EUCTR2011-001988-52-NL进行中（未招募）1 期
Cross-tumoral Phase 2 clinical trial exploring Crizotinib (PF-02341066) in patients with advanced tumours induced by causal alterations of either ALK or MET. - CREATE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 582
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
- •Step 1 registration:
- •? Local diagnosis of locally advanced and/or metastatic malignant
- •tumor (ALCL, IMFT, PRCC, ASPS, CCSA, ARMS) deemed incurable by
- •conventional surgery, radiotherapy, systemic therapy or any other
- •? Mandatory availability for shipment of formalin-fixed, paraffin embedded, tumor-containing, non-returnable tissue blocks from primary tumor and/or metastatic site ( Slides not accepted). Information on previous histopathology reports and previous molecular analysis will be entered in an eCRF, to accompany the tissue samples.
- •? Written informed consent for central collection of tissue block and any other trial-specific procedures must be obtained from the patient
- •allowing for collection storage and analysis of tissue and screening
- •procedures prior to registration.
- •Step 2 histopathology central confirmation:
- •? Confirmation of receipt of tissue block and accompanying required
- •local information, and confirmation that tissue block contains tumor
- •tissue (quality assurance) by central biorepository through EORTC, as
- •well as central pathology confirmation, are required before starting the patient screening (step 3) according to chapter 6.4.
- •Step 3 enrollment:
- •? Measurable disease according to RECIST 1.1 with target lesion of at
- •least 20 mm (or 10 mm on spiral CT scans) and presence of at least one RECIST-measurable lesion outside of a previously radiated field or
- •potential palliative irradiation fields.
- •? Patients with brain metastases are eligible if treated and/or
- •neurologically stable with no ongoing requirement for corticosteroids
- •(off steroids for at least 2 weeks) and not taking contraindicated
- •medications . Absence of spinal cord compression unless treated with
- •the patient attaining good pain control and stable or recovered neurologic function.
- •? Minimum age 1 year, no upper age limit.
- •? Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Lansky Play scale >= 50 for children aged 1 to 12 yo.
- •? Adequate hematological function: ANC = 1 x 109/L, platelets = 30 x
- •109/L and hemoglobin = 8 g/dL.
- •? Adequate renal function:
- •A) For patients up to 21 years old:
- •The Schwartz formula should be used for Clearance Creatinine [mL/min/1.73 m2 = F x Height (cm) x 88.4/creatinine (blood) in µmol/L. ClCr of 80-140 mL/min/1.73 m2 is considered as normal range
- •- F = 0.55 for boys 1-15 yo
- •- F = 0.70 for boys 16-21 yo
- •- F = 0.55 for girls 1-21 yo
- •B) For patients 21 years or older: serum creatinine = 2 x ULN.
- •? Adequate liver function: Bilirubin = 1.5 x ULN unless due to Gilbert's syndrome (status of the disease documented by repeated laboratory values with slight increase in bilirubin without any other known causes). AST and ALT = 2.5 x ULN in the absence of liver metastases and = 5 x UNL if liver function abnormalities are due to the underlying malignancy.
- •? Clinically normal cardiac function based on the institutional lower limit of normal LVEF (assessed by MUGA or ECHO) and normal 12 lead ECG.
- •? Machine-read ECG with QTcF interval =470 msec.
- •? Women of child bearing potential with negative serum pregnancy test
- •? All patients of childbearing/reproductive potential using adequate
- •birth control
- •Disease specific inclusion criteria for patients with anaplastic large cell
- •lymphoma (ALCL)
- •? Patient may have received previous systemic treatment, surgery
- •and/or radiotherapy for localized, locally advanced or advanced disease.
- •? Patient must have received previous systemic ch
排除标准
- •? Malignant meningitis or leptomeningeal disease.
- •? Any previous systemic anticancer therapy in the last 4 weeks prior to
- •initiation of study medication.
- •? Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug before treatment with crizotinib (whatever is the longest period).
- •? Prior therapy directly targeting ALK and/or MET, Previous treatment
- •with crizotinib.
- •? Major surgery in past 4 weeks prior to initiation of study medication.
- •? Prior palliative radiotherapy 24 hrs prior to initiation of study
- •medication, and minor surgical procedures two weeks prior to the
- •initiation of study medication.
- •? Other previous and active malignancy for the last three years with the exception of non-melanoma skin cancer, localized cervical cancer,
- •localized and presumably cured prostate cancer or adequately treated
- •basal or squamous cell skin carcinoma.
- •? Laboratory abnormalities that would impart, in the judgment of the
- •investigator and/or sponsor, excess risk associated with study
- •participation or study drug administration.
- •? All related adverse events from previous therapies must have
- •recovered to = Grade 1 (except alopecia). No persistence of adverse
- •events from prior anti-cancer therapy deemed clinically relevant.
- •? Acute or chronic severe gastrointestinal conditions such as diarrhea or ulcer.
- •? Within the three months prior to starting study treatment, no
- •myocardial infarction, no severe/unstable angina, no coronary/peripheral artery bypass graft, congestive heart failure or cerebrovascular accident including transient ischemic attack.
- •? Ongoing cardiac dysrhythmias of NCI CTCAE Grade = 2.
- •? Uncontrolled atrial fibrillation of any grade.
- •? History of extensive disseminated/bilateral or known presence of
- •Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a
- •history of pneumonitis, hypersensitivity pneumonitis, interstitial
- •pneumonia, interstitial lung disease, obliterative bronchiolitis, and
- •pulmonary fibrosis, but not history of prior radiation pneumonitis.
- •? Concurrent use of drugs or foods that are known strong CYP3A4
- •inhibitors, including but not limited to atazanavir, clarithromycin,
- •indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir,
- •saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice (refer to section 5.6). The topical use of these medications (if appropriate), such as 2% ketoconazole cream, may be allowed.
- •? Concurrent use of drugs that are known potent CYP3A4 inducers, within 12 days prior to first dose of crizotinib including but not limited to carbamazepine, phenobarbital, phenytoin,
- •rifabutin, rifampin, and St. John's wort (refer to section 5.6).
- •? Use of drugs that are CYP3A4 substrates with narrow therapeutic
- •indices, including but not limited to pimozide, dihydroergotamine,
- •ergotamine, astemizole, cisapride, and terfenadine (refer to section 5.6).
- •? Other severe acute or chronic medical conditions including severe
- •gastrointestinal conditions such as diarrhea or ulcer) or psychiatric
- •conditions or end stage renal disease on hemodialysis or laboratory
- •abnormalities that would impact, in the judgment of the investigator
- •and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for study entry.
- •? Female subjects who are breast feeding
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