Investigation of SCO-101 in Combination With FOLFIRI for Patients With Metastatic Colorectal Cancer (mCRC) With Acquired Resistance to FOLFIRI
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a multi-center, open label, dose escalation, Phase 2 study of SCO-101 in combination with FOLFIRI in up to 50 mCRC patients. Cohorts of FOLFIRI-resistant mCRC patients will be treated with SCO-101 in combination with FOLFIRI . Patients to be enrolled should previously have had either complete response (CR), partial response (PR), or stable disease (SD) (>16 weeks) on FOLFIRI. The study is separated in two parts. Part 1 is a dose escalation part with a standard 3+3 design, designed to evaluate the safety and toxicity of the combination of SCO-101 and FOLFIRI, and to identify the maximum tolerated dose (MTD). A maximum of 5 cohorts have been planned. Starting dose of SCO-101 is 150 mg (cohort 1) and maximum dose is 350 mg (cohort 5). Part 2 is the efficacy part, where patients are treated with the MTD dose identified in the first part and evaluated for efficacy and safety of the combination SCO-101 plus FOLFIRI.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a multi-center, open label, dose escalation, Phase 2 study of SCO-101 in combination with FOLFIRI in up to 50 mCRC patients. All patients included have previously had effect from treatment with FOLFIRI, but have now progressed (i.e. treatment failure due to acquired resistance). FOLFIRI is a...
This is a multi-center, open label, dose escalation, Phase 2 study of SCO-101 in combination with FOLFIRI in up to 50 mCRC patients. All patients included have previously had effect from treatment with FOLFIRI, but have now progressed (i.e. treatment failure due to acquired resistance). FOLFIRI is a key anti-cancer chemotherapeutic combination in the treatment of several solid tumor cancers, e.g. colorectal cancer. Cancer resistance to FOLFIRI exposure is a well known phenomenon and can often be attributed to upregulation of cellular efflux pumps, e.g. ATP-Binding Cassette (ABC)G2 and ABCB1, involved in the efflux of the chemotherapeutic agents from the cancer cells and resulting in treatment failure. SCO-101 is an inhibitor of ATP-Binding Cassette (ABC) efflux pumps and SRPK1 kinase which is responsible for phosphorylation of splicing factors, a key element involved in tumour growth. The combination of SCO-101 with FOLFIRI is expected to inhibit the active efflux of chemotherapy molecules from the cancer cell thereby re-sensitizing it to the chemotherapeutic agents.
Tracking Information
- NCT #
- NCT04247256
- Collaborators
- TFS Trial Form Support International AB
- Investigators
- Principal Investigator: Jacob Hagen Vasehus Schou, MD Herlev and Gentofte Hospital
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