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临床试验/JPRN-jRCT2051220060
JPRN-jRCT2051220060招募中1 期

A PHASE 1/2 STUDY OF ORAL LOXO-292 IN PATIENTS WITH ADVANCED SOLID TUMORS, INCLUDING RET-FUSION NON-SMALL CELL LUNG CANCER, MEDULLARY THYROID CANCER, AND OTHER TUMORS WITH INCREASED RET ACTIVITY - LOXO-RET-17001 (J2G-OX-JZJA)

Hokonohara Toshihiro0 个研究点目标入组 25 人开始时间: 2022年7月2日最近更新:
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适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
25
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 18age old 至 ot applicable（—）
性别
All

入选标准

  • •Phase 1 (Dose Escalation and Confirmation of the Recommended Dose in Japan):(Phase II part is currently ongoing)
  • •1. Patients with a locally advanced or metastatic solid tumor.
  • •2. Prior MKIs with anti-RET activity are allowed.
  • •3. A RET gene alteration is not required initially. Once adequate PK is achieved, evidence of a RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation.
  • •4. Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type.
  • •5. 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.
  • •6. Life expectancy of at least 3 months.
  • •7. Adequate hematologic status.
  • •8. Adequate hepatic function.
  • •9. Adequate renal function
  • •Phase 2 (Dose Expansion):
  • •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). However, a positive germline DNA test for a RET gene mutation 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 for tumor type and not previously irradiated.
  • •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.
  • •6. Cohort 5: Patients who otherwise are eligible for:
  • •-Cohorts 1-4 without measurable disease
  • •-MTC not meeting the requirements for Cohorts 3 or 4
  • •-MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with neuroendocrine features/differentiation, or poorly differentiated thyroid cancers with other RET alteration/activation may be allowed with prior Sponsor approval, and
  • •-cfDNA positive for a RET gene alteration not known to be present in a tumor sample.

排除标准

  • •1. Phase 2, Cohorts 1-4, an additional validated oncogenic driver that could cause resistance to selpercatinib treatment.
  • •2. Phase 2, Cohorts 1-5: 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 2 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.

研究者

发起方
Hokonohara Toshihiro

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