Non-Small-Cell Lung Cancer
Conditions
Keywords
Erlotinib, ASP2215, NSCLC, Gilteritinib, Non-Small-Cell Lung Cancer
Brief summary
The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.
Detailed description
No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.
Interventions
DRUGGilteritinib
oral
DRUGErlotinib
oral
Sponsors
Astellas Pharma Global Development, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
IInclusion Criteria: * Participant had histologically or cytologically confirmed metastatic or locally advanced, unresectable non-small-cell lung cancer (NSCLC). * Participant had a documented exon 19 deletion or exon 21 L858R EGFR activating mutation. * Participant had received prior treatment with any EGFR tyrosine kinase inhibitor * Participant had Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 at screening. * Participant had adequate organ function. * Female participant must either: * Be of nonchildbearing potential: * Or, if of childbearing potential, 1. Agree not to try to become pregnant during the study and for 45 days after the final study drug administration 2. And had a negative serum pregnancy test at screening 3. And, if heterosexually active, agreed to consistently use 2 forms of highly effective birth control * Male participant and their female spouse/partners who were of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control * Phase 1b Participants only: * Participant was not expected to show a therapeutic response to existing available treatment. * Intervening anticancer treatment subsequent to the EGFR TKI was allowed (but not required). * Additional inclusion criteria for phase 2 Participants only: * Participant had a NSCLC tissue sample obtained after participant developed resistance to EGFR TKI therapy that was available for central testing. * Participant's baseline tumor specimen (obtained after participant developed resistance to EGFR TKI therapy) is T790M negative. * Participant received an EGFR TKI for at least 6 months and progressed on this therapy within the past 28 days. * Participant had not had any intervening anticancer treatment subsequent to the EGFR TKI with the exception of radiotherapy which was allowed if it occurred at least 14 days prior to the first dose of study drug. * Participant had at least 1 measureable lesion (not including any lesion that was irradiated) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Exclusion criteria
* Participant had an ongoing toxicity greater than or equal to grade 3 (NCI CTCAE version 4.03) attributable to prior NSCLC treatment at the time of screening. * Participant received any agent with antitumor activity (other than an EGFR inhibitor, including a T790M inhibitor) including chemotherapy, radiotherapy, immunotherapy, within 14 days prior to the first dose of study drug (palliative radiotherapy is allowed). * Participant received ASP2215 previously. * Participant received blood transfusions or hematopoietic growth factor therapy within 14 days prior to the first dose of study drug. * Participant had a major surgical procedure (other than study-related biopsy) within 14 days prior to the first dose of study drug, or a major surgical procedure was planned to occur during the study. * Participant had active hepatitis B or C or other active hepatic disorder. * Participant t was known to have human immunodeficiency virus (HIV) infection. * Participant had symptomatic central nervous system (CNS) metastasis. Participants with asymptomatic, untreated CNS metastases were allowed. Participants with previously treated and currently asymptomatic CNS metastases were eligible provided they met the following: * Any whole brain radiotherapy (WBRT) was completed at least 2 weeks prior to the first dose of study drug. * Any stereotactic radiosurgery (SRS) was completed at least 1 week prior to the first dose of study drug. * Participant did not require steroids or did not require escalating doses of steroids for at least 2 weeks prior to the first dose of study drug. * Participant had evidence of active infection requiring systemic therapy within 14 days prior to the first dose of study drug. * Participant had uncontrolled hypertension. * Participant had severe or uncontrolled systemic diseases or active bleeding diatheses. * Participant had history of drug-induced interstitial lung disease or any evidence of active interstitial lung disease. * Participant had ongoing cardiac arrhythmia (including atrial fibrillation) that was grade ≥ 2. * Participant currently had Class 3 or 4 New York Heart Association congestive heart failure. * Participant had history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the first dose of study drug. * Participant had history of gastrointestinal ulcer within 28 days prior to the first dose of study drug. * Participant had a history of gastrointestinal bleeding within 90 days prior to the first dose of study drug. * Participant had concurrent corneal disorder or any ophthalmologic condition which makes the participant unsuitable for study participation . * Participant had any condition which made the participant unsuitable for study participation. * Participant had hypokalemia or hypomagnesemia at screening. * Participant had QTcF interval \> 450 ms on 12-lead ECG at screening. * Participant was known to have long QT syndrome. * Participant was taking medication known to prolong the QT interval.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 and Cycle ≥2 (up to 141 days) | — |
| Number of Participants With Adverse Events | From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days) | Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib | 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1 | — |
| Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4 | All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3. |
| AUC24 of Erlotinib | 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1 | — |
| Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib | 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1 | — |
| Tmax of Erlotinib | 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1 | — |
| Ctrough of Erlotinib | Day 8, 15, 22, 28 of cycle 1 | — |
| Objective Response Rate (ORR) in Phase 1b | End of treatment (approximately 4 months) | ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR. |
| Cmax of Erlotinib | 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1 | — |
| Maximum Concentration (Cmax) for Gilteritinib | 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1 | — |
Countries
Japan
Participant flow
Recruitment details
Participants with Epidermal growth factor receptor (EGFR) activating mutation-positive (EGFRm+) advanced NSCLC who have acquired resistance to an EGFR Tyrosine kinase inhibitor (TKI) were enrolled in 4 study sites in Japan.
