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This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib | Drug | erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response | Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. |
| Measure | Description | Time Frame |
|---|---|---|
| VEGF-C Ratio to Baseline at Each Timepoint | Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline) | Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
| VEGFR-2 Ratio to Baseline at Each Timepoint |
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 | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23788751 | Derived | Groen HJ, Socinski MA, Grossi F, Juhasz E, Gridelli C, Baas P, Butts CA, Chmielowska E, Usari T, Selaru P, Harmon C, Williams JA, Gao F, Tye L, Chao RC, Blumenschein GR Jr. A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). Ann Oncol. 2013 Sep;24(9):2382-9. doi: 10.1093/annonc/mdt212. Epub 2013 Jun 20. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib + Erlotinib (Original Lead-In) | Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days). |
| FG001 | Sunitinib + Erlotinib (Amended Lead-in) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Lead-In |
|
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| sunitinib | Drug | Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity |
|
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| erlotinib | Drug | erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity |
|
| placebo | Drug | Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity |
|
| From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Time to Tumor Progression (TTP) | TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Duration of Response (DR) | DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Overall Survival (OS) | OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive. | From randomization until death (up to Month 17) |
| Percentage of Participants Surviving at 1 Year | Percentage of participants alive at 1 year after date of first administration of study medication. | From randomization until death (up until Month 17) |
| Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| AUC(0-24) of Sunitinib | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| AUC(0-24) of SU-012662 (Metabolite of Sunitinib) | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| AUC(0-24) of Total Drug (Sunitinib + SU-012662) | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) of Erlotinib | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| Cmax of Sunitinib | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Cmax of SU-012662 (Metabolite of Sunitinib) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Cmax of Total Drug (Sunitinib + SU-012662) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib | AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf]) | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1) |
| AUC(0-inf) for Sunitinib | AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1) |
| AUC(0-inf) for SU-012662 (Metabolite of Sunitinib) | AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1) |
| AUC(0-inf) for Total Drug (Sunitinib + SU-012662) | AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1) |
| Plasma Decay Half-life (t1/2) of Erlotinib | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| Plasma Decay Half-life (t1/2) of Sunitinib | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Erlotinib Clearance at Steady State After Oral Administration (CL/F) | Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| Sunitinib Clearance at Steady State After Oral Administration (CL/F) | Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
| Tmax for Sunitinib | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Tmax for SU-012662 (Metabolite of Sunitinib) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Tmax for Total Drug (Sunitinib + SU-012662) | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
| Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18) |
| Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18) |
| Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18) |
| Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18) |
| Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18) |
| Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18) |
| Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff | Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | Baseline |
| PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff) | PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff) | Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | Baseline |
| PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff) | PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Percentage of Participants With EGFR Gene Copy Number Increase | The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured. | Baseline |
| PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase | PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Percentage of Participants With EGFR Gene Amplification | The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | Baseline |
| PFS in Subgroups That Were Defined by EGFR Gene Amplification | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Percentage of Participants With EGFR Gene Mutation | Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported. | Baseline |
| PFS in Subgroups That Were Defined by EGFR Gene Mutation | PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations | Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported. | Baseline |
| PFS in Subgroups That Were Defined by KRAS Gene Mutation | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms | Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A. | Baseline |
| PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms | OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. | From randomization until death (up to Month 17) |
| Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms | Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A. | Baseline |
| PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms | OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Percentage of Participants by Tumor VEGFR Mutation | Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | Baseline |
| Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts | A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed. | Baseline (Day 1, Cycle 1) |
| Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile | Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | Baseline |
| PFS in Subgroups That Were Defined by RNA Expression Profile | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
| Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score | EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. | Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1 |
| EORTC-QLQ-C30 Lung Cancer Module (LC13) Score | The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. | Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1) |
| Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg) | Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline. | Randomization up until Month 17 |
| Number of Participants With BP Greater Than 200/110 mmHg | Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline. | Randomization up until Month 17 |
| Number of Participants on Anti-hypertensive Medications | Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications. | Randomization to Day 28 of Cycle 18 |
| Plasma Concentration of VEGF-C at Baseline | Baseline (Cycle 1, Day 1) |
| Plasma Concentration of Soluble VEGFR-2 at Baseline | Baseline (Cycle 1, Day 1) |
| Plasma Concentration of Soluble VEGFR-3 at Baseline | Baseline (Cycle 1, Day 1) |
