pediatric, adolescent and young adult patient with malignant solid tumors Malignant solid tumors
Conditions
Interventions
Sponsors
Arakawa Ayumu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Having a diagnosis of malignant solid tumor (but not having any hematological tumor). 2)Patients corresponding to all the followings: (1)Having recurrent or metastatic tumor, or advanced tumor with no indication of curative surgery (2)Standard therapy is either not available, or ineffective or intolerant 3)Not having any of the followings: pericardial fluid, pleural effusion or ascites requiring treatment. 4)Aged between 3 and 19 (Dose Escalation Part) and 3 and 29 (Extended Part) at recruitment. 5)Patients who can be orally administered. 6)Performance Status is =>50 (assessed by KPS in =>16 years patients, and LPS in 1,000/mm3 (2)Platelet count => 7.5 x 104/mm3 (3)Hemoglobin => 10.0 g/dL (4)AST 94% of SpO2 under room air conditions within 14 days before registration. 15)Consent to contraception and limited breast-feeding. 16)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 5 years). 2)Not having any of the followings in patients in Dose Escalation Part: symptomatic brain tumor or brain metastasis, carcinomatous meningitis, or spinal metastasis requiring radiotherapy or surgical intervention 3)Infection requiring systemic therapy. 4)Active gastrointestinal ulceration. 5)Current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings (except for inactive scar or fibrosis associated with radiotherapy). 6)Current or previous severe hypersensitive reaction to medicines. 7)Having history of allogenic transplant. 8)Having history of auto transplant within 84 days before registration. 9)Body surface area 450 ms is observed more than twice. 16)Other conditions which the primary investigator or sub-investigator determine that the trial is inappropriate in consultation with the Clinical Trial Coordinating Office or the Trial Coordinating Committee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of dose-limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Safety (Incidence of adverse events, Grade 4 non-hematological incidence, early mortality, treatment-related mortality) 2)Pharmacokinetics ((C1D1)Cmax, Tmax, AUClast, AUCtau, AUCinf, Kel, T1/2, CL/F, Vz/F, (C1D15) Cmax, Ctrough, Cavg, Tmax, AUCtau, Kel, T1/2, CLss/F, Vz/F) 3)Efficacy (overall response rate, progression-free survival, overall response rate with each type of tumor, overall response rate with the tumor where EZH2 inhibitor was recommended by an examination for gene panel) | — |
Contacts
Public ContactNCCH1904 Clinical Trial Coordinating Office
National Cancer Center Hospital
Outcome results
None listed