Pre-assignment details
Eligible participants received gilteritinib in combination with erlotinib 150 mg. At least 3, and no more than 12, dose-limiting toxicity (DLT)-evaluable patients were to be enrolled in a given dose cohort. Dose escalation, cohort expansion or de-escalation decisions were to be guided by a modified toxicity probability interval design.
Participants by arm
| Arm | Count |
|---|---|
| Gilteritinib 120mg + Erlotinib 150mg Gilteritinib was administered in combination with erlotinib orally once daily. | 3 |
| Gilteritinib 80mg+ Erlotinib 150mg Gilteritinib was administered in combination with erlotinib orally once daily. | 7 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Miscellaneous | 0 | 1 |
Baseline characteristics
| Characteristic | Gilteritinib 80mg+ Erlotinib 150mg | Total | Gilteritinib 120mg + Erlotinib 150mg |
|---|---|---|---|
| Age, Continuous | 61.4 year STANDARD_DEVIATION 5.9 | 64.1 year STANDARD_DEVIATION 7.5 | 70.3 year STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 10 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 7 |
| other Total, other adverse events | 3 / 3 | 7 / 7 |
| serious Total, serious adverse events | 2 / 3 | 3 / 7 |
Outcome results
Primary
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.
Time frame: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)
Population: SAF
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Adverse Events | TEAEs leading to death | 0 Participants |
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Adverse Events | Drug-related serious TEAEs | 2 Participants |
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Adverse Events | Drug-related TEAEs | 3 Participants |
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Adverse Events | TEAEs leading to withdrawal of treatment | 2 Participants |
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Adverse Events | Serious TEAEs | 2 Participants |
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Adverse Events | Drug-related TEAEs leading to withdrawal of treat. | 2 Participants |
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Adverse Events | Any TEAEs | 3 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Adverse Events | Drug-related TEAEs leading to withdrawal of treat. | 2 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Adverse Events | Any TEAEs | 7 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Adverse Events | Drug-related TEAEs | 7 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Adverse Events | TEAEs leading to death | 0 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Adverse Events | Serious TEAEs | 3 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Adverse Events | Drug-related serious TEAEs | 2 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Adverse Events | TEAEs leading to withdrawal of treatment | 2 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 and Cycle ≥2 (up to 141 days)
Population: Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs. DLT evaluable set (DES), was a subset of SAF and included participants who were either administered with at least 75% of planned dose during cycle 1 or experienced DLT during cycle 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 | 2 Participants |
| Gilteritinib 120mg + Erlotinib 150mg | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle ≥2 | 0 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 | 2 Participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle ≥2 | 1 Participants |
Secondary
Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Population: Pharmacokinetic Analysis Set (PKAS) consisted of all participants who received at least 1 dose of study drugs for whom sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib | Cycle 1 Day 1 | 2950 h*ng/mL | Standard Deviation 1128 |
| Gilteritinib 120mg + Erlotinib 150mg | Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib | Cycle 1 Day 28 | 12203 h*ng/mL | — |
| Gilteritinib 80mg+ Erlotinib 150mg | Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib | Cycle 1 Day 1 | 1885 h*ng/mL | Standard Deviation 685.6 |
| Gilteritinib 80mg+ Erlotinib 150mg | Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib | Cycle 1 Day 28 | 8342 h*ng/mL | Standard Deviation 3023 |
Secondary
AUC24 of Erlotinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Population: PKAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | AUC24 of Erlotinib | 34580 h*ng/mL | — |
| Gilteritinib 80mg+ Erlotinib 150mg | AUC24 of Erlotinib | 54055 h*ng/mL | Standard Deviation 22962 |
Secondary
Cmax of Erlotinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Population: PKAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Cmax of Erlotinib | 3050 ng/mL | — |
| Gilteritinib 80mg+ Erlotinib 150mg | Cmax of Erlotinib | 3160 ng/mL | Standard Deviation 314.3 |
Secondary
Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib
All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.