| Plasma Concentration of Soluble KIT (sKIT) at Baseline | Baseline (Cycle 1, Day 1) |
Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)
| Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
| VEGFR-3 Ratio to Baseline at Each Timepoint | Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline) | Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
| sKIT Ratio to Baseline at Each Timepoint | Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline) | Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Pfizer Investigational Site | Mobile | Alabama | 36604 | United States |
| Pfizer Investigational Site | Antioch | California | 94531 | United States |
| Pfizer Investigational Site | Palm Springs | California | 92262-4885 | United States |
| Pfizer Investigational Site | Pleasant Hill | California | 94523 | United States |
| Pfizer Investigational Site | San Leandro | California | 94578 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | City of Saint Peters | Missouri | 63376 | United States |
| Pfizer Investigational Site | Creve Coeur | Missouri | 63141 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110-1094 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7600 | United States |
| Pfizer Investigational Site | Clinton | North Carolina | 28328 | United States |
| Pfizer Investigational Site | Goldsboro | North Carolina | 27534 | United States |
| Pfizer Investigational Site | Wilson | North Carolina | 27893 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Pfizer Investigational Site | Budapest | 1525 | Hungary |
| Pfizer Investigational Site | Törökbálint | 2045 | Hungary |
| Pfizer Investigational Site | Genova | 16132 | Italy |
| Pfizer Investigational Site | Monteforte Irpino, AV | 83024 | Italy |
| Pfizer Investigational Site | Amsterdam | 1066 CX | Netherlands |
| Pfizer Investigational Site | Groningen | 9713 GZ | Netherlands |
| Pfizer Investigational Site | Bydgoszcz | 85-796 | Poland |
| Pfizer Investigational Site | Gdansk | 80-952 | Poland |
| Pfizer Investigational Site | Cluj-Napoca | Cluj | 400015 | Romania |
| Pfizer Investigational Site | Bucharest | Sector 2 | 022328 | Romania |
| Pfizer Investigational Site | Bucharest | 30171 | Romania |
| Pfizer Investigational Site | Santander | Cantabria | 39008 | Spain |
Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B) |
| FG002 | Sunitinib + Erlotinib | Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles. |
| FG003 | Erlotinib + Placebo | Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2 |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib + Erlotinib (Original Lead-In) | Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days). |
| BG001 | Sunitinib + Erlotinib (Amended Lead-in) | Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B) |
| BG002 | Sunitinib + Erlotinib | Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles. |
| BG003 | Erlotinib + Placebo | Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) | PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year. | Full Analysis Set (FA):all participants in randomized phase randomized with study medication assignment designated according to initial randomization, regardless of whether participants actually received study medication or received different medication from what they were randomized. | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
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| Secondary | Percentage of Participants With Objective Response | Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. | FA Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
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| Secondary | Time to Tumor Progression (TTP) | TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
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| Secondary | Duration of Response (DR) | DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02. | FA subset of participants with a confirmed objective response were to be analyzed. As only 3 and 2 responses were observed, duration of response was not analyzed. | Posted | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
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| Secondary | Overall Survival (OS) | OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive. | FA Set | Posted | Median | 95% Confidence Interval | Months | From randomization until death (up to Month 17) |
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| Secondary | Percentage of Participants Surviving at 1 Year | Percentage of participants alive at 1 year after date of first administration of study medication. | FA Set | Posted | Number | Percentage of Participants | From randomization until death (up until Month 17) |
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| Secondary | Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib | Amended Lead-in Cohort Arm A: participants received sunitinib QD for 28 days each cycle (27 days in Cycle 1) and erlotinib QD for 28 days each cycle (7 days in Cycle 1) | Posted | Mean | Standard Deviation | micrograms (mcg)*hour(hr)/milliliter (mL | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | AUC(0-24) of Sunitinib | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib | Amended Lead-In Cohort Arm B: participants received sunitinib for 28 days each cycle (13 days in Cycle 1) and erlotinib QD for 28 days each cycle (26 days in Cycle 1). | Posted | Mean | Standard Deviation | nanograms (ng)*hr/mL | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | AUC(0-24) of SU-012662 (Metabolite of Sunitinib) | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib) | Amended Lead-In Cohort Arm B | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | AUC(0-24) of Total Drug (Sunitinib + SU-012662) | AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662) | Amended Lead-In Cohort Arm B | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Erlotinib | Amended Lead-In Cohort Arm A | Posted | Mean | Standard Deviation | mcg/mL | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | Cmax of Sunitinib | Amended Lead-In Cohort Arm B | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Cmax of SU-012662 (Metabolite of Sunitinib) | Amended Lead-In Cohort Arm B | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Cmax of Total Drug (Sunitinib + SU-012662) | Amended Lead-In Cohort Arm B | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib | AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf]) | Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, AUC(0-inf) could not be accurately estimated. | Posted | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1) |
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| Secondary | AUC(0-inf) for Sunitinib | AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf) | Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated. | Posted | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1) |
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| Secondary | AUC(0-inf) for SU-012662 (Metabolite of Sunitinib) | AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf) | Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated. | Posted | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1) |
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| Secondary | AUC(0-inf) for Total Drug (Sunitinib + SU-012662) | AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf) | Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated. | Posted | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1) |
