NL-OMON50736已完成不适用
A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies - M13-833
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 4
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
- 2 至 99（—）
入选标准
- •1. 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).
- •2. 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).
- •o Patients with confirmed diagnosis of TCF3-HLF ALL are eligible to enroll in
- •the 5th cohort in Part 2 (cohort expansion) beginning on or after Day 15 of
- •induction or the end of induction and will be assessed independently of other
- •subject with ALL.
- •3. Patients must have adequate hepatic function.
- •4. Patient must have normal creatinine for age or have a calculated creatinine
- •clearance >= 60 mL/min/1.73 m2.
- •5. 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%.
- •6. In Part I, patients with solid tumors (with the exception of neuroblastoma)
- •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).
- •7. For the fifth cohort during Part 2, patients with solid tumors must have
- •evidence of BCL-2 expression.
排除标准
- •1. Patients with primary brain tumors or disease metastatic to the brain.
- •2. Patients who have CNS disease with cranial involvement that requires
- •3. Patients who have received any of the following within the listed time
- •frame, prior to the first dose of study drug
- •- Inotuzumab ozogamicin within 30 days
- •- Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days
- •- CAR-T infusion or other cellular therapy within 30 days
- •- Anticancer therapy including blinatumomab or chemotherapy, radiation therapy,
- •targeted small molecule agents, investigational agents within 14 days or 5
- •half-lives, whichever is shorter
- •- Exceptions: Ph+ ALL subjects on TKIs at Screening may enroll and remain
- •therapy to control disease.
- •- Steroid therapy for anti-neoplastic intent within 5 days
- •- Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
- •4. 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.
- •5. Patients who are less than 6 weeks post-131 I-mIBG therapy.
- •6. Patients who have received the following within 7 days prior to the first
- •dose of study drug:
- •- Strong and moderate CYP3A inhibitors (Part 1);
- •- Strong and moderate CYP3A inducers (Part 1 and Part 2).
- •7. Patients who have not recovered from clinically significant adverse
- •effect(s)/toxicity(s) of the previous therapy.
- •8. Patients who have active, uncontrolled infections.
- •9. Patients with malabsorption syndrome or any other condition that precludes
- •enteral administration.
研究者
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