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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Have questions about or want more information about A Study of LY3471851 in Participants With Gastric Cancer? Contact us by filling out your information below and we’ll respond to you.

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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development.  Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared.  Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Induction period: Participants received 120 milligrams (mg)  gilteritinib (3 tablets of 40 mg) orally, once daily from day 4 to 17 combined with chemotherapy (idarubicin: 12 mg per square meters per day [mg/m^2/day] on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via intravenous (IV) infusion; in cycles (C) 1 and 2 (1 cycle= 42 days). 
Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from day 1 to 14 combined with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days).
 Duration of infusion was determined by site clinical practice and local package insert in both induction and consolidation periods..
Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 1 to 28 in the maintenance period in C1 to 26 or untill discontinuation criterion is met (1 cycle= 28 days).

Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 4 to 17 in combination with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in the induction period in C1 and 2 (1 cycle= 42 days). 
Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 14 in combination with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in the consolidation period in C1 to 3 (1 cycle= 28 days). 
Duration of infusion was determined based on site clinical practice and the local package insert in both induction and consolidation periods.
Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once a day from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).

Induction period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 8 until blood recovery combined with chemotherapy (idarubicin: 12 mg/m^2/day on days 1 to 3, cytarabine: 100 mg/m^2/day on days 1 to 7) via IV infusion; in C1 and 2. Each cycle was extended until blood recovery was observed. 
Consolidation period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 1 until blood recovery combined with chemotherapy (cytarabine: 1500 mg/m^2, twice daily on days 1, 3, and 5) via IV infusion; in C1 to 3. Each cycle was extended until blood recovery was observed. 
Duration of infusion was based on site clinical practice and the local package insert in both induction and consolidation periods.
Maintenance period: Participants received 120 mg gilteritinib (3 tablets of 40 mg) orally, once daily from days 1 to 28 in the maintenance period in C1 to 26 or a discontinuation criterion is met (1 cycle= 28 days).

The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly diagnosed Acute Myeloid Leukemia (AML) subjects. Phase 1 part also evaluated safety and tolerability and characterized the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluated the PK parameters of cytarabine concomitant with ASP2215.
The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.

A Study of ASP2215 in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia.

This study was composed of Phase 1 part (the dose-evaluation part and the expansion part) and Phase 2 part.

In the dose-evaluation part of Phase 1 part, at least 3 subjects received ASP2215 at each dose (low, middle, and high) for determination of MTD and/or RED.  Treatment of AML in Phase 1 part was composed of 3 periods of therapy: remission induction, consolidation, and maintenance.  The decision of whether or not to proceed to the next dose was made based on the occurrence of DLT during Cycle 1 of the induction period.  

In the expansion part of Phase 1 part, a maximum of 3 subjects received ASP2215 at RED that had been recommended in the dose-evaluation part and the safety was assessed based on the onset of DLTs during Cycle 1 of the induction and consolidation periods.

In Phase 2 part, Subjects received ASP2215 at the recommended dose established in Phase 1 part. The target population was limited to newly diagnosed FLT3-mutated AML.

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Once-daily oral administration on 14 consecutive days in every cycle in each period.

Induction period: Once-daily intravenous injection of 12 mg/m^2 idarubicin on 3 consecutive days.

Induction period: Once-daily intravenous injection of 100 mg/m^2 cytarabine on 7 consecutive days. 
Consolidation period: Twice-daily intravenous injection of 1.5 g/m^2 cytarabine on Days 1, 3, and 5.

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A Phase 1/2 Study of ASP2215 in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia

MTD is defined as the highest dose of ASP2215 at which the posterior mean of the Dose-Limiting Toxicity (DLT) incidence during Cycle 1 of induction therapy is estimated to be closest to 33%.

The sponsor will decide the RED considering the MTD, safety, pharmacokinetics, and efficacy of ASP2215. The final RED will be decided by the sponsor’s responsible person by comprehensively assessing the data obtained from the study, and taking into account the discussion held between the sponsor, the medical expert, the investigator, and the advisor of medical statistics.

