A Phase 1/2, multicenter, open-label, dose-finding study to assess the safety, tolerability, and preliminary efficacy of weekly nab-paclitaxel in pediatric patients with recurrent or refractory solid tumors.

Celgene Corporation0 个研究点目标入组 107 人开始时间: 2013年7月29日最近更新: 2019年2月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Celgene Corporation
入组人数: 107

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1. Patient is male or female, meeting the following age requirements at the time the
•informed consent document (and assent form, if applicable) is signed.
•a. Phase 1: patient is = 6 months to < 18 years of age
•b. Phase 2: patient is = 6 months to = 24 years of age
•2. Patient has a confirmed solid tumor diagnosis according to the following:
•a. Phase 1: patient has a recurrent or refractory solid tumor that has progressed or did not respond to standard therapy, or for which no standard anticancer therapy exists
•b. Phase 2: patient has radiologically documented measurable disease by RECIST 1.1 (for neuroblastoma, evaluable disease by MIBG/Curie score is also
•acceptable) in one of the following tumor types and has failed up to three lines of treatment
•i. Group 1: neuroblastoma (patients with bone marrow disease only are not permitted)
•ii. Group 2: rhabdomyosarcoma
•iii. Group 3: Ewing's sarcoma
•3. The patient has a Lansky/ Karnofsky performance status score of = 70%
•4. The patient has adequate serum chemistry levels, evidenced by the following laboratory values
•a. AST (SGOT), ALT (SGPT) = 2.5 × upper limit of normal range (ULN)
•b. Total bilirubin = 1.5 × ULN
•c. Creatinine = 1.5 × ULN
•5. The patient has adequate bone marrow function, evidenced by the following:
•a. Absolute neutrophil count = 1.0 × 10^9 cells/L
•b. Platelets = 80 × 10^9 cells/L (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample). In the Phase 2
•portion, for patients with known bone marrow involvement, platelets = 50 × 109 cells/L.
•c. Hemoglobin = 8 g/dL (transfusion is permitted to fulfill this criterion)
•6. The patient (when applicable) or patient’s parent(s) or legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/ procedures being conducted. Where locally applicable, the patient also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted.
•7. Male patients of childbearing potential must use a condom during sexual intercourse and shall not father a child during the study and for 6 months after the last dose of study medication.
•8. Female patients of childbearing potential [defined as all female patients = 12 years old or who have reached menarche, whichever occurs first] must have both of the following:
•a. Agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study medication or for a longer period if
•required by local regulations
•i. True abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
•ii. Acceptable contraceptive methods include: oral, injecta

排除标准

•1. The patient has a primary brain tumor(s) or brain metastasis (unless metastasis is treated and stable for > 28 days). In patients who are symptomatic, a brain scan is required to exclude metastasis.
•2. The patient has = Grade 2 peripheral neuropathy by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) at screening.
•3. The patient has received therapeutic dose chemotherapy or radiotherapy = 21 days prior to start of IP.
•4. The patient has received maintenance dose chemotherapy (e.g., low dose cyclophosphamide) = 7 days from the first dose of IP.
•5. The patient has received any investigational therapy = 28 days prior to start of IP.
•Investigational therapy is defined as any medicinal product that is not approved in the country of treatment for any indication, adult or pediatric
•6. The patient has received any biological therapy = 7 days prior to the start of IP, or monoclonal antibody = 3 half-lives or 28 days, whichever is shorter, prior to the first dose of IP.
•7. The patient has received allogenic hematopoietic stem cell transplantation (HSCT) = 3 months or autologous HSCT = 21 days prior to start of IP.
•8. The patient has had major surgery or significant trauma = 14 days prior to start of IP.
•9. The patient has not recovered from the acute toxic effects of prior chemotherapy, radiation, or major surgery/significant trauma.
•10. The patient has had minor surgery = 7 days from the start of study treatment (excluding the placement of central/
•peripheral lines, skin biopsy).
•11. The patient has a known history of stroke, myocardial infarction, peripheral vascular disease, or recent (within 3 months) uncontrolled deep venous thrombosis.
•12. The patient has a known history or current diagnosis of HIV infection, regardless of treatment status.
•13. The patient has an uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•14. The patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
•15. The patient has any condition, including the presence of laboratory abnormalities, that places him/her at unacceptable risk if he/she were to participate in the study.
•16. The patient has any condition that confounds the ability to interpret data from the study.
•17. The patient or parent(s)/guardian(s) is/are unable to comply with the study visit schedule and other protocol requirements, in the opinion of the investigator.

研究者

发起方

Celgene Corporation

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