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A Phase 2 Trial of SCO-101 in Combination With FOLFIRI for Patients With Metastatic Colorectal Cancer (mCRC) With Acquired Resistance to FOLFIRI

NCT04247256 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-03-02

No results posted yet for this study

Summary

This study evaluates the combination of SCO-101 to FOLFIRI for the treatment of metastatic colorectal cancer patients who have developed resistance to FOLFIRI treatment. The study is divided in two parts, where the first part evaluates the safety and toxicity of increasing doses of SCO-101 in combination with FOLFIRI at the same dose as the patient has previously developed resistance to. The second part of the study evaluates the safety and efficacy of the combination of FOLFIRI and SCO-101 at the dose level established in the first part.

Conditions

Interventions

DRUG

FOLFIRI Protocol

FOLFIRI standard treatment on day 5 to 7 (both days included) of a 14 day period. repeated bi-weekly

DRUG

SCO-101

Investigational Medicinal Product, oral tablet administered on day 1 to 6 (both days included) of a 14 day period. repeated bi-weekly

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Scandion Oncology A/S

    lead INDUSTRY

Principal Investigators

  • Jacob Hagen Vasehus Schou, MD · Herlev and Gentofte Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Denmark
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247256 on ClinicalTrials.gov