A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors

oxo Oncology Inc0 个研究点目标入组 151 人开始时间: 2016年6月7日最近更新: 2016年6月13日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 151

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Locally-advanced or metastatic malignancy with an NTRK1, NTRK2 or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
•2. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
•3. Subjects must have at least one measurable lesion as defined by RECIST 1.1 (Eisenhauer 2009). Subjects without RECIST measurable disease (e.g., evaluable disease only) will be eligible for enrollment to Cohort 8, regardless of tumor type. Subjects in Cohort 7 (primary CNS tumors) should meet the following criteria:
•a. Have received prior treatment including radiation and/or chemotherapy, with radiation completed > 12 weeks prior to C1D1 of therapy, as recommended or appropriate for that CNS tumor type.
•b. Have ? 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging [MRI] and evaluable by RANO criteria), with the size of at least one of the measurable lesions ? 1 cm in each dimension and noted on more than one imaging slice.
•c. Imaging study performed within 28 days before enrollment while on stable dose steroid medication for at least 5 days immediately before and during the imaging study.
•4. At least 18 years of age.
•5. Eastern Cooperative Oncology Group (ECOG) score of ? 2.
•6. Archived tumor tissue. If archival tissue is known to not be available then an on-study tumor biopsy should be attempted if it can be safely performed.
•7. Adequate organ function as defined by the following criteria:
•a. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 × upper limit of normal (ULN), or AST and ALT < 5 × ULN if liver function abnormalities are due to underlying malignancy.
•b. Total bilirubin < 2.5 × ULN, except in the setting of biliary obstruction. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.
•c. Serum creatinine < 2.0 × ULN OR an estimated glomerular filtration rate ? 30 mL/minute using the Cockroft-Gault formula:
•(140 ? age) x body weight (kg) × 0.85 (if female)
•serum creatinine (mg/dL) × 72
•8. Ability to swallow capsules, comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
•9. Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion.
•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 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 76

排除标准

•1. Investigational agent or anticancer therapy within 2 weeks prior to planned start of LOXO-101 or 5 half-lives, whichever is shorter, and with recovery of clinically significant toxicities from that therapy.
•Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain metastases are eligible to participate in the study). Subjects with primary CNS tumors are eligible.
•3. Uncontrolled concurrent malignancy that would limit assessment of efficacy of LOXO-101.
•4. Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease or other systemic disease that would limit compliance with study procedures.
•5. Malabsorption syndrome or other condition affecting oral absorption.
•6. Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation.
•7. Pregnancy or lactation.

研究者

发起方

oxo Oncology Inc

相似试验

进行中（未招募）

1 期

A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive TumorsSolid TumorsMedDRA version: 19.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864

EUCTR2015-003582-28-FRoxo Oncology Inc151

进行中（未招募）

1 期

A study to learn how well the drug larotrectinib works in adults with different solid cancers with a change in the genes called NTRK fusioSolid tumors harboring NTRK fusionMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 23.0Level: PTClassification code 10081769Term: NTRK gene fusion overexpressionSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

EUCTR2015-003582-28-SEBayer Consumer Care AG214

进行中（未招募）

1 期

A Phase 2 Basket Study of the Oral TRK Inhibitor larotrectinib in Subjects with NTRK Fusion-Positive TumorsSolid TumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864

EUCTR2015-003582-28-CZBayer Consumer Care AG125

进行中（未招募）

1 期

EUCTR2015-003582-28-PLBayer Consumer Care AG214

进行中（未招募）

1 期

EUCTR2015-003582-28-DKBayer Consumer Care AG125