NCT00526838终止1 期
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Exelixis
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a histologically confirmed solid tumor that is metastatic or unresectable, lymphoma, or multiple myeloma, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. Subjects treated at the MTD (once-weekly) must have a diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma, non-small-cell lung cancer (NSCLC), or small cell lung cancer (SCLC). Certain other eligibility requirements must also be met.
- •The subject has disease that is assessable by tumor marker, clinical laboratory, physical, or radiologic means.
- •The subject is ≥18 years old.
- •The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •The subject has adequate organ and marrow function.
- •The subject is capable of understanding the informed consent document and has signed the informed consent document.
- •Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
排除标准
- •The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, investigational agent, or hormones) within 14 days before the first dose of study drug.
- •The subject has received radiation to >25% of his or her bone marrow within 30 days of treatment with XL
- •The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from adverse events (AEs) due to investigational or other agents administered more than 14 days prior to study enrollment.
- •The subject has a primary brain tumor. Subjects with brain metastases are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
- •The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •The subject has a psychiatric illness or social situation that would limit compliance with study requirements.
- •The subject is pregnant or breastfeeding.
- •The subject is known to be positive for the human immunodeficiency virus (HIV).
- •The subject has a known allergy or hypersensitivity to components of the XL228 formulation.
- •The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
研究组 & 干预措施
1
Experimental
once-weekly dosing
干预措施: XL228 (Drug)
2
Experimental
twice-weekly dosing
干预措施: XL228 (Drug)
结局指标
主要结局
To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.
时间窗: Assessed at periodic visits
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
时间窗: Assessed at periodic visits
次要结局
- To evaluate plasma pharmacokinetics of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.(Assessed at periodic visits)
- To evaluate preliminary safety and efficacy of XL228 when administered at the once-weekly MTD(Assessed at periodic visits)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
1 期
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)Hemophilia AHealthy ParticipantsHemophilia AHemophilia BHemophilia BNCT06349473Equilibra Bioscience LLC31
招募中
1 期
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 MutationLocally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 MutationNCT06501625Institut de Recherches Internationales Servier52
已完成
1 期
A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese ParticipantsHealthy VolunteersNCT05405543Bristol-Myers Squibb36
已完成
1 期
A Study of LY3532226 in Participants With ObesityObesityNCT06557356Eli Lilly and Company132
已完成
1 期
Study of XL647 Administered Orally Daily to Patients With Solid TumorsCancerNCT00336765Kadmon Corporation, LLC31