EUCTR2021-003799-15-ES进行中（未招募）1 期
A Randomized, Double-blind Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of ASC-201 Plus Trifluridine/Tipiracil Compared With Trifluridine/Tipiracil in Patients With Advanced Gastric Cancer in a Third Line Treatment Setting After an Initial Dose Escalation Phase
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 139
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
- •Patients are eligible to be included in the study only if all of the following criteria apply:
- •1. Capable of giving signed informed consent as described in Appendix 2 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •2. Male or female patients must be =18 years of age, at the time of signing the informed consent.
- •3. Patients with histologically or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma.
- •4. Are candidates for trifluridine/tipiracil therapy, having metastatic gastric gastroesophageal junction adenocarcinoma, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
- •5. Has measurable disease based on RECIST v.1.1 as determined by the site study team.
- •Please see protocol v2.0 for full inclusion criteria.
- •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 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Patients are excluded from the study if any of the following criteria apply:
- •1. History of previous malignancy other than gastric cancer within the last 2 years except basal cell carcinoma or carcinoma in situ in solid organ.
- •2. Presence of chronic inflammatory bowel disease and/or bowel obstruction.
- •3. Homozygous for the uridine diphosphate glucuronosyltransferase (UGT1A1) *28 allele (Gilbert's syndrome) or otherwise known to have reduced UGT1A1 activity (applies for Phase 1 only).
- •4. Known central nervous system or brain metastases, unless previously treated and stable for 3 months.
- •5. Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months.
- •6. Any other ongoing significant disease, or condition other than gastric cancer as judged by the Investigator to compromise the patients' ability to complete this study, eg but not limited to an active infection (including active hepatitis B, hepatitis C or HIV infections), unresolved pneumonia/pneumonitis, uncontrolled diabetes, poorly controlled hypertension or other cardiovascular disease.
- •7. Previously received irinotecan treatment for gastric cancer.
- •8. Receiving concomitant medication that are:
- •(a) Strong inhibitors (eg, ketoconazole) of CYP3A4, OR
- •(b) Strong inducers (eg, rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort) of CYP3A4, OR
- •(c) Substrates of human thymidine kinase (eg, zidovudine).
- •9. Receiving any other investigational agent within 4 weeks prior to Screening.
- •10. Enrolled in another clinical study with an IMP.
- •Please see protocol v2.0 for full exclusion criteria.
研究者
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