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To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib + Gefitinib | Experimental | Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib + Sunitinib | Drug | Until disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tumor Response (TTR) | TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20142724 | Derived | Motzer RJ, Hudes GR, Ginsberg MS, Baum MS, Harmon CS, Kim ST, Chen I, Redman BG. Phase I/II trial of sunitinib plus gefitinib in patients with metastatic renal cell carcinoma. Am J Clin Oncol. 2010 Dec;33(6):614-8. doi: 10.1097/COC.0b013e3181c4454d. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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There were 11 subjects enrolled in Phase 1. Phase 2 included 4 subjects from Phase 1 (37.5 mg sunitinib Cohort) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib Cohort), for a total of 35 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib + Gefitinib | Phase 2 included 4 subjects from Phase 1 (37.5 milligrams (mg) or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib + Gefitinib | Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) | Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. | Intent-to-treat (ITT) = all subjects enrolled in the study that received at least 1 dose of study medication (sunitinib or gefitinib). | Posted | Number | participants | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib + Gefitinib | Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA (v8.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (v8.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter |
| Duration of Response (DR) | DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR). | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer |
| Time to Tumor Progression (TTP) | TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used. | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter |
| Overall Survival (OS) | OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used. | From start of study treatment until death |
| Progression-Free Survival (PFS) | PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used. | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death |
| Probability of Survival at One Year | Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method. | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year |
| VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline | Concentration of VEGF at baseline. | Baseline (Cycle 1, Day 1) |
| VEGF Ratio to Baseline at Each Time Point | VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline). | Baseline to Cycle 3, Day 28 inclusive |
| VEGF-C Concentration at Baseline | Concentration of VEGF-C at baseline. | Baseline (Cycle 1, Day 1) |
| VEGF-C Ratio to Baseline at Each Time Point | VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline). | Baseline to Cycle 3, Day 28 inclusive |
| Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline | Concentration of sVEGFR2 at baseline. | Baseline (Cycle 1, Day 1) |
| sVEGFR2 Ratio to Baseline at Each Time Point | sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline). | Baseline to Cycle 3, Day 28 inclusive |
| Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline | Concentration of sVEGFR3 at baseline. | Baseline (Cycle 1, Day 1) |
| sVEGFR3 Ratio to Baseline at Each Time Point | sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline). | Baseline to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
| Trough Plasma Concentrations (Ctrough) of Sunitinib | prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) |
| Ctrough of SU-012662 (Sunitinib's Metabolite) | prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) |
| Ctrough of Gefitinib | prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) |
| New York |
| New York |
| 10021 |
| United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Withdrawal by Subject |
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| participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
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|
|
| Secondary | Time to Tumor Response (TTR) | TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used. | ITT. Number of participants analyzed = those who had a confirmed response on study. | Posted | Median | 95% Confidence Interval | weeks | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter |
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| Secondary | Duration of Response (DR) | DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR). | ITT. Number of participants analyzed = those who had a response and subsequent progression or death due to any cause while on study. | Posted | Median | Full Range | weeks | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer |
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| Secondary | Time to Tumor Progression (TTP) | TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used. | ITT. Number of participants analyzed = those who progressed on study. | Posted | Median | 95% Confidence Interval | weeks | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter |
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| Secondary | Overall Survival (OS) | OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used. | ITT. Number of participants analyzed = subjects who died. | Posted | Median | Full Range | weeks | From start of study treatment until death |
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| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used. | ITT. Number of participants analyzed = those who progressed or died due to any cause while on study. | Posted | Median | 95% Confidence Interval | weeks | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death |
