ACTRN12621001690842招募中2 期
Single arm, open label, signal-seeking phase II study of Sotorasib (AMG-510) in patients with solid tumours harbouring KRAS G12C mutation.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adults, aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any histologic type or an earlier diagnosis of a poor prognosis cancer.
- •2. ECOG performance status 0, 1 or 2;
- •3. Confirmation of KRAS G12C mutation in the tumour tissue by the next generation sequencing (NGS) panel. Patients who have a positive KRAS G12C mutation determined by a recognised assay may be eligible after discussion with the study chair. Patient should have adequate specimen (archival tissue or biopsy) for full molecular screening;
- •4. Confirmation of molecular eligibility by the molecular tumour board;
- •5. Life expectancy greater than or equal to 12 weeks;
- •6. Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists;
- •7. Clinical or radiological progression on or following last anticancer therapy unless such anticancer therapy stopped due to toxicity / treatment intolerance;
- •8. Measurable disease as assessed by RECIST 1.1 or RANO;
- •9. Adequate organ system function as assessed by the following minimal laboratory requirements (within 14 days prior to first administration of study drug):
- •a. Bone marrow function; platelets greater than or equal to 100 × 109/L, ANC greater than or equal to 1.5 × 109/L, and haemoglobin greater than or equal to 90 g/L;
- •b. Liver function; ALT/AST less than or equal to 3 × ULN (in the absence of liver metastases, less than or equal to 5 × ULN for patients with liver involvement) and total bilirubin less than or equal to 1.5 × ULN;
- •10.Renal function; serum creatinine less than or equal to 1.5 × ULN;
- •11.QTc less than or equal to 470 msec (based on average of screening triplicates)
- •12.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •13.Signed, written informed consent to participation in the specific treatment substudy.
排除标准
- •1. Contraindications to investigational product;
- •2. Known history of hypersensitivity to active or inactive components of investigational product;
- •3. History of prior KRAS G12C inhibitor treatment. Prior treatment or participation in a clinical trial with an inhibitor of Mitogen-activated protein kinase (MAPK) or other KRAS-targeting agent is allowed;
- •4. Patients with non-small cell lung cancer (NSCLC) or colorectal cancer are ineligible;
- •5. Specific comorbidities or conditions (e.g., psychiatric) or concomitant medications which may interact with the investigational product;
- •6. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
- •7. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment:
- •a. Radiation therapy, major surgery, or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
- •b. Immunotherapy within 28 days prior to the first dose of study treatment;
- •c. Chemotherapy, biologic therapy or hormonal therapy within 28 days of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer);
- •d. Any unresolved toxicity (greater than CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included;
- •8. Administration of any investigational treatment within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment;
- •9. Use of any of the following agents within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study day 1 that was not reviewed and approved by the principal investigator: (1) known cytochrome P450 CYP3A4 sensitive or P-gp substrates with a narrow therapeutic window, (2) strong inhibitors of CYP3A4, (3) grapefruit juice or grapefruit containing products, (4) strong inducers of CYP3A4 (including St. John's wort)
- •10. For non-central nervous system (CNS) cancers, patients with symptomatic CNS involvement of his/her cancer are excluded. Subjects with stable neurological function, on stable doses of steroids/anti-epileptics over 4 weeks, and with no evidence of CNS progression within 12 weeks prior to screening are eligible;
- •11. Active hepatitis infection based on the following results and/or criteria:
- •a. Positive Hepatitis B Surface Antigen (HBsAg);
- •b. Negative HBsAg with a positive for hepatitis B core antibody (HBcAb);
- •c. Positive Hepatitis C virus antibody: Hepatitis C virus RNA by PCR is necessary. Detectable Hepatitis C virus RNA suggests chronic hepatitis C;
- •12. Known positive test for HIV;
- •13. Prior or concurrent malignancy. For participants with treatment-refractory solid tumours, a concurrent or past history of competing malignancy within 2 years, prior to molecular screening registration, is eligible, unless the competing malignancy is expected to lead to a shorter survival than the index KRAS G12C-harbouring malignancy;
- •14. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Hormonal-based contraception are not allowed. Women of childbearing potential must have a negat
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