EUCTR2016-004390-41-DE进行中（未招募）1 期
A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors - ARROW
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 647
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 = 18 years of age.
- •2. Diagnosis during dose escalation (Phase 1) – Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
- •All patients treated at doses > 120 mg per day must have MTC, or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.
- •Phase 1 enrichment patients must have MTC or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.
- •3. Diagnosis during dose expansion (Phase 2) – All patients (with the exception of patients with MTC enrolled in Groups 3, 4 and 9) must have an oncogenic RET fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local testing of tumor or circulating tumor nucleic acid in blood; as detailed below.
- •Group 1 – patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion previously treated with a platinum-based chemotherapy.
- •Group 2 – patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion not previously treated with a platinum-based chemotherapy, including those who have not had any systemic therapy. Prior platinum chemotherapy in the neoadjuvant and adjuvant setting is permitted if the last dose of platinum was 4 months or more before the first dose of study drug.
- •Group 3 – patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit and was previously treated with cabozantinib and/or vandetanib.
- •Group 4 – patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit and was not previously treated with cabozantinib or vandetanib.
- •Group 5 – patients must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion, have previously received SOC appropriate for their tumor type (unless there is no accepted standard therapy for the tumor type or the Investigator has determined that treatment with standard therapy is not appropriate), and must not eligible for any of the other groups.
- •Group 6 – patients must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion or mutation, previously treated with a selective TKI that inhibits RET, such as selpercatinib.
- •Group 7: patients must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET mutation previously treated with SOC appropriate for the tumor type and not eligible for any of the other groups.
- •Group 8: patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion that was previously treated with a platinum-based chemotherapy (China only).
- •Group 9: patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit and was not previously treated with systemic therapy (except prior cytotoxic chemotherapy is allowed) for advanced or metastatic disease (China only).
- •4. Patients must have non-resectable disease. Prior to Protocol Amendment 9, patients must have progressed following standard therapy or have not adequately responded to standard therapy, or the patient must be intolerant to, or the Investigator has determine
排除标准
- •1. Patient's cancer has a known primary driver alteration other than RET. Investigators should discuss enrollment with Sponsor regarding comutations
- •2. Patient has any of the following within 14 d prior to the first dose of IMP:
- •a. Platelet count < 75 × 109/L
- •b. Absolute neutrophil count < 1.0 × 109/L
- •c. Hemoglobin < 9.0 g/dL red blood cell transfusion and erythropoietin may be used to reach at least 9.0 g/dL, but must have been administered at least 2 weeks prior to 1st IMP dose
- •d. AST or ALT > 3 × ULN if no hepatic metastases are present; > 5 × ULN if hepatic metastases are present
- •e. Total bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 × ULN in presence of Gilbert's disease
- •f. Estimated (Cockroft-Gault formula) or measured creatinine clearance < 40 mL/min
- •g. Total serum phosphorous > 5.5 mg/dL
- •3. Patient has a QTcF > 470 msec. Patient has a history of prolonged QT syndrome or Torsades de pointes. Patient has a familial history of prolonged QT syndrome
- •4. Patient has clinically significant, uncontrolled, cardiovascular disease including congestive heart failure Grade III or IV according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months, uncontrolled hypertension, or clinically significant, uncontrolled arrhythmias, including bradyarrhythmias that may cause QT prolongation
- •5. Patient has CNS metastases or a primary CNS tumor associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a patient requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks preceding C1D1
- •6. Presence of clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis
- •7. Patient received the following anti-cancer therapy:
- •a. Any systemic anticancer therapy (except for immunotherapy or other antibody therapies) and all forms of radiotherapy within 14 d or 5 halflives prior to first IMP dose. IMP may be started within these washout periods if considered by the Investigator to be safe and within the best interest of the patient prior Sponsor approval
- •b. Any immunotherapy or other antibody therapy within 28 d prior to the 1st dose of IMP (immune related toxicities must have resolved to < Grade 2 prior to starting IMP)
- •8. Dose expansion patients in Groups 1-5 and 7 (Phase 2): patient has previously received treatment with a selective RET inhibitor as selpercatinib
- •9. Patient received neutrophil growth factor support within 14 d of 1st IMP dose
- •10. Patient requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before start of IMP administration. IMP may be started within 14 d or 5 half-lives of prior therapy if considered by the Investigator to be safe and within the best interest of the patient, with prior Sponsor approval
- •11. Patient has had a major surgical procedure within 14 d of the first IMP dose
- •12. Patient has a history of another primary malignancy that has been diagnosed or required therapy (except maintenance anti-hormonal therapy) within the past year. The following prior malignancies are not Not exclusionary are: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, curatively treated localized thyroid cancer, and completely resected carcinoma in situ of any site
- •13. Patient is unwilling or unable to c
研究者
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