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| Secondary | Probability of Survival at One Year | Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method. | ITT | Posted | Number | probability | From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year |
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| Secondary | VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline | Concentration of VEGF at baseline. | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | VEGF Ratio to Baseline at Each Time Point | VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Cycle 3, Day 28 inclusive |
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| Secondary | VEGF-C Concentration at Baseline | Concentration of VEGF-C at baseline. | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | VEGF-C Ratio to Baseline at Each Time Point | VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Cycle 3, Day 28 inclusive |
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| Secondary | Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline | Concentration of sVEGFR2 at baseline. | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | sVEGFR2 Ratio to Baseline at Each Time Point | sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Cycle 3, Day 28 inclusive |
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| Secondary | Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline | Concentration of sVEGFR3 at baseline. | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | sVEGFR3 Ratio to Baseline at Each Time Point | sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. | Posted | Mean | Standard Deviation | ratio | Baseline to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) | Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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| Secondary | Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median | Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
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|
|
| Secondary | Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
|
|
|
|
| Secondary | Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
|
|
|
|
| Secondary | Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
|
|
|
|
| Secondary | Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median | Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality). | ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. | Posted | Number | pg/mL | Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive |
|
|
|
|
| Secondary | Trough Plasma Concentrations (Ctrough) of Sunitinib | Pharmacokinetic (PK) = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point. | Posted | Mean | Standard Deviation | ng/mL | prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) |
|
|
|
| Secondary | Ctrough of SU-012662 (Sunitinib's Metabolite) | PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point. | Posted | Mean | Standard Deviation | ng/mL | prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) |
|
|
|
| Secondary | Ctrough of Gefitinib | PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point. | Posted | Mean | Standard Deviation | ng/mL | prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) |
|
|
|
| 11 |
| 35 |
| 35 |
| 35 |
| Myocardial ischaemia | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | Systematic Assessment |
|
| Blood calcium increased | Investigations | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | Systematic Assessment |
|
| Blood pressure increased | Investigations | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007211 | Indoles |
| Title | Measurements |
|---|---|
|
| Cycle 3, Day 1 (n=22) |
|
| Cycle 3, Day 28 (n=20) |
|
| Title | Measurements |
|---|---|
|
| Cycle 3, Day 1 (n=22) |
|
| Cycle 3, Day 28 (n=20) |
|
| Title | Measurements |
|---|---|
|
| Cycle 3, Day 1 (n=22) |
|
| Cycle 3, Day 28 (n=20) |
|
| Title | Measurements |
|---|---|
|
| Cycle 3, Day 1 (n=22) |
|
| Cycle 3, Day 28 (n=20) |
|
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PD, n=4) |
|
| Cycle 2, Day 1 (CR or PR or SD, n=22) |
|
| Cycle 2, Day 1 (PD, n=3) |
|
| Cycle 2, Day 28 (CR or PR or SD, n=21) |
|
| Cycle 2, Day 28 (PD, n=2) |
|
| Cycle 3, Day 1 (CR or PR or SD, n=20) |
|
| Cycle 3, Day 1(PD, n=2) |
|
| Cycle 3, Day 28 (CR or PR or SD, n=20) |
|
| 0.749 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.834 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 1.000 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.332 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PD, n=4) |
|
| Cycle 2, Day 1 (CR or PR or SD, n=22) |
|
| Cycle 2, Day 1 (PD, n=3) |
|
| Cycle 2, Day 28 (CR or PR or SD, n=21) |
|
| Cycle 2, Day 28 (PD, n=2) |
|
| Cycle 3, Day 1 (CR or PR or SD, n=20) |
|
| Cycle 3, Day 1(PD, n=2) |
|
| Cycle 3, Day 28 (CR or PR or SD, n=20) |
|
| 0.286 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.277 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.956 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.278 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PD, n=4) |
|
| Cycle 2, Day 1 (CR or PR or SD, n=22) |
|
| Cycle 2, Day 1 (PD, n=3) |
|
| Cycle 2, Day 28 (CR or PR or SD, n=21) |
|
| Cycle 2, Day 28 (PD, n=2) |
|
| Cycle 3, Day 1 (CR or PR or SD, n=20) |
|
| Cycle 3, Day 1(PD, n=2) |
|
| Cycle 3, Day 28 (CR or PR or SD, n=20) |
|
| 0.227 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.029 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 1.000 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 1.000 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PD, n=4) |
|
| Cycle 2, Day 1 (CR or PR or SD, n=22) |
|
| Cycle 2, Day 1 (PD, n=3) |
|
| Cycle 2, Day 28 (CR or PR or SD, n=21) |
|
| Cycle 2, Day 28 (PD, n=2) |
|
| Cycle 3, Day 1 (CR or PR or SD, n=20) |
|
| Cycle 3, Day 1(PD, n=2) |
|
| Cycle 3, Day 28 (CR or PR or SD, n=20) |
|