Time frame: Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4
Population: PKAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 22 of cycle 1 | 466.3 ng/mL | Standard Deviation 128.2 |
| Gilteritinib 120mg + Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 3 of cycle 1 | 112 ng/mL | Standard Deviation 21.7 |
| Gilteritinib 120mg + Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 28 of cycle 1 | 430 ng/mL | — |
| Gilteritinib 120mg + Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 15 of cycle 1 | 491.7 ng/mL | Standard Deviation 430.5 |
| Gilteritinib 120mg + Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 8 of cycle 1 | 261.3 ng/mL | Standard Deviation 31.66 |
| Gilteritinib 120mg + Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 1 of cycle 1 | 0 ng/mL | Standard Deviation 0 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 28 of cycle 1 | 241.3 ng/mL | Standard Deviation 114.4 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 1 of cycle 3 | 161 ng/mL | Standard Deviation 38.18 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 1 of cycle 4 | 236 ng/mL | Standard Deviation 104.7 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 1 of cycle 1 | 0 ng/mL | Standard Deviation 0 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 3 of cycle 1 | 110.2 ng/mL | Standard Deviation 46.51 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 8 of cycle 1 | 282.9 ng/mL | Standard Deviation 136.7 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 15 of cycle 1 | 397 ng/mL | Standard Deviation 208.9 |
| Gilteritinib 80mg+ Erlotinib 150mg | Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib | Predose on Day 22 of cycle 1 | 414.8 ng/mL | Standard Deviation 186.1 |
Secondary
Ctrough of Erlotinib
Time frame: Day 8, 15, 22, 28 of cycle 1
Population: PKAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 8 of cycle 1 | 1004 ng/mL | Standard Deviation 758.7 |
| Gilteritinib 120mg + Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 15 of cycle 1 | 1427 ng/mL | Standard Deviation 1596 |
| Gilteritinib 120mg + Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 22 of cycle 1 | 942.7 ng/mL | Standard Deviation 116 |
| Gilteritinib 120mg + Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 28 of cycle 1 | 909 ng/mL | — |
| Gilteritinib 80mg+ Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 28 of cycle 1 | 1368 ng/mL | Standard Deviation 1255 |
| Gilteritinib 80mg+ Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 8 of cycle 1 | 1827 ng/mL | Standard Deviation 1392 |
| Gilteritinib 80mg+ Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 22 of cycle 1 | 1999 ng/mL | Standard Deviation 1285 |
| Gilteritinib 80mg+ Erlotinib 150mg | Ctrough of Erlotinib | Predose of Day 15 of cycle 1 | 2098 ng/mL | Standard Deviation 1637 |
Secondary
Maximum Concentration (Cmax) for Gilteritinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Population: PKAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Maximum Concentration (Cmax) for Gilteritinib | Cycle 1 Day 1 | 210.3 ng/mL | Standard Deviation 107.4 |
| Gilteritinib 120mg + Erlotinib 150mg | Maximum Concentration (Cmax) for Gilteritinib | Cycle 1 Day 28 | 637 ng/mL | — |
| Gilteritinib 80mg+ Erlotinib 150mg | Maximum Concentration (Cmax) for Gilteritinib | Cycle 1 Day 1 | 119 ng/mL | Standard Deviation 47.65 |
| Gilteritinib 80mg+ Erlotinib 150mg | Maximum Concentration (Cmax) for Gilteritinib | Cycle 1 Day 28 | 408.3 ng/mL | Standard Deviation 136.6 |
Secondary
Objective Response Rate (ORR) in Phase 1b
ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.
Time frame: End of treatment (approximately 4 months)
Population: ASAT consisted of all participants allocated to treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Objective Response Rate (ORR) in Phase 1b | 0 percentage of participants |
| Gilteritinib 80mg+ Erlotinib 150mg | Objective Response Rate (ORR) in Phase 1b | 0 percentage of participants |
Secondary
Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1
Population: PKAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib | Cycle 1 Day 1, | 3.961 hr | Standard Deviation 0.08221 |
| Gilteritinib 120mg + Erlotinib 150mg | Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib | Cycle 1 Day 28 | 2.00 hr | — |
| Gilteritinib 80mg+ Erlotinib 150mg | Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib | Cycle 1 Day 1, | 3.762 hr | Standard Deviation 0.8109 |
| Gilteritinib 80mg+ Erlotinib 150mg | Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib | Cycle 1 Day 28 | 4.594 hr | Standard Deviation 1.044 |
Secondary
Tmax of Erlotinib
Time frame: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1
Population: PKAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gilteritinib 120mg + Erlotinib 150mg | Tmax of Erlotinib | 2.00 hr | — |
| Gilteritinib 80mg+ Erlotinib 150mg | Tmax of Erlotinib | 2.633 hr | Standard Deviation 1.185 |