EUCTR2017-000800-59-DK进行中（未招募）1 期
A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001) - LIBRETTO-001
oxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company0 个研究点目标入组 995 人开始时间: 2018年10月15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
- 995
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.Patients with a locally advanced or metastatic solid tumor who:
- •have progressed on or are intolerant to standard therapy, or
- •no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or
- •decline standard therapy.
- •2.Prior MKIs with anti-RET activity are allowed.
- •3.A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required
- •4.Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type.
- •5.At least 18 years of age.
- •For countries and sites where approved, patients as young as 12 years of age may be enrolled.
- •6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (age = 16 years) or Lansky Performance Score (LPS) = 40% (age < 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment.
- •7.Life expectancy of at least 3 months.
- •8.Archived tumor tissue sample available.
- •9.Adequate hematologic status, defined as:
- •Absolute neutrophil count (ANC) = 1.0.10^9/L not requiring growth factor support for at least 7 days prior to treatment, and
- •Platelet count = 75.10^9/L not requiring transfusion support for at least 7 days prior to treatment, and
- •Hb = 9 g/dL not requiring transfusion support or erythropoietin for at least 7 days prior to treatment.
- •10.Adequate hepatic function, defined as:
- •ALT and AST = 2.5 ULN or = 5 ULN with documented liver involvement (such as liver metastasis or a primary biliary tumor); and
- •Total bilirubin = 1.5 ULN or = 3 ULN with documented liver involvement (patients with Gilbert’s Disease may be enrolled with prior Sponsor approval).
- •11.Adequate renal function, with estimated glomerular filtration rate = 30 mL/minute (up to 6 patients with an estimated glomerular filtration rate (eGFR) = 15 and < 30 will be allowed to enroll with Sponsor approval).
- •12.Ability to swallow capsules and comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
- •13.Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 1 month following the last dose of study treatment;
- •As for phase 1 with the following modifications:
- •1.Cohorts 1 and 3: failed or intolerant to standard of care. Cohorts 2 and 4 without prior standard first line therapy.
- •2.Cohorts 1-4: enrollment will be restricted to patients with evidence of a RET gene alteration in tumor (i.e., not just blood) as defined in Table 3 3. However, a positive germline DNA test for a RET gene mutation as defined in Table 3 3 is acceptable in the absence of tumor tissue testing for patients with MTC.
- •3.Cohorts 1-4: at least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated (unless PD for the irradiated lesion[s] has been radiographically documented).
- •4.Cohort 4: radiographic PD within the previous 14 months.
- •5. Cohort 6: Patients who otherwise are eligible for Cohorts 1-5 who discontinued another RET inhibitor may be eligible with prior Sponsor approval.
- •Note: Examples of RET inhibitors may include TPX0046, pralsetinib (BLU-667), or BOS172739.
- •6.Cohort 5: Patients who otherwise are eligible for:
- •Cohorts 1-4 without measurable dise
排除标准
- •1.Phase 2 Cohorts 1-4: an additional validated oncogenic driver that could cause resistance to selpercatinib treatment. See Appendix C (Table 11 3) for examples.
- •2.Cohorts 1 to 5: Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]).
- •3.Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of selpercatinib. In addition, no concurrent investigational anti-cancer therapy is permitted.
- •4.Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of selpercatinib.
- •5.Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment.
- •6.Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- •7.Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
- •Patients are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS).
- •8.Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) interval > 470 msec during Screening. Correction of suspected drug-induced QTcF prolongation may be attempted at the Investigator’s discretion if clinically safe to do so.
- •9.Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required.
- •10.Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
- •11.Uncontrolled symptomatic hyperthyroidism or hypothyroidism.
- •12.Uncontrolled symptomatic hypercalcemia or hypocalcemia.
- •13.Pregnancy or lactation.
- •14.Active second malignancy other than minor treatment of indolent cancers.
- •15. History of hypersensitivity to any of the study drug capsule components, or any of the liquid suspension components (for patients that cannot swallow capsules).
研究者
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