| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 | DLT was defined as any of the following events occurring during the first cycle of treatment and considered at least possibly-related to study medication: any Grade 3 or 4 clinically-relevant non-hematologic and/or hematologic toxicity, delay of more than 2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities. | All enrolled participants who received study treatment and who either experienced DLT during the first cycle, or completed the 1-cycle observation period, were considered evaluable for DLT. Only 2 of the 3 participants were evaluable for DLTs. | Posted | | Number | | participants | | Cycle 1 (28 days) | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Primary | Overall Survival (OS) in Phase 2 | Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. | All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS. | Posted | | | | | | From start of study treatment, collected every 3 months until death (up to 5 years) | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1 | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening. | All enrolled participants in Phase 1 who received at least 1 dose of study medication. | Posted | | Number | | participants | | Baseline up to 28-35 days post last administration of study drug | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 2 | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening. | No participants were analyzed since Phase 2 was not performed. | Posted | | | | | | Baseline up to 28-35 days post last administration of study drug | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Laboratory Abnormalities in Phase 1 | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]). | All participants who received any study treatment. | Posted | | Number | | participants | | Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Laboratory Abnormalities in Phase 2 | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]). | Due to early termination, Phase 2 was not performed and thus no participants were included in this analysis. | Posted | | | | | | Screening; Days 1, 8, 15 of each cycle; up to 28-35 days post last administration of study drug | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Phases 1 and 2 | Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate, weight and body surface area. | All enrolled participants in Phase 1, or all randomized participants in Phase 2, who received at least 1 dose of study medication. Due to early termination of the study, vital sign evaluations were not performed. | Posted | | | | | | Baseline up to 28-35 days after treatment discontinuation | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Worsening QTc Results in Phase 1 | Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4. | All enrolled participants in Phase 1 who had at least 1 ECG assessment after receiving PF-03084014. | Posted | | Number | | participants | | Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Worsening QTc Results in Phase 2 | Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4. | Due to early termination, Phase 2 was not performed and thus no participants were analyzed for this outcome measure. | Posted | | | | | | Screening, Cycle 1 Days 1 and 22, Cycles 2 and 3 Day 1, end of treatment | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1 | AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau, tau=12 hours), and AUC from time 0 to last measured concentration (AUClast). | All treated participants who had at least 1 of the pharmacokinetic (PK) parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*hr/mL) | | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 2 | AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau), and AUC from time 0 to last measured concentration (AUClast). | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | Posted | | | | | | Cycle 1 Day 1 till end of last cycle | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1 | | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 2 | | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | Posted | | | | | | Cycle 1 Day 1 till end of last cycle | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Systemic Clearance (CL) of Nab-paclitaxel in Phase 1 | | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter (L)/hour (hr) | | Cycle 1 Days 1-3, and 15-17 | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Systemic Clearance (CL) of Gemcitabine in Phase 1 | | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter (L)/minute (min) | | Cycle 1 Days 1 and 15 | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Systemic Clearance (CL) of PF-03084014, Nab-P and GEM in Phase 2 | | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | Posted | | | | | | Cycle 1 Day 1 till end of last cycle | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1 | | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | Posted | | Median | Full Range | hours | | PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15. | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 2 | | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | Posted | | | | | | Cycle 1 Day 1 till end of last cycle | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1 | | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel) | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Volume of Distribution at Steady State (Vss) for PF-03084014, Nab-P and GEM in Phase 2 | | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | Posted | | | | | | Cycle 1 Day 1 till end of last cycle | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Plasma Decay Half-life (t1/2) for Nab-P and GEM in Phase 1 | | All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point. | Posted | | Mean | Standard Deviation | hours | | Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel) | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Plasma Decay Half-life (t1/2) for PF-03084014, Nab-P and GEM in Phase 2 | | As Phase 2 was not performed, no participants were analyzed for this outcome measure. | Posted | | | | | | Cycle 1 Day 1 till end of last cycle | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Objective Response (OR) in Phase 1 | Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST). 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 less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 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 non-target disease. No new lesions. | All enrolled participants in Phase 1 who were eligible for enrollment, received study treatment, had measurable disease and adequate baseline assessments, and had at least 1 on-study tumor assessment, were considered evaluable for response. Only 1 participant was evaluable for OR in Phase 1. | Posted | | Number | | participants | | Screening till 28-35 days post last administration of study drug | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Number of Participants With Objective Response (OR) in Phase 2 | Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST). 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 less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 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 non-target disease. No new lesions. | No participants were analyzed for this outcome measure as Phase 2 was not done. | Posted | | | | | | Screening till 28-35 days post last administration of study drug | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Duration of Response (DR) for Phases 1 and 2 | Duration of response (DR) defined as the difference in days between the first date criteria for progression occurred or the participant died due to any cause and the first date that criteria for a PR or CR were met. DR calculated as (months) = (progression/death date - first date of OR + 1) divided by 30.4. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions. | No participants were analyzed for this outcome measure as there were no participants with OR in Phase 1 and Phase 2 was not done. | Posted | | | | | | Baseline, every 8 weeks until disease progression or unacceptable toxicity (up to 5 years) | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | 1-year and 2-year OS in Phase 2 | Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. | All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS. | Posted | | | | | | From start of study treatment, collected every 3 months until death (up to 5 years) | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Progression-free Survival (PFS) in Phase 2 | PFS was defined as the time from the date of first dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date - date of randomization +1) divided by 30.4. | All randomized participants in Phase 2 were to be analyzed for PFS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for PFS. | Posted | | | | | | From start of study treatment, collected every 3 months until death (up to 5 years) | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Brief Pain Inventory-Short Form (BPI-sf) Score - Phase 2 | BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. | As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure. | Posted | | | | | | Day 1 of Cycle 1 and subsequent cycles; end of treatment | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | Change From Baseline in European Quality of Life Questionnaire (EQ-5D) - Phase 2 | EQ-5D: 6-item participant rated questionnaire to assess health-related quality of life in terms of a single utility score. There were 2 components: a Health State Profile and a Visual Analog Scale. Published weights are available that allow for the creation of a single summary score. Overall scores range from 0-1, with low scores representing a higher level of dysfunction. | As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure. | Posted | | | | | | Baseline till end of treatment | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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| Secondary | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30) - 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. | As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure. | Posted | | | | | | Baseline till end of treatment | | | | ID | Title | Description |
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| OG000 | PF-03084014 + Nab-Paclitaxel + Gemcitabine | PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively. |
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