EUCTR2017-000439-14-NL进行中（未招募）1 期
A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must be < 25 years of age.
- •o Enrollment of patients = 18 years of age may be halted at any time during the study to ensure adequate enrollment of pediatric patients (< 18 years).
- •Patients must have relapsed or refractory cancer.
- •o Patients with high-risk neuroblastoma that is refractory after completion of at least 4 cycles of induction therapy (no response or stable disease as best response) are eligible to enroll in Part 2 (cohort expansion).
- •Patients must have adequate hepatic function.
- •Patient must have normal creatinine for age or have a calculated creatinine clearance = 60 mL/min/1.73 m2.
- •Patients = 16 years of age must have performance status of Lansky = 50 and patients > 16 years of age must have performance status of Karnofsky > 50%.
- •Patients with solid tumors must have adequate bone marrow function as defined by ANC = 1000/µl and platelets > 75,000/µl (with transfusion independence defined as not receiving platelet transfusion within 7 days prior to enrollment).
- •For the fifth cohort during Part 2, patients with solid tumors must have evidence of BCL-2 expression.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 115
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with primary brain tumors or disease metastatic to the brain.
- •For patients with leukemia, has overt CNS disease (CNS 3 status) as defined by CSF WBC > 5/hpf with blasts on cytospin or any cranial nerve palsy regardless of cell count.
- •Patients who have received any of the following within the listed time frame, prior to the first dose of study drug
- •o Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days
- •o CAR-T infusion or other cellular therapy within 30 days
- •o Anticancer therapy including blinatumomab or chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter
- •o Steroid therapy for anti-neoplastic intent within 5 days
- •o Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
- •Patients who are less than 100 days post-transplant, or = 100 days post-transplant with active GVHD, or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug.
- •Patients who are less than 6 weeks post-131 I-mIBG therapy.
- •Patients who have received the following within 7 days prior to the first dose of study drug:
- •o Strong and moderate CYP3A inhibitors (Part 1);
- •o Strong and moderate CYP3A inducers (Part 1 and Part 2).
- •Patients who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
- •Patients who have active, uncontrolled infections.
- •Patients with malabsorption syndrome or any other condition that precludes enteral administration.
研究者
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