NCT02561455

Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

Completed Phase 1, PHASE2 Results posted Last updated 19 November 2024

What this trial tests

Phase 1, PHASE2 trial testing Gilteritinib in Advanced Solid Tumors in 9 participants. Completed in 28 July 2020.

Timeline

3 May 2016

Primary endpoint
28 July 2020

28 July 2020

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	3 May 2016
Primary completion	28 July 2020
Estimated completion	28 July 2020
Sites	7 locations across United States

Drugs / interventions tested

• Gilteritinib (GILTERITINIB) — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · 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)

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 op

Group	Value	95% CI
Gilteritinib 40 mg	2
Gilteritinib 80 mg	3
Gilteritinib 120 mg	3
Gilteritinib 200 mg	1

Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) Primary · EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days)

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-car

Grade 0

Group	Value	95% CI
Gilteritinib 40 mg	2
Gilteritinib 80 mg	0
Gilteritinib 120 mg	0
Gilteritinib 200 mg	0

Grade 1

Group	Value	95% CI
Gilteritinib 40 mg	0
Gilteritinib 80 mg	3
Gilteritinib 120 mg	0
Gilteritinib 200 mg	1

Grade 2

Group	Value	95% CI
Gilteritinib 40 mg	0
Gilteritinib 80 mg	0
Gilteritinib 120 mg	1
Gilteritinib 200 mg	0

Grade 3

Group	Value	95% CI
Gilteritinib 40 mg	0
Gilteritinib 80 mg	0
Gilteritinib 120 mg	0
Gilteritinib 200 mg	0

Grade 4

Group	Value	95% CI
Gilteritinib 40 mg	0
Gilteritinib 80 mg	0
Gilteritinib 120 mg	0
Gilteritinib 200 mg	0

Grade 5

Group	Value	95% CI
Gilteritinib 40 mg	0
Gilteritinib 80 mg	0
Gilteritinib 120 mg	0
Gilteritinib 200 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 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). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gilteritinib 40 mg

Serious: 2/2 (100%)

Deaths: 0/2

Gilteritinib 80 mg

Serious: 1/3 (33%)

Deaths: 0/3

Gilteritinib 120 mg

Serious: 2/3 (67%)

Deaths: 0/3

Gilteritinib 200 mg

Serious: 0/1 (0%)

Deaths: 0/1

Serious adverse events (13 terms)

Reaction	System	Gilteritinib 40 mg	Gilteritinib 80 mg	Gilteritinib 120 mg	Gilteritinib 200 mg
Obstructive pancreatitis	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Respiratory syncytial virus infection	Infections and infestations	—	—	—	—
Staphylococcal bacteraemia	Infections and infestations	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Myositis	Musculoskeletal and connective tissue disorders	—	—	—	—
Osteonecrosis	Musculoskeletal and connective tissue disorders	—	—	—	—
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—

Other adverse events (101 terms — click to expand)

Reaction	System	Gilteritinib 40 mg	Gilteritinib 80 mg	Gilteritinib 120 mg	Gilteritinib 200 mg
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—
Accommodation disorder	Eye disorders	—	—	—	—
Dry eye	Eye disorders	—	—	—	—
Eye pain	Eye disorders	—	—	—	—
Trichiasis	Eye disorders	—	—	—	—
Vitreous detachment	Eye disorders	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Anorectal discomfort	Gastrointestinal disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Oral mucosal hypertrophy	Gastrointestinal disorders	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Chronic graft versus host disease in eye	Immune system disorders	—	—	—	—
Chronic graft versus host disease oral	Immune system disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Klebsiella bacteraemia	Infections and infestations	—	—	—	—
Lip infection	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Peritonitis	Infections and infestations	—	—	—	—
Rhinovirus infection	Infections and infestations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—

Most-reported serious reactions: Obstructive pancreatitis, Pyrexia, Appendicitis, Respiratory syncytial virus infection, Staphylococcal bacteraemia, Blood creatine phosphokinase increased, Musculoskeletal pain, Myositis.

Data from ClinicalTrials.gov NCT02561455 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. AXL receptor tyrosine kinase as a promising anti-cancer approach: functions, molecular mechanisms and clinical applications.
   Zhu C, Wei Y, Wei X. · · 2019 · cited 398× · PMID 31684958 · DOI 10.1186/s12943-019-1090-3
2. Targeting MERTK and AXL in <i>EGFR</i> Mutant Non-Small Cell Lung Cancer.
   Yan D, Earp HS, DeRyckere D, Graham DK. · · 2021 · cited 27× · PMID 34830794 · DOI 10.3390/cancers13225639