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| Secondary | Plasma Decay Half-life (t1/2) of Erlotinib | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, t1/2 could not be accurately estimated. | Posted | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | Plasma Decay Half-life (t1/2) of Sunitinib | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, t1/2 could not be accurately estimated. | Posted | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Erlotinib Clearance at Steady State After Oral Administration (CL/F) | Number of participants with calculable data in Original Lead-In; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 24 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm A. | Posted | Mean | Standard Deviation | Liters (L)/hr | Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | Sunitinib Clearance at Steady State After Oral Administration (CL/F) | Number of participants with calculable data in Original Lead-In Cohort; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 48 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm B. | Posted | Mean | Standard Deviation | L/hr | Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib | Amended Lead-In Cohort Arm A | Posted | Median | Full Range | Hours | Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose |
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| Secondary | Tmax for Sunitinib | Amended Lead-In Cohort Arm B | Posted | Median | Full Range | Hours | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Tmax for SU-012662 (Metabolite of Sunitinib) | Amended Lead-In Cohort Arm B | Posted | Median | Full Range | Hours | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Tmax for Total Drug (Sunitinib + SU-012662) | Amended Lead-In Cohort Arm B | Posted | Median | Full Range | Hours | Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose |
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| Secondary | Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | Number of participants analyzed (N)=participants with observations above lower limit of quantification (LLOQ) in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle | Posted | Mean | Standard Deviation | mcg/mL | predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18) |
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| Secondary | Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle | Posted | Mean | Standard Deviation | mcg/mL | predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18) |
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| Secondary | Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle | Posted | Mean | Standard Deviation | ng/mL | predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18) |
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| Secondary | Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle | Posted | Mean | Standard Deviation | ng/mL | predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18) |
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| Secondary | Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle | Posted | Mean | Standard Deviation | ng/mL | predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18) |
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| Secondary | Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized) | Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18. | Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle | Posted | Mean | Standard Deviation | ng/mL | predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18) |
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| Secondary | Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff | Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | FA Set | Posted | Number | Percentage of Participants | Baseline |
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| Secondary | PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff) | PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
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| Secondary | Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff) | Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | FA Set | Posted | Number | Percentage of Participants | Baseline |
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| Secondary | PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff) | PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
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| Secondary | Percentage of Participants With EGFR Gene Copy Number Increase | The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured. | FA Set | Posted | Number | Percentage of Participants | Baseline |
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| Secondary | PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase | PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
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| Secondary | Percentage of Participants With EGFR Gene Amplification | The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | FA Set | Posted | Number | Percentage of Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Subgroups That Were Defined by EGFR Gene Amplification | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With EGFR Gene Mutation | Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported. | FA Set | Posted | Number | Percentage of Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Subgroups That Were Defined by EGFR Gene Mutation | PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations | Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported. | FA Set | Posted | Number | Percentage of Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Subgroups That Were Defined by KRAS Gene Mutation | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms | Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A. | Full Analysis - All Population: all participants from lead-in period and Phase 2 (randomized phase) | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | Per Protocol Caucasian Population: all Caucasian participants in randomized phase who received at least 1 dose of study medication (either erlotinib or blinded medication), with treatment assignments designated according to actual study medication received | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms | OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. | Per Protocol Caucasian Population | Posted | Median | 95% Confidence Interval | Months | From randomization until death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms | Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A. | Full Analysis - All Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | Per Protocol Caucasian Population | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms | OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. | Per Protocol Caucasian Population | Posted | Median | 95% Confidence Interval | Months | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Tumor VEGFR Mutation | Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | Full Analysis - All Population; data were not analyzed | Posted | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts | A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed. | Blood samples were collected; however, because of the small sample size that resulted in a lack of power for statistical testing, no formal statistical analyses were performed. | Posted | Baseline (Day 1, Cycle 1) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | VEGF-C Ratio to Baseline at Each Timepoint | Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline) | FA Set; n equals number of participants with evaluable data at specified cycle | Posted | Median | Full Range | Ratio | Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile | Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. | FA Set | Posted | Number | Percentage of Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | VEGFR-2 Ratio to Baseline at Each Timepoint | Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline) | FA Set; n equals number of participants with evaluable data at specified cycle | Posted | Median | Full Range | Ratio | Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS in Subgroups That Were Defined by RNA Expression Profile | PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02. | FA Set | Posted | Median | 95% Confidence Interval | Weeks | From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | VEGFR-3 Ratio to Baseline at Each Timepoint | Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline) | FA Set; n equals number of participants with evaluable data at specified cycle | Posted | Median | Full Range | Ratio | Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score | EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. | Patient-Reported Outcome (PRO) Analysis Set: participants from the FA Set who had at least 1 EORTC QLQ-C30 or EORTC QLQ Lung cancer (QLQ-LC13) module questionnaire assessment while on treatment; n is number of participants with an assessment at the specified time point. