EUCTR2019-003779-20-ES
Active, not recruiting
Phase 1
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.
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Scandion Oncology A/S
- Enrollment
- 35
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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??
Investigators
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