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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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Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under “Sponsor Specific Details for Astellas."

Participants received 120 milligrams (mg) giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 420 mg adminstered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 535 days for gilteritinib and 112 days for atezolizumab).

Participants received 120 mg giltertinib (3 tablets of 40 mg) orally, once a day in continuous 28-day cycles in combination with atezolizumab 840 mg administered by intravenous infusion (over 60 minutes) once every 2 weeks of 28-day cycle until the participant no longer received clinical benefit from therapy, unacceptable toxicity occurred or the participant met a treatment discontinuation criterion (Maximum treatment duration was 126 days for gilteritinib and 70 days for atezolizumab).

Redacted CSR Synopsis English

Plain Language Summary English

Redacted Protocol

Redacted SAP

The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab. 
This study also evaluated pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores were also assessed.

A Study of ASP2215 (Gilteritinib) Combined with Atezolizumab in Patients with Relapsed or Treatment Refractory FMS-like tyrosine kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)

This study was planned to have 2 phases:
Phase 1:
The phase 1 portion of this study was to establish the recommended phase 2 dose (RP2D) of gilteritinib given in combination with atezolizumab. 
Phase 2:
The phase 2 portion of the study was to treat participants with gilteritinib and atezolizumab at the RP2D and was to be enrolled in two stages. The first stage was to evaluate the remission rate and if a minimum rate was to be achieved, a second stage of enrollment was to be continued.

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Northwestern University

The Ohio State University Comprehensive Cancer Center (OSUCCC)

Vanderbilt Ingram Cancer Center

Medical University of South Carolina (MUSC) - Hollings Cancer Center (HCC)

Roswell Park Cancer Institute (RPCI)

Weill Cornell Medical College

Medical College of Wisconsin

University of Kentucky

University of Chicago

University of Texas MD Anderson

Columbia University Medical Center

Simmons Comprehensive Cancer Center

Ronald Reagan UCLA Medical Center

Phase 1/2 Study of ASP2215 (Gilteritinib) Combined with Atezolizumab in Patients with Relapsed or Treatment Refractory FLT3 Mutated Acute Myeloid Leukemia (AML)

Number of participants with CRc.
CRc is defined as a complete remission (CR), complete remission without platelet recovery (CRp) or complete remission with incomplete hematologic recovery (CRi).
CRc rate is defined as the rate of all complete and incomplete remission (i.e., CR + CRp + CRi).

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

The safety analysis set consisted of all participants who took at least 1 dose of study drug (gilteritinib or atezolizumab).

DLTs were defined as:
•Confirmed Hy’s Law case
•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 
                 o Grade 3 fever with neutropenia, with or without infection
                 o Grade 3 infection
                 o Grade 3 infusion-related toxicity, if successfully managed and resolved within 72 hours.

Number of Participants With Dose Limiting Toxicities (DLT)

CRc was defined as rate of all complete and incomplete remissions i.e. CR + CR with incomplete platelet recovery (CRp) + CR with incomplete hematological recover (CRi). 
Participants were classified as:
CR if they achieved morphologic leukemia-free state & their bone marrow was regenerating normal hematopoietic cells. If they had absolute neutrophil count (ANC) > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential < 5% blasts, & were red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia.
CRp if they achieved CR with incomplete platelet recovery (< 100 × 10^9/L).
CRi if they achieved CR with incomplete hematological recovery with residual neutropenia < 1 × 10^9/L, with or without complete platelet recovery. RBC and platelet transfusion independence was not required.
Percentage of participants with CRc was reported.

The full analysis set (FAS) consisted of all participants who were enrolled in the study and took at least 1 dose of study drug (gilteritinib or atezolizumab).

Composite Complete Remission (CRc) Rate

Pre-dose C1D1

Pre-dose C1D8

Pre-dose C1D15

Pre-dose C2D1

Pre-dose C2D15

Pre-dose C3D1

Pre-dose C3D15

Pre-dose C4D1

Pre-dose C4D15

Pre-dose C5D1

Pre-dose C5D15

Pre-dose C6D1

Pre-dose C6D15

Plasma Ctrough concentrations of gilteritinib was reported. One cycle = 28 days.
C= cycle, D=day

The pharmacokinetic analysis set (PKAS) consisted of the administered population for which sufficient plasma concentration data was available to facilitate derivation of at least 1 PK parameter and for whom at least 1 plasma concentration datum was available and both the date and time of dosing on the day of PK sampling and the date and time of sampling were known. Participants with available data at specified time point were included.

Plasma Ctrough Concentration of Gilteritinib

Participants were classified as CR if they achieved a morphologic leukemia-free state and their bone marrow was regenerating normal hematopoietic cells. In addition, these participants had ANC > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential with < 5% blasts, and were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. CR rate  was defined as the number of participants with CR divided by the number of participants in the analysis population. Percentage of participants with CR was reported.

Complete Remission (CR) rate

Participants were classified as CRh if they achieved CR with ANC level of > 0.5 × 10^9/L and platelet count of > 50 × 10^9/L. CRh rate  was defined as the number of participants with CRh divided by the number of participants in the analysis population.
Participants were classified as CR if they achieved a morphologic leukemia-free state and their bone marrow was regenerating normal hematopoietic cells. In addition, these participants had ANC > 1 × 10^9/L, platelet count ≥ 100 × 10^9/L, normal marrow differential with < 5% blasts, and were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion prior to disease assessment). There was also no evidence of extramedullary leukemia. Percentage of participants with CRh was reported.

