Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012377-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Active Comparator |
| |
| Erlotinib + PF-02341066 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) | Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs). | Baseline up to Day 28 |
| Progression-Free Survival (Phase 2) | Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used). | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) | MTD: the combination dose level of PF-02341066 and erlotinib in which 0/6 or 1/6 participants experienced DLT after 28 days of treatment (Cycle 1) with the next higher dose level having at least 2/3 or 2/6 participants with DLT during Cycle 1 of treatment. | Baseline up to 28 days (Cycle 1) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
This study was planned to include 2 phases; phase 1 was a dose escalation safety and pharmacokinetic (PK) study followed by a randomized phase 2 efficacy and safety study. The study was discontinued and phase 2 not started; no participants were enrolled in that phase of the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PF-02341066 (200 mg) and Erlotinib (100 mg) | PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Erlotinib | Drug | For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2 |
|
| PF-02341066 | Drug | For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2 |
|
| PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1) | Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | C1D15 i.e., 15 days of giving crizotinib and erlotinib |
| PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) | Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) | Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15). | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) | Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15). | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| Erlotinib Apparent Oral Clearance (CL/F) (Phase 1) | Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, it is used to characterize erlotinib CL/F after multiple doses in combination with PF-02341066 (Cycle 1 Day 15). | C1D15 i.e., 15 days of giving crizotinib and erlotinib |
| Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) | Ratio of adjusted means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib. | C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib) |
| Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) | Ratio of adjusted means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib. | C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib) |
| Progression-Free Survival (Phase 1) | Time in weeks from phase 1 randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used). | Baseline, every 42 days until disease progression or unacceptable toxicity |
| Duration of Response (Phase 1) | Median duration (50 percent [%]) of tumor response. Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions. | Baseline, every 42 days until disease progression or unacceptable toxicity |
| Percentage of Participants With Objective Response (Phase 1) | Percentage of participants during phase 1 with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. | Baseline, every 42 days until disease progression or unacceptable toxicity |
| Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1) | Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50. | Baseline and Day 50 (Cycle 3, Day 1) |
| Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1) | Baseline and Day 50 (Cycle 3, Day 1) |
| Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2) | Baseline and Day 50 (Cycle 3, Day 1) |
| Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2) | Baseline and Day 50 (Cycle 3, Day 1) |
| Duration of Response (Phase 2) | Median duration (50%) of tumor response. DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity |
| Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2 | Percentage of participants during phase 2 with confirmed CR, confirmed PR or SD according to RECIST 1.1. Also known as Disease Control Rate (DCR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. SD: neither sufficient shrinkage or increase to qualify for PR or PD. | Week 6 and Week 12 |
| Percentage of Participants With Objective Response (Phase 2) | Percentage of participants during phase 2 with objective response based assessment of confirmed CR or confirmed PR according to RECIST (1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity |
| Overall Survival (OS) at Phase 2 | Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. | Baseline until death, up to 20 months |
| European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2 | Phase 2 EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. | Baseline and every 21 days, up to 20 months |
| EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2 | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. | Baseline and every 21 days, up to 20 months |
| Plasma Concentration of PF-02341066 and Erlotinib (Phase 2) | Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2 | Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose |
| Plasma Concentration of Erlotinib (Phase 2) | Plasma concentration of erlotinib when administered as a single agent during phase 2 | Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose) |
| Percentage of Participants With Mutations in Tumor Tissue (Phase 2) | Tumor tissue samples collected for molecular profiling were to be analyzed to assess Kirsten rat sarcoma (KRAS) mutations, mutations, amplification and expression of Epidermal Growth Factor Receptor (EGFR) and c-Met, and echinoderm microtubule-associated protein-like 4-anaplastic large cell receptor kinase (EML4-ALK) fusion in tumors. | Screening |
| Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) | If no more than 1/6 participants presented with a DLT during Cycle 1 at the MTD, then this dose level was considered the RP2D. If >1/6 participants experienced a DLT, then the previous lower level was considered the MTD and RP2D. | Baseline up to 28 days (Cycle 1) |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| University of California, Irvine Medical Center Pharmacy | Orange | California | 92868-3298 | United States |
| University of California, Irving - Medical Center | Orange | California | 92868-3298 | United States |
| University of California Irvin | Orange | California | 92868 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Siteman Cancer Center | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center -West County | Creve Coeur | Missouri | 63141 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110-1094 | United States |
| Washington University, School of Medicine | St Louis | Missouri | 63110 | United States |
| OSU East | Columbus | Ohio | 43205 | United States |
| The Ohio State University James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| James Care in Kenny | Columbus | Ohio | 43221 | United States |
| Cancer Therapy & Research Center @ UTHSCSA | San Antonio | Texas | 78229 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| FG001 | PF-02341066 (150 mg) and Erlotinib (100 mg) | PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-02341066 (200 mg) and Erlotinib (100 mg) | PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. |
| BG001 | PF-02341066 (150 mg) and Erlotinib (100 mg) | PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) | Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs). | DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities) | Posted | Number | participants | Baseline up to Day 28 |
|
|
| |||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (Phase 2) | Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used). | Not analyzed due to phase 2 study termination | Posted | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity |
|
| ||||||||||||||||||||||||||||||||
