An open phase II study of safety, tolerability, highest tolerable dose and anti-tumor effect of SCO-101 in combination with FOLFIRI as a safe and effective treatment of patients with widespread colorectal cancer who has developed treatment resistance to treatment with FOLFIRI
- Conditions
- Metastatic or advanced colorectal cancer (mCRC) with acquired resistance to chemotherapy.MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003779-20-ES
- Lead Sponsor
- Scandion Oncology A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 35
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 only: with or without BRAF, KRAS or repair enzyme mutations.
B. Stage 2 and stage 3 only: without known BRAF, KRAS or repair enzyme mutations
5. A. Stage 1 only: Documented?progressive disease on?FOLFIRI treatment regimen?(with or without antiangiogenetic and EGFR inhibitory biological treatment)
5. B. Stage 2 and stage 3 only: Documented?progressive disease with a prior benefit (SD for more than 16 weeks, or CR or PR) on FOLFIRI treatment regimen (with or without antiangiogenetic and EGFR inhibitory biological treatment)
6. Maximum reduction of 33% in prior dose of FOLFIRI.
7. No indication for treatment with an oxaliplatin-containing treatment regimen. The patient may have received oxaliplatin treatment after treatment with FOLFIRI.
8. A. Stage 1 only: Evaluable disease by CT scan or MRI
B. Stage 2 and stage 3 only: Measurable disease by CT scan or MRI, according to RECIST 1.1.??
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??
• Creatinine clearance within normal limits.?
• Adequate blood clothing function as defined by the International
Normalized Ratio (INR) = 1.2;
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.
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. Concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) 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 irinotecan, 5FU or capecitabine
12.Pregnant women or women who are breastfeeding.?
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method