NIPH Clinical Trials Search

JRCT ID: jRCTs041200030

Registered date:10/07/2020

A feasibility study of patient-proposed healthcare services with entrectinib in patients with ROS1-fusion-positive pediatric brain tumors

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPediatric brain tumor
Date of first enrollment03/08/2020
Target sample size1
Countries of recruitment
Study typeInterventional
Intervention(s)entrectinib at a dose of 600 mg/m2 orally once per day


Primary OutcomeOverall best response until four courses
Secondary OutcomeProgression-free survival time, the number of adverse events

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum<= 15age old
Include criteria1.Primary brain tumors with ROS1 gene fusions that are locally advanced; gene fusions are defined as those predicted to translate into a fusion protein with a functional ROS1 kinase domain, without a concomitant second oncodriver (e.g. known, activating mutations in EGFR, KRAS) as determined by a nucleic acid-based diagnostic testing method approved in Japan. 2.Patients who have no satisfactory treatment options for primary CNS tumors. 3.Performance status: PS (ECOG) 0-2 and minimum life expectancy of at least 4 weeks. 4.Age: Male or female from birth to age <=15 years. 5.Patients must have measurable or evaluable disease, as defined in RANO. Measurable disease is defined as bidimensionally contrast enhancing lesions with clearly defined margins by CT or MRI scan, with two perpendicular diameters of at least 10 mm, visible on two or more axial slices that are preferably, at most, 5 mm apart with 0-mm skip. 6.No prior treatment with approved or investigational ROS1 inhibitors. 7.Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment. 8.XRT/External Beam Irradiation: >=14 days after whole brain XRT;>=7 days after stereotactic radiation surgery. 9.Organ function; i. ANC >= 1,000/microL; ii. Hemoglobin >= 8.0 g/dL (without transfusion within 14 days of registration) iii. Platelet count >= 75,000/microL (without transfusion) iv. Bilirubin <= 1.5 mg/dl v. ALT <= 3 x upper limit of normal (ULN) vi. Serum creatinine <= ULN for age (5>=; 0.8mg/dl, 5-10; 1.2mg/dl and 10<=; 1.5mg/dl) vii. ECG with QTcF <= 480 msec 10. Written informed consent: A signed informed consent and/or assent for study participation will be obtained from patients, parents or caregivers. (Written informed consent should be obtained from patients more than 7 years old.).
Exclude criteria1.Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2. Active infection requiring systemic therapy. 3.Body temperature >= 38 degrees Celsius at registration. 4.Women during pregnancy, possible pregnancy or breast-feeding. 5.Continuous systemic use of immunosuppressant including steroid. 6.Uncontrolled diabetes mellitus or routine administration of insulin. 7.Congestive heart failure within 3 months or ejection fraction <= 50%. 8.Inadequately controlled hypertension. 9.Known congenital long QT syndrome. 10.Familial history of long QT syndrome. 11.Positive HBs antigen, positive HBs antibody or positive HBc antibody. 12.Positive HCV antibody. 13.Positive HIV antibody. 14.Pneumonitis, pulmonary fibrosis, or severe lung emphysema on chest CT. 15.Patients who were judged as inappropriate for entry in this study by the principal investigator or sub-investigators.

Related Information


Public contact
Name Hideki Muramatsu
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi Aichi Japan 466-8550
Telephone +81-52-744-2294
Affiliation Nagoya University Hospital
Scientific contact
Name Michihiro Kurimoto
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi Aichi Japan 466-8550
Telephone +81-52-744-2353
Affiliation Nagoya University Hospital