| Secondary | PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1) | Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | C1D15 i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) | Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) | Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15). | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) | Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15). | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | Erlotinib Apparent Oral Clearance (CL/F) (Phase 1) | Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, it is used to characterize erlotinib CL/F after multiple doses in combination with PF-02341066 (Cycle 1 Day 15). | The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | C1D15 i.e., 15 days of giving crizotinib and erlotinib |
| ||||||||||||||||||||||||||||||
| Secondary | Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) | Ratio of adjusted means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib. | The PK parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | 90% Confidence Interval | Ratio in percentage | C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib) |
| ||||||||||||||||||||||||||||||
| Secondary | Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) | Ratio of adjusted means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib. | The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | 90% Confidence Interval | Ratio in percentage | C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib) |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (Phase 1) | Time in weeks from phase 1 randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used). | not analyzed due to small number of study participants | Posted | Baseline, every 42 days until disease progression or unacceptable toxicity |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (Phase 1) | Median duration (50 percent [%]) of tumor response. Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions. | not analyzed due to small number of responses | Posted | Baseline, every 42 days until disease progression or unacceptable toxicity |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (Phase 1) | Percentage of participants during phase 1 with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. | Response Evaluable Population: all participants enrolled into the Phase 1 portion of the study who receive at least one dose of study medication (either PF-02341066 or erlotinib) and have an adequate baseline tumor assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 42 days until disease progression or unacceptable toxicity |
| ||||||||||||||||||||||||||||||
| Secondary | Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1) | Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50. | The soluble biomarker evaluable population was defined as participants from the safety analysis set of phase 1 who had a soluble protein blood sample taken prior to dosing on Cycle 3 Day 1 and 1 soluble biomarker evaluation after dosing on Cycle 3 Day 1. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline and Day 50 (Cycle 3, Day 1) |
| ||||||||||||||||||||||||||||||
| Secondary | Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1) | Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability | Posted | Baseline and Day 50 (Cycle 3, Day 1) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2) | Not analyzed due to phase 2 study termination | Posted | Baseline and Day 50 (Cycle 3, Day 1) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2) | Not analyzed due to phase 2 study termination | Posted | Baseline and Day 50 (Cycle 3, Day 1) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (Phase 2) | Median duration (50%) of tumor response. DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. | Not analyzed due to phase 2 study termination | Posted | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2 | Percentage of participants during phase 2 with confirmed CR, confirmed PR or SD according to RECIST 1.1. Also known as Disease Control Rate (DCR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. SD: neither sufficient shrinkage or increase to qualify for PR or PD. | Not analyzed due to phase 2 study termination | Posted | Week 6 and Week 12 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (Phase 2) | Percentage of participants during phase 2 with objective response based assessment of confirmed CR or confirmed PR according to RECIST (1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. | Not analyzed due to phase 2 study termination | Posted | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at Phase 2 | Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. | Not analyzed due to phase 2 study termination | Posted | Baseline until death, up to 20 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2 | Phase 2 EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. | Not analyzed due to phase 2 study termination | Posted | Baseline and every 21 days, up to 20 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2 | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. | Not analyzed due to phase 2 study termination | Posted | Baseline and every 21 days, up to 20 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of PF-02341066 and Erlotinib (Phase 2) | Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2 | Not analyzed due to phase 2 study termination | Posted | Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Erlotinib (Phase 2) | Plasma concentration of erlotinib when administered as a single agent during phase 2 | Not analyzed due to phase 2 study termination | Posted | Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Mutations in Tumor Tissue (Phase 2) | Tumor tissue samples collected for molecular profiling were to be analyzed to assess Kirsten rat sarcoma (KRAS) mutations, mutations, amplification and expression of Epidermal Growth Factor Receptor (EGFR) and c-Met, and echinoderm microtubule-associated protein-like 4-anaplastic large cell receptor kinase (EML4-ALK) fusion in tumors. | Not analyzed due to phase 2 study termination | Posted | Screening |
|
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) | MTD: the combination dose level of PF-02341066 and erlotinib in which 0/6 or 1/6 participants experienced DLT after 28 days of treatment (Cycle 1) with the next higher dose level having at least 2/3 or 2/6 participants with DLT during Cycle 1 of treatment. | DLT evaluable population | Posted | Number | mg | Baseline up to 28 days (Cycle 1) |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1) | If no more than 1/6 participants presented with a DLT during Cycle 1 at the MTD, then this dose level was considered the RP2D. If >1/6 participants experienced a DLT, then the previous lower level was considered the MTD and RP2D. | DLT evaluable population | Posted | Number | mg | Baseline up to 28 days (Cycle 1) |
|
|
Up to 28 days after the last dose of study treatment (up to approximately 20 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | PF-02341066 (200 mg) and Erlotinib (100 mg) | PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. | 2 | 7 | 7 | 7 | ||
| EG001 | PF-02341066 (150 mg) and Erlotinib (100 mg) | PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. | 8 | 20 | 19 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Adrenal disorder | Endocrine disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Scotoma | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Breath sounds absent | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Phlebitis superficial | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nail bed infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Local swelling | General disorders | MedDRA v16.1 | Non-systematic Assessment |
|
The sponsor terminated phase 2 of this study; no data was collected during phase 2, leading to phase 2 outcomes not analyzed. The decision was based on strategic considerations regarding the clinical program only; there were no safety concerns.
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 ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial 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 |
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| greater than or equal to (≥) 65 |
|
| Male |
|
|
|
|
|
|
|
|
|
|
|
PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | PF-02341066 (150 mg) and Erlotinib (100 mg) | PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Counts |
|---|
| Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|