EUCTR2013-000144-26-FR进行中（未招募）1 期
A Phase 1/2, multicenter, open-label, dose-finding study to assess the safety, tolerability, andpreliminary efficacy of weekly nab-paclitaxel in pediatric patients with recurrent or refractorysolid tumors.
Abraxis BioScience, LLC, a wholly-owned subsidiary of Celgene Corporation0 个研究点目标入组 107 人开始时间: 2013年8月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
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
- •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 = 21 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 one of the following tumor types and has failed first or
- •second-line treatment or has evidence of refractory disease
- •i. Group 1: neuroblastoma
- •ii. Group 2: rhabdomyosarcoma
- •iii. Group 3: mixed solid tumors, including nonrhabdomyosarcoma soft tissue
- •sarcoma, melanoma, or other tumor types identified during the Phase 1 portion or in preclinical studies
- •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)
- •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 and for
- •3 months following the last dose of study medication
- •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, injectable, or implantable
- •hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) including at least one barrier method.
- •b. Have negative serum pregnancy test result at screening confirmed by negative
- •urine pregnancy dipstick within 72 hours prior to first dose of IP (if serum test
- •occurred > 72 hours from first dose); pregnancy test with sensitivity of at least 25
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly
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 received therapeutic dose chemotherapy or radiotherapy = 21 days prior to start of IP.
- •3. The patient has received maintenance dose chemotherapy (e.g., low dose
- •cyclophosphamide) = 7 days from the first dose of IP.
- •4. 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
- •5. 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.
- •6. The patient has had major surgery or significant trauma = 14 days prior to start of IP.
- •7. The patient has not recovered from the acute toxic effects of prior chemotherapy,
- •radiation, or major surgery/significant trauma.
- •8. The patient has had minor surgery = 7 days from the start of study treatment (excluding the placement of central/
- •peripheral lines, skin biopsy).
- •9. The patient has a known history of stroke, myocardial infarction, peripheral vascular disease, or recent (within 3 months) uncontrolled deep venous thrombosis.
- •10. The patient has a known history or current diagnosis of HIV infection, regardless of treatment status.
- •11. 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.
- •12. The patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
- •13. 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.
- •14. The patient has any condition that confounds the ability to interpret data from the study.
- •15. 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
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