EUCTR2019-003779-20-DK
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.
ConditionsMetastatic or advanced colorectal cancer (mCRC) with acquired resistance to chemotherapyMedDRA version: 27.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Scandion Oncology A/S
- Enrollment
- 79
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: 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.
Exclusion Criteria
- •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
Investigators
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