Refractory pediatric solid tumor Malignant solid tumors
Conditions
Interventions
The initial dose of Cabozantinib is 40mg/m2. Administer orally once daily at intervals of 12 hours or more on empty stomach according to the prescribed dose and the day of the week. One cycle is 28 d
C558660
A multikinase inhibitor
Sponsors
Arakawa Ayumu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with a histologically confirmed malignant solid tumor. Hematological malignancies (such as leukemia, malignant lymphoma, and multiple myeloma) are not eligible. 2) Patients with any of the following conditions, (1)A recurrent or metastatic disease or no indication for curative surgery, (2)No standard treatment or refractoriness or intolerance to the standard therapy. 3) No evidence of the pericardial effusion, pleural effusion, or ascites requiring a treatment. 4) Age at enrollment, Cohort 1: 3-15 years; Cohort 2: 3-19 years. 5) Patients who could swallow a 5.6-mm-diameter tablet. 6) Performance status is >=50 (assessed by the KPS in patients aged >=16 years and LPS in patients aged =1000/mm3, (2) Platelet count >=7.5x10^4/mm3, (3) Hemoglobin >=9.0 g/dL, (4) Albumin >= 2.8 g/dL, (5) Aspartate aminotransferase =94 % under the room air within 14 days prior to the enrollme
Exclusion criteria
Exclusion criteria: 1)Patients with active multiple cancers. However, the following are not excluded. (1) Completely resected basal cell carcinoma, stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma, superficial bladder cancer, (2) Gastrointestinal cancer that has been curatively resected by the endoscopic resection, (3) Other cancers that have not recurred for >5 years. 2) Progressive symptomatic brain tumors and brain metastases, carcinomatous meningitis, spinal metastases requiring the radiation or surgical procedures. 3) Infectious diseases requiring a systemic treatment. 4) Patients with the active gastrointestinal ulcers. 5) Patients with an active or previous history of pneumonitis or pulmonary fibrosis diagnosed by the imaging or clinical findings. 6) Concomitant or history of a severe hypersensitivity reaction to the study drug. 7) History of an allogeneic hematopoietic stem cell transplantation. 8) Has undergone an autologous HSCT within 12 weeks prior to the enrollment. 9) Body surface area is 470 ms on 12-lead ECG performed within 14 days prior to the enrollment. 16) Patients who are judged by the investigator or sub-investigator to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the incidence of DLT-equivalent toxicities of cabozantinib monotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Safety endpoints: incidence rate of adverse events, Grade-4 non-hematologic toxicity, early death, incidence rate of treatment-related death and DLT-equivalent adverse events in Cohort 2. 2) Pharmacokinetic parameters: Cmax, Tmax, AUC0-24, AUC0-infinity, population pharmacokinetic parameters, 3) Efficacy endpoints: response rate, 16-week disease control rate, progression-free survival, overall survival, response rate by the cancer type, 16-week disease control rate by cancer type. | — |
Contacts
Public ContactAyumu Arakawa
National Cancer Center Hospital
Outcome results
None listed