JPRN-jRCT2031210610进行中（未招募）1 期
A Phase I study of cabozantinib monotherapy in pediatric patients with recurrent and/or refractory solid tumors - CAMEL study
Arakawa Ayumu0 个研究点目标入组 18 人开始时间: 2022年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 3age old 至 <= 19age old（—）
- 性别
- All
入选标准
- •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 <=15 years) within 14 days prior to the enrollment.
- •7) Patients must meet one of the following criteria,
- •(1) Patients with at least one evaluable disease on contrast-enhanced computed tomography (CT) within 28 days prior to the enrollment. CT and magnetic resonance imaging (MRI) without a contrast medium are also acceptable for patients with the extracranial diseases, who cannot use a contrast medium. However, in cases of brain tumors, a craniocerebral contrast-enhanced MRI is required, and the patient is ineligible if the contrast-enhanced MRI cannot be performed.
- •(2) Tumor infiltration is confirmed by the bone marrow aspiration/biopsy.
- •8) No history of prior administration of cabozantinib, crizotinib, or tivantinib.
- •9) Patients with the primary brain tumors have not received any new or increased doses of corticosteroids either intravenously or orally, between seven days prior to and on the day of the brain contrast MRI performed within the 28 days prior to the enrollment. If a new or increased dose of corticosteroid is administered between the time of a brain contrast MRI, and start of the treatment according to the protocol. The baselines brain contrast MRI must be performed again before starting the treatment, according to the protocol.
- •10) Patients must not have been received any antineoplastic drugs or the other investigational drugs within 28 days prior to the enrollment.
- •11) Patients who have not undergone a surgery with general anesthesia within 28 days prior to the enrollment.
- •12) Patients who have not received the radiation therapy within 14 days prior to the enrollment.
- •13) Laboratory tests performed within seven days prior to the enrollment must meet all the following criteria. However, the patient must not have received a granulocyte colony-stimulating factor (G-CSF) or a blood transfusion within seven days prior to the date of the blood collection. No administration of a sustained G-CSF (PEG) within 14 days prior to the blood collection. The criteria are as follows,
- •(1) Neutrophil count >=1000/mm3,
- •(2) Platelet count >=7.5x10^4/mm3,
- •(3) Hemoglobin >=9.0 g/dL,
- •(4) Albumin >= 2.8 g/dL,
- •(5) Aspartate aminotransferase <= 3 times the upper limit of clinical laboratory standards,
- •(6) Alanine transaminase <= 3 times the upper limit of clinical laboratory standards,
- •(7) Total bilirubin <= 1.5 times the upper limit of clinical laboratory standards,
- •(8) Serum creatinine <= 1.5 times the upper limit of clinical laboratory standards,
- •(9) Amylase and lipase <= 1.5 times the upper limit of clinical laboratory standards,
- •(10) Urine protein <= 1+ by a qualitative test or UP/CR <0.5g/gCre in a single voided urine sample ,
- •(11) PT-INR <= 1.5.
- •14) Transcutaneous oxygen saturation (SpO2) of >=94 % under the room air within 14 days prior to the enrollme
排除标准
- •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 <0.35 m2 at the time of the enrollment.
- •10) Positive for either HIV antibody, HTLV-1 antibody, HBs antigen, or HCV antibody. However, patients with a positive HCV antibody, but no detectable HCV-RNA are not excluded.
- •11) Negative for the HBs antigen, positive for HBs antibody or HBc antibody, and positive for HBV-DNA quantification.
- •12) Women who are pregnant, lactating, or may be pregnant.
- •13) Patients with a psychosis or psychiatric symptoms that interfere with the daily life and are judged to be difficult to participate in the study.
- •14) History of any of the followings (within 6 months prior to enrollment) or complications,
- •(1) Diabetes mellitus judged to be poorly controlled,
- •(2) Chronic congestive heart failure (New York Heart Association cardiac function classification class III or higher),
- •(3) History of unstable angina, angioplasty, stent grafting, or myocardial infarction,
- •(4) Symptomatic or arrhythmia requiring a treatment or asymptomatic sustained ventricular tachycardia (but not asymptomatic controllable atrial fibrillation),
- •(5) QT prolongation syndrome requiring a treatment.
- •15) QT corrected for HR using Fridericia's method (QTcF) interval >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.
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