ISRCTN18574865进行中（未招募）1 期
A phase Ib TiTE-CRM dose-escalation clinical trial of tolinapant (ASTX660) in combination with standard radical chemoradiotherapy in cervical cancer
niversity of Southampton0 个研究点目标入组 42 人开始时间: 2022年8月30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
- 入组人数
- 42
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38849715/ (added 11/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Histologically confirmed adenocarcinoma or squamous cell carcinoma of the cervix stage IB2/IIB/IIIB
- •2. Suitable for radical treatment with radiotherapy and cisplatin (using a standard dose of 45Gy in 25 daily fractions over 5 weeks with weekly cisplatin 40 mg/m2)
- •3. Adequate haematological parameters:
- •3.1. Haemoglobin = 90 g/l
- •3.2. Neutrophil count = 1.5 x 109/l
- •3.3. Platelets = 100 x 109/l
- •4. Adequate biochemical parameters:
- •4.1. Bilirubin = 1.5 x ULN
- •4.2. AST and ALT =2.0 x ULN
- •4.3. ALP = 2.5 x ULN
- •5. Lipase and Amylase =1.2 x ULN
- •6. GFR Calculated (by Cockcroft-Gault formula or other accepted formula) or measured directly as = 50 mL/min
- •7. Aged 16 years and over
- •8. ECOG Performance Status of 0-1
- •9. Willing and able to give written informed consent
排除标准
- •1. Previous pelvic radiotherapy
- •2. Liver cirrhosis, or chronic liver disease Child-Pugh Class B or C
- •3. Pregnancy or breastfeeding (Women of child bearing potential (WOCBP) must have a negative serum pregnancy test at screening)
- •4. Patients of child-bearing potential who are not able to use a highly effective method of contraception
- •5. Any investigational medicinal product (IMP) within 30 days prior to consent
- •6. Major surgery within 30 days prior to enrolment
- •7. Hypersensitivity to tolinapant, excipients of the drug product, or other components of the study treatment regimen
- •8. Patients with known HIV infection
- •9. Patients with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and the absence of HBsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
- •10. Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable arrhythmias, unstable angina, left bundle branch block, third-degree heart block, pacemakers or congestive cardiac failure (New York Heart Association = grade 2) within 6 months prior to enrolment
- •11. Any patient who has received a live vaccine within 4 weeks of initiation of their treatment (COVID-19 vaccination is allowed)
- •12. Conditions requiring systemic treatment with either corticosteroid (= 20 mg daily prednisolone or equivalent) or other immunosuppressive medications within 14 days of study drug administration.
- •13. Prior anticancer treatments or therapies within the indicated time window prior to the first dose of study treatment (tolinapant), as follows:
- •13.1.Cytotoxic chemotherapy or radiotherapy within 3 weeks prior and any encountered treatment-related toxicities (excepting alopecia) not resolved to Grade 1 or less.
- •13.2. Skin-directed treatments, including topicals and radiation within 2 weeks prior
- •13.3. Monoclonal antibodies within 4 weeks prior and any encountered treatment-related toxicities not resolved to Grade 1 or less
- •13.4. Small molecules or biologics (investigational or approved) within the longer of 2 weeks or 5 half-lives prior to study treatment and any encountered treatment-related toxicities not resolved to Grade 1 or less
- •13.5. At least 6 weeks must have elapsed since CAR-T infusion and subjects must have experienced disease progression, and not have residual circulating CAR-T cells in peripheral blood (based on a local assessment). Any encountered treatment-related toxicities must have resolved to Grade =1.
- •14. Patients taking a QT-prolonging agent
- •15. Use of a concomitant medication which is a strong CYP3A4 inhibitor
- •16. Abnormal left ventricular ejection fraction (LVEF) of <50% on echocardiogram (ECHO)
- •17. History of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy
- •18. Screening 12-lead electrocardiogram (ECG) with measurable QTc interval of =470 msec (according to either Fridericia’s or Bazett’s correction)
- •19. Any other active malignancy
研究者
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