A DLT is defined as any Grade ≥ 3 non-hematologic or extramedullary toxicity or any events that require dose reduction of ASP2215 that occur during the DLT assessment period, and that is considered to be possibly, probably, or definitely related to induction or consolidation therapies including the study drugs. The DLT assessment period for making a decision of whether or not to proceed to the next dose is defined as the shorter of the following 2 periods: 39 days from the start of the treatment with ASP2215 in the induction period or days between the start of induction therapy and the start of the first consolidation therapy. For safety assessment during the expansion part, the DLT assessment period includes Cycle 1 of consolidation therapy in addition to the period defined above.

AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA). A treatment-emergent adverse event (TEAE) is defined as an AE observed after starting administration of the investigational product (IP) and within 28 days after the last administration of IP for phase 1 part. An IP-related TEAE is defined as any TEAE with a causal relationship assessed as YES by the investigator.
AE is considered “serious” if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.

Number of participants with potentially clinically significant laboratory values.

Number of participants with potentially clinically significant vital sign values.

CR is defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. There must be no evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood must be ≤ 2%.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Safety Analysis Set (SAF): All participants who received at least 1 dose of study drug were included.

The MTD was defined as the highest dose of gilteritinib at which the posterior mean of the DLT incidence during Cycle 1 of induction therapy was estimated to be closest to 33%.

Dose-Determining Analysis Set (DDAS) Phase 1 part: Participants who received more than 80% of the intended dose of gilteritinib and safety was adequately assessed during DLT assessment period specified in each part were included.

Phase 1 part: Maximum tolerated dose (MTD) of gilteritinib

RED was the recommended dose used in Phase 2 of the study that was decided by the sponsor’s responsible person by comprehensively assessing the data obtained from the study.

Phase 1 part: Recommended expansion dose (RED) of gilteritinib

DLTs were defined as:
Any Grade ≥ 3 non-hematologic or extramedullary toxicity with the following exceptions:
o	Anorexia or fatigue

o	Grade 3 nausea and/or vomiting if participant did not require tube feeding or total parenteral nutrition, or diarrhea if the events did not require or prolong hospitalization that could be managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset.

o	Grade 3 mucositis that resolved to Grade ≤ 2 within 7 days of onset, fever with neutropenia, with or without infection, infection

o	Grade 4 peripheral neutrophil count < 500/cubic millimeters (mm^3)

o	Platelet count < 20,000/mm^3 due to bone marrow hypoplasia

o	Grade ≥ 3 platelet count < 50,000/mm^3 accompanying bleeding

o	Grade 4 platelet count < 25,000/mm^3 requiring platelet transfusion

DLT was assessed until cycle 1 of dose evaluation induction period and until cycle 1 of dose expansion consolidation period.

Phase 1 part: Number of participants with dose limiting toxicities (DLTs) of gilteritinib

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE included both serious and non-serious AEs. TEAE for Phase 1 was defined as an AE observed after the date of first dose until 28 days after the last dose.

Phase 1 part: Number of participants with Treatment Emergent Adverse Events (TEAEs)

Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%.

Participants in the Full Analysis Set (FAS)
Phase 2 part: Participants who received at least 1 dose of study drug and had at least one post-baseline bone marrow assessment were included.

Phase 2 part: Complete remission (CR) rate: Induction Period

Induction Period

Consolidation period

Cmax was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.

Pharmacokinetics Analysis Set (PKAS): Participants who received the study drug, from whom samples for drug concentration measurement were collected for at least 1 time-point after the study drug administration, and from whom drug concentration measurement was obtained were included. PKAS with available data analyzed.

Phase 1 part: Maximum concentration (Cmax) of gilteritinib  concomitant with induction and consolidation chemotherapy

Induction period

Tmax was derived from the PK samples collected.

Phase 1 part: Time to attain Cmax (tmax) of gilteritinib concomitant with induction and consolidation chemotherapy

AUC24 was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.

