| Age, Customized >=65 years | 2 participants | 3 participants | 5 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 | 5 participants | 6 participants | 11 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score 1 | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 2 / 6 | 4 / 6 |
Outcome results
Primary
Number of Participants With Adverse Events
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.
Time frame: Up to 733 days (the last subject study discontinuation)
Population: All subjects who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | Any serious adverse evets | 2 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | Sunitinib interruption due to adverse events | 6 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | Any Grade-5 adverse events (= death) | 0 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | mFOLFOX6 interruption due to adverse events | 6 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | Any Grade-3 or -4 adverse evets | 6 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | Sunitinib dose reduction due to adverse events | 1 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | Discontinuation due to adverse events | 1 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | mFOLFOX6 dose reduction due to adverse events | 2 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Number of Participants With Adverse Events | Any adverse events | 6 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | mFOLFOX6 dose reduction due to adverse events | 4 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | Any adverse events | 6 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | Any serious adverse evets | 4 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | Any Grade-3 or -4 adverse evets | 6 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | Any Grade-5 adverse events (= death) | 0 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | Discontinuation due to adverse events | 3 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | Sunitinib interruption due to adverse events | 6 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | mFOLFOX6 interruption due to adverse events | 6 participants |
| Treatment Arm B 50 mg/Day (2/2) | Number of Participants With Adverse Events | Sunitinib dose reduction due to adverse events | 1 participants |
Secondary
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of \>=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.
Time frame: Up to the last subject completed Cycle 24 or individual study discontinuation
Population: All enrolled subjects who 1) had a diagnosis of locally-advanced or metastatic adenocarcinoma of the colon or rectum with measurable disease at baseline; 2) had received at least one dose of the investigational product; and 3) with efficacy data available after administration of the investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Complete Response (CR) | 0 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Partial Response (PR) | 4 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Stable Disease (SD) | 1 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Progressive Disease (PD) | 1 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Indeterminate | 0 participants |
| Treatment Arm A 37.5 mg/Day (4/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Objective Response (CR+PR) | 4 participants |
| Treatment Arm B 50 mg/Day (2/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Indeterminate | 1 participants |
| Treatment Arm B 50 mg/Day (2/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Complete Response (CR) | 0 participants |
| Treatment Arm B 50 mg/Day (2/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Progressive Disease (PD) | 0 participants |
| Treatment Arm B 50 mg/Day (2/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Partial Response (PR) | 4 participants |
| Treatment Arm B 50 mg/Day (2/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Objective Response (CR+PR) | 4 participants |
| Treatment Arm B 50 mg/Day (2/2) | Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Stable Disease (SD) | 1 participants |
Secondary
Duration of Response (DR)
Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.
Time frame: Up to 733 days (the last subject study discontinuation)
Population: Summary statistics were not calculated due to a small number of subjects.
Secondary
Plasma Concentration of Sunitinib
Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Population: Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 1 Day 14, 0 hour post dose | 85.40 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 1 Day 14, 2 hour post dose | 86.15 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 1 Day 14, 6 hour post dose | 93.35 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 1 Day 14, 8 hour post dose | 98.50 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 2 Day 1, 0 hour post dose | 81.70 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 2 Day 1, 2 hour post dose | 87.05 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 2 Day 1, 6 hour post dose | 109.50 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 2 Day 1, 8 hour post dose | 102.00 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib | Cycle 2 Day 1, 24 hour post dose | 81.50 nanogram per milliliter |
Secondary
Plasma Concentration of Sunitinib Active Metabolite (SU012662)
Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Population: Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 1 Day 14, 0 hour post dose | 41.75 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 1 Day 14, 2 hour post dose | 36.90 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 1 Day 14, 6 hour post dose | 43.55 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 1 Day 14, 8 hour post dose | 42.35 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 2 Day 1, 0 hour post dose | 42.65 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 2 Day 1, 2 hour post dose | 36.10 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 2 Day 1, 6 hour post dose | 46.95 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 2 Day 1, 8 hour post dose | 47.10 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of Sunitinib Active Metabolite (SU012662) | Cycle 2 Day 1, 24 hour post dose | 44.85 nanogram per milliliter |
Secondary
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)
Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Population: Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 1 Day 14, 0 hour post dose | 136.25 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 1 Day 14, 2 hour post dose | 123.05 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 1 Day 14, 6 hour post dose | 136.75 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 1 Day 14, 8 hour post dose | 142.35 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 2 Day 1, 0 hour post dose | 132.85 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 2 Day 1, 2 hour post dose | 122.15 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 2 Day 1, 6 hour post dose | 155.45 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 2 Day 1, 8 hour post dose | 156.60 nanogram per milliliter |
| Treatment Arm A 37.5 mg/Day (4/2) | Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) | Cycle 2 Day 1, 24 hour post dose | 132.15 nanogram per milliliter |
Secondary
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.
Time frame: Up to 733 days (the last subject study discontinuation)
Population: Summary statistics were not calculated due to a small number of subjects.
Secondary
Sunitinib Relative Dose Intensity in the Treatment Arm A
Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Periodn: Cycle (n-1)\*3+1 to n\*3.
Time frame: Up to 733 days (the last subject study discontinuation in the Treatment Arm A)
Population: All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 1 (n=6) | 57.1 percent of total planned dose | Standard Deviation 9.3 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 2 (n=5) | 72.4 percent of total planned dose | Standard Deviation 18.5 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 3 (n=5) | 64.3 percent of total planned dose | Standard Deviation 21.1 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 4 (n=4) | 53.6 percent of total planned dose | Standard Deviation 15.4 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 5 (n=3) | 42.9 percent of total planned dose | Standard Deviation 16.5 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 6 (n=2) | 50.0 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 7 (n=2) | 40.5 percent of total planned dose | Standard Deviation 37 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 8 (n=1) | 50.0 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 9 (n=1) | 50.0 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 10 (n=1) | 23.8 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 11 (n=1) | 33.3 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 12 (n=1) | 23.8 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 13 (n=1) | 25.0 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 14 (n=1) | 33.3 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 15 (n=1) | 23.8 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm A | Period 16 (n=1) | 25.0 percent of total planned dose | Standard Deviation 0 |
Secondary
Sunitinib Relative Dose Intensity in the Treatment Arm B
Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Periodn: Cycle (n-1)\*2+1 to n\*2.
Time frame: Up to 384 days (the last subject study discontinuation in the Treatment Arm B)
Population: All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 1 (n=6) | 100.0 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 2 (n=5) | 97.1 percent of total planned dose | Standard Deviation 3.9 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 3 (n=5) | 78.6 percent of total planned dose | Standard Deviation 23.6 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 4 (n=5) | 90.0 percent of total planned dose | Standard Deviation 13.7 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 5 (n=5) | 82.1 percent of total planned dose | Standard Deviation 11 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 6 (n=3) | 73.8 percent of total planned dose | Standard Deviation 26.8 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 7 (n=3) | 75.0 percent of total planned dose | Standard Deviation 25 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 8 (n=3) | 75.0 percent of total planned dose | Standard Deviation 25 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 9 (n=3) | 73.8 percent of total planned dose | Standard Deviation 26.8 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 10 (n=3) | 73.8 percent of total planned dose | Standard Deviation 26.8 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 11 (n=1) | 100.0 percent of total planned dose | Standard Deviation 0 |
| Treatment Arm A 37.5 mg/Day (4/2) | Sunitinib Relative Dose Intensity in the Treatment Arm B | Period 12 (n=1) | 35.7 percent of total planned dose | Standard Deviation 0 |