KCT0004071招募中未知
Phase II, single-arm study of AZD1775 in combination with paclitaxel, in advanced gastric adenocarcinoma patients harboring TP53 mutation as a second-line chemotherapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Provision of fully informed consent prior to any study specific procedures.
- •2. Patients must be =20 years of age.
- •3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after first-line therapy.
- •- The 1st line regimen must have contained doublet 5-fluoropyrimidine or platinum based regimen.
- •(Subjects with a history of receiving adjuvant chemotherapy to XELOX regimen could be acceptable to Irinotecan regimen as 1st line therapy)
- •- Relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doublet 5-fluoropyrimidine and platinum-based regimen could be considered as 1st line therapy.
- •- Acceptable prior chemotherapy regimens for this protocol are chemotherapy regimens that include Immune Target agent therapy. (such as a pembrolizumab, ramucirumab etc)
- •4. Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
- •5. Provision of tumor sample (from either a resection or biopsy)
- •6. Patients with p53 mutation through the VIKTORY trial. (see addendum for the VIKTORY trial).
- •7. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- •8. ECOG performance status 0-1
- •9. Patients must have a life expectancy = 3 months from proposed first dose date.
- •10. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
- •- Haemoglobin =9.0 g/dL (transfusion allowed)
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- White blood cells (WBC) > 3 x 109/L
- •- Platelet count =100 x 109/L (transfusion allowed)
- •- Total bilirubin = 1.5 x institutional upper limit of normal (ULN)
- •- AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be = 5x ULN
- •- Serum creatinine =1.5 x institutional ULN
- •11. At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
- •12. Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.
- •13. Female patients who are not of child-bearing potential and fertile females of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to the start of study treatment.
- •14. Male patients should be willing to abstain or use barrier contraception (i.e., condoms) for the duration of the study drug exposure and for 3 months after study treatment discontinuation
排除标准
- •1. More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.
- •2. Any previous treatment with P53 inhibitors (small molecules)
- •3. Any previous treatment with paclitaxel
- •4. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for =5 years.
- •5. HER2 positive patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)
- •6. Patients unable to swallow orally administered medication.
- •7. Treatment with any investigational product during the last 14 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).
- •8. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denusomab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
- •9. Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
- •10. With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
- •11. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
- •12. Resting ECG with measurable QTcB > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- •13. Patients with cardiac problem as follows: uncontrolled hypertension (BP =150/95 mmHg despite medical therapy) Left ventricular ejection fraction <55% measured by echocardiography, Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest , Symptomatic heart failure (NYHA grade II-IV), Prior or current cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment
- •14. Ophthalmological conditions as follows:Intra-ocular pressure >21 mmHg, or uncontrolled glaucoma (irrespective of intra-ocular pressure), Current or past history of central serous retinopathy or retinal vein occlusion
- •15. Female patients who are breast-feeding or child-bearing
- •16. Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •17. Major surgical procedures =28 days of beginning study treatment, or minor surgical procedures =7 days. No waiting period required following port-a-cath or other central venous access placement.
- •18. Patient has an inability to swallow oral medications. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).
研究者
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