Phase 1 part: Area under plasma concentration-time curve from time 0 to 24 (AUC24) of gilteritinib concomitant with induction and consolidation chemotherapy

AUClast was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.

Phase 1 part: Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast) of gilteritinib concomitant with induction and consolidation chemotherapy

Induction period: Cycle 1 day 8

Induction period: Cycle 1 day 11

Induction period: Cycle 1 day 17

Consolidation period: Cycle 1 day 6

Consolidation period: Cycle 1 day 15

Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.

Phase 1 part: Plasma trough concentration (Ctrough) of gilteritinib concomitant with induction and consolidation chemotherapy

Induction period: Cycle 1 Day 1

Induction period: Cycle 1 Day 3

Induction period: Cycle 1 Day 8

Consolidation period: Cycle 1 Day 2

Consolidation period: Cycle 1 Day 6

Phase 1 part: Plasma trough concentration of cytarabine concomitant with gilteritinib with induction and consolidation period

Induction Period: Cycle 1 Day 15

Induction Period: Cycle 1 Day 21

Consolidation Period: Cycle 1 Day 8

Consolidation Period: Cycle 1 Day 15

Ctrough is the plasma concentration prior to drug administration.

Phase 2 part: Plasma trough concentration of gilteritinib concomitant with induction and consolidation chemotherapy

Overall survival (OS) was defined as the time from the date of first dose of day 1 to the date of death due to any cause. Participants still alive or lost to follow up was censored at the time they were last known to be alive. Kaplan-Meier (KM) estimate was used for analysis.

Phase 2 part: Overall survival (OS)

Event-free survival (EFS): time from date of first dose of study regimen until date of documented relapse, treatment failure or death from any cause, whichever occurred first. KM estimate was used for analysis. Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%. Treatment failure: participants who failed to achieve composite complete remission (CRc) or who discontinued treatment due to “lack of efficacy” without previous response. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3). CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). CR: defined in outcome measure #5.

Phase 2 part: Event Free Survival (EFS)

Relapse-free survival (RFS): time from date of achievement of first CRc until relapse or death from any cause. KM estimate was used for analysis.

Relapse: reappearance of leukemic blasts in peripheral blood (>2%)/≥ 5% blasts in bone marrow aspirate (BMA)/reappearance of significant numbers of peripheral blasts and an increase in percentage of blasts in BMA to > 25%.

CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi).

CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3).

CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). 

CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%.

Phase 2 part:  Relapse Free Survival (RFS)

Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%.

Phase 2 part: CR rate after Consolidation and Maintenance Period

Percentage of CR without MRD was reported. CR rate without MRD after each treatment therapy was defined similarly as CR rate after each treatment therapy. Responders achieve that the best response is CR and MRD status was negative. 
CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%.

Phase 2 part: CR rate without minimal residual disease (MRD) after each treatment therapy period

Percentage of participants with CRh was reported. CRh was defined as a condition at the post baseline visit, having bone marrow blasts < 5%, partial hematologic recovery neutrophil count≥ 500/mm^3 and platelet count ≥ 50,000/mm^3, no evidence of extramedullary leukemia and could be classified as CR. The blast counts in peripheral blood was ≤ 2%.

Phase 2 part: CR with partial hematological recovery (CRh) rate after each treatment therapy period

Percentage of participants with CRc was reported. CRc: rate of all complete & incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi).

CRp: met all CR criteria at post-baseline visit, except unrecovered platelet count (< 100,000/mm^3).

CRi: met all CR criteria at post-baseline visit, except unrecovered neutrophil count (< 1,000/mm^3). 

CR: morphologically leukemia-free state at post-baseline visit, having neutrophil count of ≥ 1,000/mm^3 and platelet count of ≥ 100,000/mm^3, bone marrow blasts < 5%. No evidence of Auer rods & extramedullary leukemia. Blast counts in peripheral blood was ≤ 2%.