NL-OMON54586招募中2 期
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1) - TRIDENT-1
Turning Point Therapeutics (a wholly owned subsidiary of Bristol Myers Squibb company)0 个研究点目标入组 23 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
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
- 18 至 99（—）
入选标准
- •- Histologically or cytologically confirmed diagnosis of locally advanced, or
- •metastatic solid tumor (including primary CNS tumors) that harbors a ROS1 or
- •NTRK1-3 gene fusion.
- •- Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by
- •either a) an approved medical device OR b) a non-approved medical device (for
- •details please see the protocol).
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- •- Age >= 12 (or age >=20 as required by local regulation)
- •Sponsor confirms that only persons 18 years of age and older will be enrolled
- •in the Netherlands
- •- At least 1 measurable target lesion according to RECIST (v1.1) prospectively
- •confirmed by Blinded Independent Central Radiology Review (BICR), selected by
- •the Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable target
- •lesion >= 10 mm as defined by RECIST (v1.1) are eligible.
排除标准
- •1. Concurrent participation in another therapeutic clinical trial. 2.
- •Symptomatic brain metastases or leptomeningeal involvement. 3. History of
- •previous cancer requiring therapy within the previous 2 years, except for
- •squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma
- •that has been completely resected. 4. Major surgery within 4 weeks of start of
- •repotrectinib treatment. Radiation therapy (except palliative to relieve bone
- •pain) within 2 weeks of study entry. Palliative radiation (<=10 fractions) must
- •have been completed at least 48 hours prior to study entry. 5. Clinically
- •significant cardiovascular disease (either active or within 6 months prior to
- •enrollment): myocardial infarction, unstable angina, coronary/peripheral artery
- •bypass graft, symptomatic congestive heart failure (New York Heart Association
- •Classification Class >= II), cerebrovascular accident or transient ischemic
- •attack, symptomatic bradycardia, requirement for anti-arrhythmic medication.
- •Ongoing cardiac dysrhythmias of CTCAE grade >=2. 6. Any of the following cardiac
- •criteria: · Mean resting corrected QT interval (ECG interval measured from the
- •onset of the QRS complex to the end of the T wave) for heart rate (QTc) > 470
- •msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc
- •value · Any clinically important abnormalities in rhythm, conduction or
- •morphology of resting ECG (e.g., complete left bundle branch block, third
- •degree heart block, second degree heart block, PR interval > 250 msec) · Any
- •factors that increase the risk of QTc prolongation or risk of arrhythmic events
- •such as heart failure, hypokalemia, congenital long QT syndrome, family history
- •of long QT syndrome, or any concomitant medication known to prolong the QT
- •interval 7. Known active infections requiring ongoing treatment (bacterial,
- •fungal, viral including HIV positivity). 8. Gastrointestinal disease (e.g.,
- •Crohn*s disease, ulcerative colitis, or short gut syndrome) or other
- •malabsorption syndromes that would impact on drug absorption. 9. Peripheral
- •neuropathy, paresthesia, dizziness, dysgeusia, muscle weakness, ataxia grade
- •>=2. 10. History of extensive, disseminated, bilateral, or presence of CTCAE
- •grade 3 or 4 interstitial fibrosis or interstitial lung disease including a
- •history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia,
- •interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis.
- •Subjects with history of prior radiation pneumonitis are not excluded. 11.
- •Other severe acute or chronic medical or psychiatric condition or laboratory
- •abnormality that may increase the risk associated with study participation or
- •study drug administration, or that may interfere with the interpretation of
- •study results and, in the judgment of the Investigator, would make the subject
- •inappropriate for entry into this study, or could compromise protocol
- •objectives in the opinion of the Investigator and/or Turning Point
- •Therapeutics. 12. Current use or anticipated need for drugs that are known to
- •be strong CYP3A inhibitors or inducers as listed in Appendix 5. 13. Additional
- •exclusion criteria for subjects participating in the midazolam DDI sub-study:
- •in addition to the strong CYP3A inhibitors or inducers listed in Appendix 5,
- •subjects should not be taking any mode
研究者
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A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 RearrangementsPatients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 RearrangementsJPRN-jRCT2011210009Minal Mehta, MBBS20