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The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of the study discontinuation criteria in the present study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gilteritinib 40 mg | Experimental | Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
|
| Gilteritinib 80 mg | Experimental | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
|
| Gilteritinib 120 mg | Experimental | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
|
| Gilteritinib 200 mg | Experimental | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gilteritinib | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator. | From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days) |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) | ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease 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. Number of participants with ECOG performance status was reported. | EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days) |
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Inclusion Criteria:
Subject must currently be participating in an Astellas sponsored, single agent ASP2215 trial, receiving ASP2215 and have not met any discontinuation criteria of the parent study and can enroll into this rollover study without interruption of study drug, or with no more than 2 weeks interruption in study drug.
Subject must be deriving benefit from continued treatment without any persistent intolerable toxicity from continued treatment of ASP2215.
Female subject must either:
Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
Female subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 120 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period and, for 120 days after the final study drug administration.
Subject agrees not to participate in another interventional study while on treatment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Executive Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US10005 | Phoenix | Arizona | 85084 | United States | ||
| Site US10003 |
Not provided
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
Not provided
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Participants with Acute myeloid leukemia (AML) and advanced solid tumors who completed the protocol requirements of the previous ASP2215 trial (NCT02014558 and NCT02456883) were included in this study. 9 participants were screened.
Participants from previosuly conducted ASP2215 trial were recruited to receive gilteritinib at a dose specified at the time of their end of study visit in the previous ASP2215 study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gilteritinib 40 mg | Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2018 | Jul 21, 2021 |
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|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Site US10006 | New York | New York | 10032 | United States |
| Site US10007 | New York | New York | 10065 | United States |
| Site US10001 | Cleveland | Ohio | 44195 | United States |
| Site US10004 | Hershey | Pennsylvania | 17033 | United States |
| Site US10008 | Philadelphia | Pennsylvania | 19104 | United States |
| FG001 | Gilteritinib 80 mg | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| FG002 | Gilteritinib 120 mg | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| FG003 | Gilteritinib 200 mg | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis population was the safety analysis set (SAF), which consisted of all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gilteritinib 40 mg | Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| BG001 | Gilteritinib 80 mg | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| BG002 | Gilteritinib 120 mg | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| BG003 | Gilteritinib 200 mg | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. Grade 0 = fully active, able to carry on all pre disease performance without restriction; Grade 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. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator. | Participants in the SAF were analyzed. | Posted | Count of Participants | Participants | From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) | ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease 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. Number of participants with ECOG performance status was reported. | Participants in the SAF with available data were analyzed. | Posted | Count of Participants | Participants | EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days) |
|
From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gilteritinib 40 mg | Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | 0 | 2 | 2 | 2 | 2 | 2 |
| EG001 | Gilteritinib 80 mg | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Gilteritinib 120 mg | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Gilteritinib 200 mg | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Accommodation disorder | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Oral mucosal hypertrophy | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chronic graft versus host disease in eye | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Chronic graft versus host disease oral | Immune system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Lip infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
| |
| Conjunctival abrasion | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood insulin abnormal | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Lentigo | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
|
"Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Astellas Pharma Global Development, Inc | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2020 | Jul 21, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609080 | gilteritinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade 1 |
|
Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| OG002 | Gilteritinib 120 mg | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| OG003 | Gilteritinib 200 mg | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
|
|