| Primary | Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1 | DSN was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of less than (<) 0.5 × 10^9 cells/liter (L) observed between Day 1 Cycle 1 and the end of Cycle 1 to the date of the first ANC value greater than or equal to (>=) 0.5 × 10^9/L that met the following: (1) occurred after the ANC value of < 0.5 × 10^9 cells/L and (2) no other ANC values < 0.5 × 10^9 cells/L occurred between this day and the end of Cycle 1. Severe neutropenia (SN) was set to zero for participants who did not experience severe (Grade 4) neutropenia in Cycle 1, including those who were randomized but never treated. | The ITT analysis set included all randomized participants. | Posted | | Mean | Standard Deviation | days | | From randomization to the end of Cycle 1 (Each cycle= 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) | Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001± 2.2
- OG0012± 3.5
- OG0021± 2.6
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Duration of SN in Cycle 1 in Group 3 vs Group 1. | Analysis of covariance (ANCOVA) | | 0.7048 | A Hochberg-based gatekeeping procedure was used to control the global family-wise error rate across the multiple null hypotheses in the strong sense at a 1-sided 0.025 level. | Mean difference | 0.3 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -0.8 | 1.5 | | | | | Superiority | | | |
|
| Primary | Number of Participants With Severe (Grade 4) Neutropenia (SN) | Number of participants with Grade 4 SN was a binary variable. If a participants had at least 1 ANC value < 0.5 ×10^9/L during the treatment period, the participants was assigned as "yes" to the occurrence of SN. Otherwise, it was "no". | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | BOR was defined as the best response across all time points (RECIST v1.1). The best overall response was determined once all the data for the participant is known. Each participant has been assigned one of the following categories (RECIST 1.1): complete response (CR): disappearance of all target lesions; partial response (PR): >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progression disease (PD): >= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study); stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD); NE: not evaluable and missing. | The response-evaluable (RE) analysis set included all participants who were in the modified intent-to-treat (mITT) analysis set, had measurable disease (target lesions [TLs]) at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan. | Posted | | Count of Participants | | Participants | | From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). |
|
| Secondary | Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator | DOR is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Participants who do not experience PD or death was censored at the last tumor assessment date. 95% Confidence Interval (CI) was calculated using the Kaplan-Meier method. | The RE analysis set included all participants who were in the mITT analysis set, had measurable disease TLs at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | |
|
| Secondary | Overall Survival (OS) | Overall survival was defined as the time (months) from date of randomization to the date of death due to any cause. Participants who do not die during the study were censored at the date last known to be alive. The OS was calculated using Kaplan-Meier method. | The ITT analysis set included all randomized participants. | Posted | | Median | 95% Confidence Interval | months | | From date of randomization to date of death due to any cause, assessed up to a maximum of 1120 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) | |
|
| Secondary | Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator | PFS was defined as the time (months) from date of randomization until date of documented PD or death due to any cause, whichever comes first. PD: >= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study). The PFS was calculated using Kaplan-Meier method. | The ITT analysis set included all randomized participants. | Posted | | Median | 95% Confidence Interval | months | | From date of randomization until the occurrence of disease progression, death due to any cause or a censoring event, assessed up to a maximum of 875 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Relative Dose Intensity of Gemcitabine and Carboplatin | Relative dose intensity was defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity was defined as the cumulative planned dose through the study divided by (number of cycles × 3 weeks). Relative dose intensity (%) was calculated as: for gemcitabine (100 * [Dose intensity (mg/m2/week) / (2000/3 (mg/m2/week)]); for carboplatin (100 * [Dose intensity (AUC/week)/ (4/3) (AUC/week)]) and for trilaciclib (100 * [Dose intensity (mg/m2/week)/ (480 /3 (mg/m2/week)] for Group 2 and 100 * [Dose intensity (mg/m2/week) / (960 /3 (mg/m2/week)] for Group 3). | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | percentage of dose | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Duration of Exposure | Duration of exposure (days) = First dose date of study drug from the last cycle - first dose date of study drug + 21. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Median | Full Range | days | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) | |
|
| Secondary | Number of Cycles Participants Received Treatment in Each Treatment Arm | Participants were considered to have started a cycle if they have received at least 1 dose of any study drug. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | number of cycles | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Cumulative Dose of Gemcitabine | Cumulative dose: Sum of the total doses by cycle administered to a participant in the duration of exposure, i.e. total number of cycles received (milligram per meter square [mg/m^2]). | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | mg/m^2 | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Cumulative Dose of Carboplatin | Cumulative dose: Sum of the total doses by cycle (AUC) administered to a participant in the duration of exposure, i.e. total number of cycles received (in total prescribed AUC). | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | AUC (mg/mL/min) | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Trilaciclib | The observed peak plasma concentration was determined from the plasma concentration-versus time data. | The pharmacokinetic (PK) analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported. | Posted | | Mean | Standard Deviation | ng/mL | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Day 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 |
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib | AUC0-t was calculated with the linear/log-trapezoidal method, which uses linear interpolation between data points to calculate the AUC. The linear/log-trapezoidal method will be employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method will be used for those arising from decreasing concentrations. | The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported. | Posted | | Mean | Standard Deviation | hour* nanogram per milliliter (h*ng/mL) | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Day 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Terminal Elimination Half-Life (t1/2) of Trilaciclib | t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve, the actual body exposure to drug after administration of a dose of the drug ( in mg*h/L). | The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported. | Posted | | Median | Full Range | hours | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Day 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Gemcitabine | The observed peak plasma concentration was determined from the plasma concentration-versus time data. | The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Day 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine | AUC0-t was calculated with the linear/log-trapezoidal method. | The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | hour*microgram per milliliter (h*mcg/mL) | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Day 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Terminal Elimination Half-Life (t1/2) of Free Carboplatin | t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve. | The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | hours | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Clearance (CL) of of Free Carboplatin | Clearance after intravenous infusion administration was calculated as: CL=Dose/AUC0-inf. AUC0-inf was calculated as: AUC0-inf=AUClast+Clast/lambdaz where Clast is the last quantifiable concentration in the terminal elimination phase. | The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Liter/hour (L/h) | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Volume of Distribution at Steady State (Vss) of Free Carboplatin | Vss was the volume of distribution at steady state of free carboplatin was reported. | The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Liter | | Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Number of Participants With Grade 3 and 4 Hematologic Toxicities | Hematologic toxicities events were defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for >= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 hematologic toxicities during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Number of Participants With Grade 3 or 4 Thrombocytopenia | Hematologic toxicities events are defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for >= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 thrombocytopenia was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 thrombocytopenia during the treatment period, the participant was assigned as "Yes" to the occurrence of Grade 3 and 4 thrombocytopenia; otherwise, it was "No". If a participant did not have an event, the value of 0 was assigned to that participant. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Major Adverse Hematologic Event (MAHE) Rate | MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelosuppression into a single endpoint by summing of the total number of events across a set of pre-specified components.The individual components for MAHE were all-cause hospitalizations, all-cause dose reductions, febrile neutropenia, prolonged severe neutropenia (duration > 5 days), RBC transfusion and platelet transfusion. Event rate for MAHE was calculated as the number of events/durations of treatment period divided by 7 days/1 week. | The ITT analysis set included all randomized participants. | Posted | | Number | | event rate per week | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Number of Participants With Febrile Neutropenia (FN) | The criterion for identifying FN was if the PT was "FEBRILE NEUTROPENIA" the occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events >=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 |
|
| Secondary | Number of Participants With Infection SAEs | Number of participants with infection SAEs during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events >=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion for identifying the proper infection SAE records was as follows: If the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) takes value "INFECTIONS AND INFESTATIONS," and the AE was a serious event. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Number of Participants With Red Blood Cell (RBC) Transfusions On/After Week 5 (Day 35) | Each RBC transfusion with a unique start date on/after 5 weeks on study during the treatment period was defined as a separate event. Occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if the total number of events >=1 was observed and "No" for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | From Day 35 through the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 508 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Number of Participants With Platelet Transfusions | Each platelet transfusion with a unique start date during the treatment period was defined as a separate event. The occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if the total number of events >=1 was observed and No for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | |
|
| Secondary | Number of Participants With Granulocyte Colony-stimulating Factor (G-CSF) Administration | The criterion for selecting proper records is as follows: If the chemical subgroup from the World Health Organization-Drug Dictionary (WHO-DD) takes value "COLONY STIMULATING FACTOR," the medication was classified as G-CSF. The occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if the total number of events >=1 was observed and "No" for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Number of Participants With Erythropoiesis Stimulating Agent (ESA) Administration | The occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if total number of events >=1 was observed, "No" for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (i.e., TEXT4 for CODE4) takes value "OTHER ANTIANEMIC PREPARATIONS", the medication was classified as ESAs. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Number of Participants With Intravenous Antibiotics Use | The criteria for identifying an IV antibiotic administration event was (1) if the Therapeutic subgroup from WHO-DD version takes value "ANTIBACTERIALS FOR SYSTEMIC USE", and (2) the route of medication was "intravenous" or the route was "other" with the detailed specification as "IVPB". The occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if total number of events >=1 was observed, "No" for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. | The ITT analysis set included all randomized participants. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Day 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | All-cause Dose Reductions, Event Rate (Per Cycle) | Dose reductions were not permitted for trilaciclib. Dose reductions for gemcitabine or carboplatin were collected on the dosing page. No more than 3 dose modifications for toxicity in total were allowed for any participant. All dose reductions were counted as a separate event. Discontinuations of an individual component of the chemotherapy regimen were counted as a dose reduction If the participant continued the other chemotherapy drug as a monotherapy. Event rate was calculated as the total number of cycles with an event divided by the total number of cycles. | The ITT analysis set included all randomized participants. | Posted | | Number | | event rate per cycle | | During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Dose Modifications: Number of Participants With Cycle Delays | Dose modifications was summarized for each study drug based on number of cycles received during the treatment period. If the participant was unable to start a new cycle at that next visit, then the cycle is delayed, the reason entered, and the question was asked again at the next visit until the participant either starts a new cycle or discontinues treatment. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
|
| Secondary | Dose Modifications - Number of Participants With Skipped Doses | Dose modifications was summarized for each study drug based on skipped doses not received during the treatment period. Primary reasons for skipped doses included toxicity, investigator decision and administrative reasons (e.g., holidays). | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 |
|
| Secondary | Dose Modifications: Number of Participants With Any Dose Interruptions | Dose interruptions was defined as interruption of infusion, regardless of whether the study drug was continued after the interruption. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
|
| Secondary | Dose Modifications - Number of Participants With Dose Reductions | Dose (mg/m2) reductions were not permitted for trilaciclib. Dose reductions for carboplatin and gemcitabine were determined by comparing the planned dose on the respective drug administration pages between the current cycle and the previous cycle. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | | OG002 |
|
| Other Pre-specified | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An Adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. Any AE that started on or after the first dose of study drugs was included as a TEAE. A Serious AE was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) and regardless of causality that met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. TEAEs included serious and non-serious TEAEs. | The safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 1116 days | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | | OG001 |
|