| 0.722 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.645 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.140 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.046 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PFS < Median, n=10) |
|
| Cycle 2, Day 1 (PFS >= Median, n=5) |
|
| Cycle 2, Day 1 (PFS < Median, n=9) |
|
| Cycle 2, Day 28 (PFS >= Median, n=5) |
|
| Cycle 2, Day 28 (PFS < Median, n=8) |
|
| Cycle 3, Day 1 (PFS >= Median, n=5) |
|
| Cycle 3, Day 1 (PFS < Median, n=8) |
|
| Cycle 3, Day 28 (PFS >= Median, n=5) |
|
| Cycle 3, Day 28 (PFS < Median, n=6) |
|
| 0.854 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.230 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.067 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.164 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.121 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PFS < Median, n=10) |
|
| Cycle 2, Day 1 (PFS >= Median, n=5) |
|
| Cycle 2, Day 1 (PFS < Median, n=9) |
|
| Cycle 2, Day 28 (PFS >= Median, n=5) |
|
| Cycle 2, Day 28 (PFS < Median, n=8) |
|
| Cycle 3, Day 1 (PFS >= Median, n=5) |
|
| Cycle 3, Day 1 (PFS < Median, n=8) |
|
| Cycle 3, Day 28 (PFS >= Median, n=5) |
|
| Cycle 3, Day 28 (PFS < Median, n=6) |
|
| 0.462 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.423 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.510 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.608 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.121 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PFS < Median, n=10) |
|
| Cycle 2, Day 1 (PFS >= Median, n=5) |
|
| Cycle 2, Day 1 (PFS < Median, n=9) |
|
| Cycle 2, Day 28 (PFS >= Median, n=5) |
|
| Cycle 2, Day 28 (PFS < Median, n=8) |
|
| Cycle 3, Day 1 (PFS >= Median, n=5) |
|
| Cycle 3, Day 1 (PFS < Median, n=8) |
|
| Cycle 3, Day 28 (PFS >= Median, n=5) |
|
| Cycle 3, Day 28 (PFS < Median, n=6) |
|
| 0.020 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 1.000 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.509 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.883 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.582 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (PFS < Median, n=10) |
|
| Cycle 2, Day 1 (PFS >= Median, n=5) |
|
| Cycle 2, Day 1 (PFS < Median, n=9) |
|
| Cycle 2, Day 28 (PFS >= Median, n=5) |
|
| Cycle 2, Day 28 (PFS < Median, n=8) |
|
| Cycle 3, Day 1 (PFS >= Median, n=5) |
|
| Cycle 3, Day 1 (PFS < Median, n=8) |
|
| Cycle 3, Day 28 (PFS >= Median, n=5) |
|
| Cycle 3, Day 28 (PFS < Median, n=6) |
|
| 0.075 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 1.000 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.019 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.124 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.055 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (TTP < Median, n=10) |
|
| Cycle 2, Day 1 (TTP >= Median, n=5) |
|
| Cycle 2, Day 1 (TTP < Median, n=9) |
|
| Cycle 2, Day 28 (TTP >= Median, n=5) |
|
| Cycle 2, Day 28 (TTP < Median, n=8) |
|
| Cycle 3, Day 1 (TTP >= Median, n=5) |
|
| Cycle 3, Day 1 (TTP < Median, n=8) |
|
| Cycle 3, Day 28 (TTP >= Median, n=5) |
|
| Cycle 3, Day 28 (TTP < Median, n=6) |
|
| 0.854 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.230 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.067 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.164 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.121 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (TTP < Median, n=10) |
|
| Cycle 2, Day 1 (TTP >= Median, n=5) |
|
| Cycle 2, Day 1 (TTP < Median, n=9) |
|
| Cycle 2, Day 28 (TTP >= Median, n=5) |
|
| Cycle 2, Day 28 (TTP < Median, n=8) |
|
| Cycle 3, Day 1 (TTP >= Median, n=5) |
|
| Cycle 3, Day 1 (TTP < Median, n=8) |
|
| Cycle 3, Day 28 (TTP >= Median, n=5) |
|
| Cycle 3, Day 28 (TTP < Median, n=6) |
|
| 0.462 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 0.423 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.510 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.608 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.121 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (TTP < Median, n=10) |
|
| Cycle 2, Day 1 (TTP >= Median, n=5) |
|
| Cycle 2, Day 1 (TTP < Median, n=9) |
|
| Cycle 2, Day 28 (TTP >= Median, n=5) |
|
| Cycle 2, Day 28 (TTP < Median, n=8) |
|
| Cycle 3, Day 1 (TTP >= Median, n=5) |
|
| Cycle 3, Day 1 (TTP < Median, n=8) |
|
| Cycle 3, Day 28 (TTP >= Median, n=5) |
|
| Cycle 3, Day 28 (TTP < Median, n=6) |
|
| 0.020 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 1.000 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.509 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.883 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.582 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 1, Day 28 (TTP < Median, n=10) |
|
| Cycle 2, Day 1 (TTP >= Median, n=5) |
|
| Cycle 2, Day 1 (TTP < Median, n=9) |
|
| Cycle 2, Day 28 (TTP >= Median, n=5) |
|
| Cycle 2, Day 28 (TTP < Median, n=8) |
|
| Cycle 3, Day 1 (TTP >= Median, n=5) |
|
| Cycle 3, Day 1 (TTP < Median, n=8) |
|
| Cycle 3, Day 28 (TTP >= Median, n=5) |
|
| Cycle 3, Day 28 (TTP < Median, n=6) |
|
| 0.075 |
| 95 |
| No |
| Superiority or Other |
| Cycle 2, Day 1 | Wilcoxon Rank Sum Test | 1.000 | 95 | No | Superiority or Other |
| Cycle 2, Day 28 | Wilcoxon Rank Sum Test | 0.019 | 95 | No | Superiority or Other |
| Cycle 3, Day 1 | Wilcoxon Rank Sum Test | 0.124 | 95 | No | Superiority or Other |
| Cycle 3, Day 28 | Wilcoxon Rank Sum Test | 0.055 | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Cycle 2, Day 28 (n=27) |
|
| Cycle 3, Day 1 (n=25) |
|
| Cycle 3, Day 28 (n=24) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2, Day 28 (n=27) |
|
| Cycle 3, Day 1 (n=25) |
|
| Cycle 3, Day 28 (n=24) |
|
| Title | Measurements |
|---|---|
|
| Cycle 2, Day 28 (n=27) |
|
| Cycle 3, Day 1 (n=26) |
|
| Cycle 3, Day 28 (n=24) |
|