EUCTR2013-004482-14-DE进行中（未招募）1 期
A phase I/II, multicenter, open-label study of EGFRmut–TKI EGF816,administered orally in adult patients with EGFRmut solid malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •For all patients (unless otherwise specified):
- •1. Written informed consent obtained prior to any screening procedures
- •2. Patient (male or female) = 18 years of age
- •3. Patients must have histologically or cytologically confirmed locally advanced (stage IIIB not amendable to definitive multi-modality therapy including surgery) or metastatic (stage IV) EGFR mutant NSCLC
- •4. Patients with controlled brain metastases may participate in the trial.
- •They must complete any planned radiation therapy and/or surgery > 2 weeks prior to the first dose of study treatment and remain asymptomatic. Patients on steroids must have been on a stable low dose for 2 weeks prior to initiating study treatment.
- •5. ECOG performance status: Phase I part: 0, 1, or 2; Phase II part: 0 or 1
- •6. Presence of at least one measurable lesion according to RECIST 1.1 per Investigator assessment. A previously irradiated site lesion may be counted as a target lesion only if there is clear sign of progression since the irradiation (see Section 14.1 Appendix 1)
- •7. Patients must be screened for HBV. Patients who are either HBsAq positivie or HBVDNA positive must be willing to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816.
- •8. Patients must be screened for HCV. Patients must have negative hepatitis C antibody (HCV-Ab) or positive HCV-Ab but undetectable level of HCV-RNA. Note patients with detectable HCV-RNA are not eligible to enroll into the study.
- •9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •10. Requirement of EGFR mutation status and prior lines of treatment for Phase I patients- (Please see section 5.2 of the protocol for more details)
- •11. Requirements of EGFR mutation status and prior lines of treatment for Phase II patients:
- •Locally advanced or metastatic NSCLC with EGFR activating mutation
- •(e.g. L858R and/or ex19del); Who have not received any systemic antineoplastic therapy, including EGFR TKI treatment, for advanced NSCLC; Note: patients who have received no more than 1 cycle of chemotherapy in the advanced setting are allowed.
- •Other protocol-defined inclusion criteria may apply?
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •For all patients (unless otherwise specified):
- •1. Patients with a history or presence of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention)
- •2. Patients with tumors harboring an EGFR exon 20 insertion or deletion (except for Group 4 patients in the Phase II par)
- •3. Presence or History of another malignancy
- •Exception: Patients who have been disease-free for 3 years, or patients with a history of adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma, non-melanomatous cancer of skin, history of stage IA melanoma that has been cured, are eligible.
- •4. Undergone a bone marrow or solid organ transplant
- •5. Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
- •6. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local injections
- •7. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
- •8. Patients with out of range laboratory values defined as:
- •Absolute Neutrophil Count (ANC) < 1.5 x 10^9/L (1.5 x 103/µL)
- •Hemoglobin (Hgb) < 9 g/dL
- •Platelets < 75 x 10^9/L
- •Total bilirubin >1.5 x ULN. For patients with Gilbert's syndrome total bilirubin >3.0 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN for patients without hepatic metastasis. AST and/or ALT >5 x ULN for patients with hepatic metastasis
- •Alkaline phosphatase (ALP) > 5 xULN
- •Fasting plasma glucose > 175 mg/dL (> 9.8 mmol/L)
- •Measured or calculated creatinine clearance < 45 mL/min (0.75 mL/sec)
- •9. Patients with electrolytes outside the laboratory normal limits that
- •cannot be corrected with supplements during screening:
- •Potassium
- •Magnesium
- •Phosphorus
- •Total calcium (corrected for serum albumin)
- •10. Patients receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 and cannot be discontinued 1 week prior to the start of EGF816 treatment and for the duration of the study.
- •Other protocol-defined exclusion criteria may apply
研究者
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