EUCTR2013-003596-35-FR进行中（未招募）1 期
An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects with Cancer or Plexiform Neurofibromas and Trametinib in Combination with Dabrafenib in Children and Adolescents with Cancers Harboring V600 mutations.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
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. Written informed consent – a signed informed consent and/or assent (as age appropriate) for study participation including pharmacokinetics sampling will be obtained according to institutional guidelines.
- •2. Male or female between 2 years and < 18 years of age (inclusive) at the time of signing the informed consent form (Part C between 12 months and < 18 years of age, inclusive).
- •3. Must have a disease that is relapsed/refractory to all potentially curative standard treatment regimens or have a disease for which there are no standard treatment regimens that are potentially curative.
- •4. Prior therapy: The subject’s cancer (not NF-1 with PN) must have relapsed after or failed to respond to frontline curative therapy or there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities. All subjects (including NF-1 with PN) must have recovered to grade =1 from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment.
- •5. Performance score of =50% according to the Karnofsky/Lansky performance status scale.
- •6. Females of child-bearing potential must be willing to practice acceptable methods of birth control (see Section 10.1 of protocol). Additionally, females of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment, throughout treatment period and for 4 months after last dose of study drug.
- •7. Must have adequate organ function as defined by the following values:
- •- Renal function: 24 hr creatinine clearance (revised Schwartz formula), or radioisotope glomerular filtration rate (GFR) = 60 mL/min/1.73 m2; or a serum creatinine = ULN for age and gender as defined in the table on page 73 of the protocol.
- •- Liver function defined as:
- •a. Bilirubin (sum of conjugated + unconjugated) = 1.5 x ULN for age
- •b. ALT <2.5 x ULN; for the purposes of enrollment and toxicity monitoring the ULN for ALT will be 45 U/L.
- •- Cardiac function defined as:
- •a. Corrected QT (QTcB) interval <480 msec
- •b. LVEF =LLN by ECHO
- •8. Able to swallow and retain enterally (PO or nasogastric or gastric tube) administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as alabsorption syndrome or major resection of the stomach or bowels.
- •9. Adequate Blood Pressure Control defined as:
- •- Blood pressure = the 95th percentile for age, height, and gender (Appendix 7 in protocol) measured as described in Section 3.13.3.1.
- •10. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 94
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Lactating or pregnant female.
- •2. History of another malignancy including resected non-melanomatous skin cancer.
- •3. Subjects with NF-1 associated optic pathway tumors are excluded if they are actively receiving therapy for the optic pathway tumor or do not meet criteria for PN or malignant solid tumor (Subjects with NF-1 and isolated optic pathway tumors as only site of evaluable tumor are not eligible for enrollment).
- •4. Subjects with a history of NF-1 related cerebral vascular anomaly are excluded.
- •5. Subjects with NF-1 and active optic glioma are excluded.
- •6. Subjects with NF-1 and PN that cannot be evaluated by volumetric analysis.
- •7. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures.
- •8. Any prohibited medication(s), currently used or expected to be required, as described in Section 9.2.
- •9. Any medications for treatment of left ventricular systolic dysfunction
- •10. Part B and Part C only: Previous treatment with dabrafenib (cohort B4), trametinib or another MEK inhibitor (exception: prior treatment with sorafenib is permitted)
- •11. Administration of an investigational study treatment within 30 days preceding the first dose of study treatment(s) in this study.
- •12. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study treatment or excipients that contraindicate their participation.
- •13. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or liver metastases).
- •14. History of hepatic sinusoid obstructive syndrome (venoocculsive disease) within the prior 3 months.
- •15. History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •16. History of interstitial lung disease or pneumonitis.
- •18. History or current evidence RVO or RPED
- •19. For subjects with solid tumors that are not primary CNS tumors, subjects with symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression are excluded.
- •NOTE: Subjects previously treated for these conditions that have had stable CNS disease (verified with consecutive imaging studies) for >3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose or decreasing of corticosteroids for at least 7 days prior to enrolment are permitted.
- •20. A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection. Subjects with laboratory evidence of cleared HBV and HCV infection may be enrolled.
- •21. Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) [NCI, 2009] Grade 2 or higher from previous anti-cancer therapy, except alopecia.
- •22. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the Gla
研究者
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