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1 |
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| Other Pre-specified | sKIT Ratio to Baseline at Each Timepoint | Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline) | FA Set; n equals number of participants with evaluable data at specified cycle | Posted | Median | Full Range | Ratio | Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1) |
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| Secondary | EORTC-QLQ-C30 Lung Cancer Module (LC13) Score | The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. | PRO Analysis Set; n is number of participants with an assessment at the specific time point | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1) |
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| Secondary | Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg) | Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline. | Per-Protocol Set: all participants in the Phase 2 portion (randomized) who received at least 1 dose of study medication (either erlotinib or blinded medication) with treatment assignments designated according to actual study medication received | Posted | Number | Participants | Randomization up until Month 17 |
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| Secondary | Number of Participants With BP Greater Than 200/110 mmHg | Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline. | Per-Protocol Set | Posted | Number | Participants | Randomization up until Month 17 |
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| Secondary | Number of Participants on Anti-hypertensive Medications | Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications. | Per Protocol Set; data were not analyzed | Posted | Randomization to Day 28 of Cycle 18 |
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| Secondary | Plasma Concentration of VEGF-C at Baseline | FA Set | Posted | Median | Full Range | picograms (pg)/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | Plasma Concentration of Soluble VEGFR-2 at Baseline | FA Set | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | Plasma Concentration of Soluble VEGFR-3 at Baseline | FA Set | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1, Day 1) |
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| Secondary | Plasma Concentration of Soluble KIT (sKIT) at Baseline | FA Set | Posted | Median | Full Range | pg/mL | Baseline (Cycle 1, Day 1) |
|
|
Not provided
Total number (#) of participants affected/at risk = number of participants with data for summary/number of participants who received at least 1 dose of study treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib + Erlotinib (Original Lead-In) | Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days). | 5 | 13 | 13 | 13 | ||
| EG001 | Sunitinib + Erlotinib (Amended Lead-in) | Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B) | 7 | 17 | 15 | 17 | ||
| EG002 | Sunitinib + Erlotinib | Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles. | 29 | 64 | 60 | 64 | ||
| EG003 | Erlotinib + Placebo | Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles. | 28 | 64 | 61 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Femoral hernia, obstructive | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA | Non-systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic hyperosmolar coma | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Vitamin B12 decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Plantar erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gingival disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Mouth cyst | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Early satiety | General disorders | MedDRA | Non-systematic Assessment |
| |
| Facial pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
| |
| Mucous membrane disorder | General disorders | MedDRA | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral pustule | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory moniliasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA | Non-systematic Assessment |
| |
| Granulocyte count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertrophic osteoarthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Spinal cord oedema | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Haemoglobinuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Peyronie's disease | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Alveolar proteinosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
Due to rounding some percentages will not equal 100%
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@Pfizer.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007211 | Indoles |
Not provided
Not provided
| Global deterioration of health status |
|
| Adverse Event |
|
| Death |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal/other than adverse event |
|
| Study terminated by sponsor |
|
| Other |
|
| Greater than or equal to 65 years |
|
| Unknown or Not Collected |
|
| Male |
|
| Unknown or Not Collected |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
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|
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|
|
|
|
|
|
|
|
| Title | Denominators | Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 22 |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 15 |
|
| Title | Denominators | Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 15 |
|
| Title | Denominators | Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 15 |
|
|
|
| Title | Denominators | Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 22 |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 15 |
|
| Title | Denominators | Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 15 |
|
| Title | Denominators | Categories |
|---|
| Cycle 1, Day 1 |
| |||||
| Cycle 1, Day 15 |
|
|
|
|
|
|
|
|
|
| Participants |
|
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| Participants |
|
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| Participants |
|
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|
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|
|
|
| Counts |
|---|
| Participants |
|
|
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| Participants |
|
|
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|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
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| Participants |
|
|
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|
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|
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