EUCTR2021-005604-35-Outside-EU/EEA进行中（未招募）1 期
CI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of JNJ-42756493 (Erdafitinib) in Patients With Tumors Harboring FGFR1/2/3/4 Alterations
ational Cancer Institute (NCI)0 个研究点开始时间: 2022年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621B based on the presence of an actionable mutation.
- •Patients must have a body surface area >= 0.53 m^2 at enrollment
- •Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two
- •perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
- •Note: The following do not qualify as measurable disease:
- •- Malignant fluid collections (e.g., ascites, pleural effusions)
- •- Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
- •- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
- •- Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
- •- Previously radiated lesions that have not demonstrated clear progression post radiation
- •- Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 49
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breast-feeding women will not be entered on this study due to risks of
- •fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must
- •be obtained in girls who are post-menarchal. Males or females of reproductive
- •potential may not participate unless they have agreed to use an effective
- •contraceptive method, while receiving study treatment and for 3 months after the
- •last dose of JNJ-42756493 (erdafitinib). Male subjects (with a partner of childbearing
- •potential) must use a condom with spermicide when sexually active and must
- •not donate sperm from the first dose of study drug until 5 months after the last dose
- •of study drug.
- •Concomitant Medications
- •- Corticosteroids: Patients receiving corticosteroids who have not been on
- •a stable or decreasing dose of corticosteroid for at least 7 days prior to
- •enrollment are not eligible. If used to modify immune adverse events
- •related to prior therapy, = 14 days must have elapsed since last dose of
- •corticosteroid (See Section 4.1.6.1.d).
- •- Investigational Drugs: Patients who are currently receiving another
- •investigational drug are not eligible.
- •- Anti-cancer Agents: Patients who are currently receiving other anti-cancer
- •agents are not eligible.
- •- Anti-GVHD agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to
- •prevent graft-versus-host disease post bone marrow transplant are not
- •eligible for this trial.
- •- CYP3A4 Agents: Patients who are currently receiving drugs that are
- •strong inducers or inhibitors of CYP3A4 are not eligible.
- •- CYP2C9 Agents: Patients who are currently receiving drugs that are
- •moderate to strong inducers or inhibitor of CYP2C9 are not eligible.
- •- P-glycoprotein: Patients who are currently receiving drugs that are potent
- •inhibitors of p-glycoprotein are not eligible.
- •Infection: Patients who have an uncontrolled infection are not eligible.
- •Patients who have received a prior solid organ transplantation are not eligible.
- •Patients who in the opinion of the investigator may not be able to comply with the
- •safety monitoring requirements of the study are not eligible.
- •A history of cardiovascular diseases: Unstable angina, myocardial infarction, or
- •known congestive heart failure Class IIIV within the preceding 12 months;
- •cerebrovascular accident or transient ischemic attack within the preceding 3
- •months, pulmonary embolism within the preceding 2 months.
- •A history of any of the following: sustained ventricular tachycardia, ventricular
- •fibrillation, Torsades de Pointes, cardiac arrest, Mobitz II second degree heart
- •block or third degree heart block; known presence of dilated, hypertrophic, or
- •restrictive cardiomyopathy.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active
- •infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
- •arrhythmia, or psychiatric illness/social situations that would limit compliance
- •with study requirements.
- •Patients with known significant ophthalmologic conditions (uncontrolled
- •glaucoma, history of retinal vein occlusion or retinal detachment, excluding
- •patients with longstanding findings secondary to existing conditions) are not
研究者
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