An open-label phase II prospective clinical trial to investigate safety, tolerability, maximum tolerated dose and anti-tumor effect for SCO-101 in combination with FOLFIRI as a safe and efficient treatment modality in metastatic or advanced colorectal cancer (mCRC) patients with acquired FOLFIRI resistant cancer disease.

Scandion Oncology A/S0 个研究点目标入组 79 人开始时间: 2019年10月2日最近更新: 2024年7月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Scandion Oncology A/S
入组人数: 79

研究概览入排标准研究者记录与标识符相似试验

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

•1. Ability to understand and willingness to provide written informed consent before any trial-related activities.
•2. Age 18 years or older.
•3. Histologically verified colorectal adenocarcinoma;
•4. Non resectable mCRC in patients:
•A. Stage 1: with or without BRAF, KRAS or repair enzyme mutations.
•B. Stage 2: without BRAF, KRAS or known repair enzyme mutations
•C. Stage 3: with or without BRAF, RAS or repair enzyme mutations, actual status to be confirmed prior to enrollment
•5. Previous treatment and documented progressive disease with irinotecan and 5-FU (including 5-FU based analogs, e.g. capecitabine) based chemotherapy regimens (with or without antiangiogenetic and EGFR inhibitory biological treatment)
•6. Maximum reduction of 33% in prior dose of FOLFIRI
•7. Previous treatment with an oxaliplatin-containing treatment regimen and no indication for re-challenge with oxaliplatin. The patient can received oxaliplatin treatment before and/or after treatment with FOLFIRI.
•8. A. Stage 1 and 3 only: Evaluable disease by CT scan or MRI
•B. Stage 2 only: Measurable disease by CT scan or MRI, according to RECIST
•9. Performance status of ECOG = 1.
•10. Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy or treatment with cytotoxic or biologic agents.
•11. = 2 weeks must have elapsed since any prior surgery
•12. Adequate conditions as evidenced by the following clinical laboratory values:
•Absolute neutrophils count (ANC) = 1.5 x 10^9/L
•Haemoglobin is at least 6,0 mmol/L
•Platelets = 100 x 10^9 /L
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN
•Total serum bilirubin = 1.0 ULN
•Alkaline phosphatase = 2.5 x ULN
•Creatinine = 1.5 ULN
•Normal kidney function defined by the centers with the method usually employed locally i.e. either creatinine (= 1.5 ULN) or calculated creatinine clearance or eGFR within normal limits determined according to local standards.
•Adequate blood clotting function as defined by the International Normalized Ratio (INR) = 1.5
•13. Life expectancy equal to or longer than 3 months.
•14.Sexually active males and females of child-producing potential must use adequate highly effective contraception during the trial and for at least 6 months after the last dose of study drug. Moreover, monthly pregnancy testing will be done during the treatment phase of the trial. (Highly effective contraceptive measures are methods that can achieve a failure rate of less than 1% per year. These include: intrauterine devices, hormonal contraceptives associated with inhibition of ovulation (oral, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). A vasectomised partner or sexual abstinence may be regarded as highly effective methods, if this is the usual and preferred lifestyle of the subject. Sterilised or infertile subjects are exempt from the requirement to use contraception. In order to be considered sterile or infertile, subjects must generally have undergone surgical sterilisation (vasectomy/bilateral salpingectomy, hysterectomy and bilateral oophorectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrolment. Double-barrier methods (condom+cervical cap with spermicide) are not considered highly effective)
•15. Signed informed consent.
•16. Patients are only eligible for inclusion if no further on label treatment alternatives are avail

排除标准

•1. Concurrent chemotherapy, radiotherapy, or other investigational drugs during study period.
•2. Malabsorption syndrome or previous surgeries with resection of the stomach or small intestine, whereby absorption of SCO-101 may be affected. This includes patients with ileostomy.
•3. Difficulty in swallowing tablets.
•4. Clinical symptoms of CNS metastases requiring steroids.
•5. Any active infection requiring parenteral or oral antibiotic treatment.
•6. Known HIV positivity.
•7. Known active hepatitis B or C.
•8. Clinical significant (i.e. active) cardiovascular disease:
•Stroke within = 6 months prior to day 1
•Transient ischemic attach (TIA) within = 6 months prior to day 1
•Myocardial infarction within = 6 months prior to day 1
•Unstable angina
•New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF)
•Serious cardiac arrhythmia requiring medication
•9. Mental status is not fit for clinical study or CNS disease including symptomatic epilepsy.
•10. Other medications or conditions that in the Investigator’s opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results. Other severe medical conditions, including serious heart disease, unstable diabetes, uncontrolled hypercalcaemia, clinically active infections or previous organ transplants. Participation in another clinical trial with experimental medication within 30 days prior to registration.
•11. Known hypersensitivity to SCO-101, irinotecan, 5FU or structurally similar drugs (e.g. capecitabine), leucovorin and G-CSF.
•12.Pregnant women or women who are breastfeeding.
•13.Patients with known Dihydropyrimidine dehydrogenase (DPD) deficiency

研究者

发起方

Scandion Oncology A/S

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