Complete Remission With Partial Hematologic Recovery (CRh) Rate

Best response was defined as the best-measured response (CR, CRp, CRi or PR) post-treatment. Best response rate was defined as the number of participants with CR or CRp or CRi or PR divided by the number of participants in the analysis population (i.e., CR+ CRp + CRi + PR). Participants with unknown or missing response, or who provide no information on response at the end of study will be treated as non-responders and will be included in the denominator when calculating rates. CR, CRp and CRi were described in outcome measure 2#. Participants were classified as PR if their bone marrow was regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate/biopsy, with the total marrow blasts between 5% and 25%. Percentage of participants with best response was reported.

Best Response Rate

DoR: duration of CRc, CR, CRi, CRp & response (CRc + PR). Duration of CRc/CR/CRi/CRp: time from  date of first CRc/CR/CRi/CRp until date of documented relapse for participants who achieved CRc/CR/CRi/CRp. Duration of response: time from date of either first CRc or PR until date of documented relapse of any type for participants who achieved CRc or PR. CRc, CR, CRi, CRp were described in outcome measure #2 & PR was described in outcome measure #6. Relapse after CR, CRp or CRi: reappearance of leukemic blasts in peripheral blood  or ≥ 5% blasts in bone marrow aspirate/biopsy not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Relapse after PR: reappearance of significant numbers of peripheral blasts & an increase in the percentage of blasts in the bone marrow aspirate/biopsy to > 25% not  attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Analysis was  performed using Kaplan-Meier estimates.

Duration of Remission (DoR)

EFS was defined as time from date of first dose until date of documented relapse from CR, CRp or CRi, treatment failure or death from any cause, whichever occurred first. CRc, CR, CRi, CRp were described in Outcome measure #2. For a participant with none of these events, EFS was censored at date of last disease assessment. Relapse after CR, CRp or CRi was defined as reappearance of leukemic blasts in peripheral blood  or ≥ 5% blasts in bone marrow aspirate/biopsy not attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Relapse after PR was defined with reappearance of significant numbers of peripheral blasts & an increase in the percentage of blasts in the bone marrow aspirate/biopsy to > 25% not  attributable to any other cause or reappearance or new appearance of extramedullary leukemia. Treatment failure was defined as lack of CR, CRp or CRi, & was determined at the end of treatment (EoT). Analysis was performed using Kaplan-Meier estimates.

Event Free Survival (EFS)

OS was defined as the time from the date of first dose until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, overall survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier estimates.

Overall Survival (OS)

TEAE

Drug-Related Adverse Events

TEAE leading to Deaths

Drug-related TEAE Leading to Deaths

Serious Adverse Events

Drug-Related Serious Adverse Events

Adverse Events Leading to Withdrawal of Treatment

Drug-Related Adverse Events Leading to Withdrawal of Treatment

Grade 3 or Higher TEAE

Treatment Emergent Deaths

An AE  was any untoward medical occurrence in a participant administered study drug, & which did  not necessarily have to have a causal relationship with this treatment. Abnormalities was defined as AE only if met 1 of the criteria:Induced clinical signs/symptoms, required active intervention, required interruption or discontinuation of ST, abnormality or investigational value was clinically significant. Serious AE:resulted in death, was life threatening, persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, required hospitalization or prolongation of hospitalization, other medically important events. Any AE recorded on treatment including within 30 days from last study treatment was classified as treatment-emergent AE (TEAE). Grades(Gr) based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) (Gr 1=mild, Gr 2=moderate, Gr 3 =severe, Gr 4 =life threatening, Gr 5 =death).

Number of Participants with Treatment-Emergent Adverse Events

Baseline: Grade 0

Baseline: Grade 1

Baseline: Grade 2

Baseline: Grade 3

Baseline: Grade 4

Baseline: Grade 5

EoT: Grade 0

EoT: Grade 1

EoT: Grade 2

EoT: Grade 3

EoT: Grade 4

EoT: Grade 5

ECOG performance status was measured on an 6 point scale.
0-Fully active, able to carry on all pre-disease performance without restriction.
1-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
2-Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
3-Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
4-Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
5-Dead.

Safety population with available data at specified timepoint

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Score

Overall Study

Participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated acute myeloid leukemia (AML) were enrolled in this study.

Clinical trial Disclosure

Ctrough will be derived from pharmacokinetic (PK) plasma samples collected.

Number of participants with complete remission (CR)

Best response is defined as the best-measured response (CR, CRp, CRi or PR) post-treatment.

Duration of remission is defined as time from date of first CRc, CR, CRi, CRp, and response (CRc + PR) until the date of documented relapse.
Duration of remission includes duration of CRc, CR, CRi, CRp and response (CRc + PR).

EFS is defined as the time from the date of enrollment until the date of documented relapse from CR, CRp or CRi, treatment failure or death from any cause, whichever occurs first.

OS is defined as the time from the date of enrollment until the date of death from any cause. For a subject who is not known to have died by the end-of-study follow-up, OS is censored at the date of last contact.

Number of participants with complete remission (CR) with partial hematologic recovery (CRh)

An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.

Number of participants with potentially clinically significant laboratory values

Number of participants with potentially clinically significant vital sign values.

12-lead ECGs will be recorded in triplicate (3 separate ECGs, 10 minutes resting prior to first ECG and at least 5 minutes apart per time point) and transmitted electronically for central reading. The mean of the triplicate ECG from central read will be used for all final treatment decisions and adverse event reporting.

ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2= Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead. 0=Best status; 5=Worst status.