NCT05725200

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Study to Investigate Outcome of Individualized Treatment Based on Pharmacogenomic Profiling & Ex Vivo Drug Sensitivity Testing of Patient-derived Organoids in Patients With Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the effect and side effects of personalized cancer treatment in patients with metastatic colorectal cancer (bowel cancer). All patients included must have metastatic bowel cancer and receive or have received at least two lines of standard chemotherapy. The cancer must not be available for surgery with curative intent.

Detailed description

The purpose of the study is to evaluate individualized systemic anti-cancer treatment of metastatic colorectal cancer (mCRC), selected by a combined pharmacogenomic drug sensitivity profile with a molecular profiling of the tumor tissue and an ex vivo drug sensitivity testing of patient-derived organoids (PDOs). The combined pharmacogenomic drug sensitivity profile will be provided by Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital (OUS) and will be a result of either i) a pre-screening performed in this study or ii) from previous biomarker analyses and drug sensitivity testing of PDOs as part of an ongoing translational research project at Dept. of Molecular Oncology. The combined pharmacogenomic profile will be interpreted by an institutional multidisciplinary tumor board (MTB), and in cases where the MTB strongly suggests that the patient will benefit from one of the interventions offered by this study, the patient will be invited to participate. No formal hypotheses testing will be performed in the study, but it aims to show that it is feasible, in an unselected population of patients with mCRC, to select patients for individualized therapy based on a broad genomic and transcriptomic profiling and ex vivo drug sensitivity testing of cultured PDOs from the patient's own tumor cells, and to provide evidence that a combined pharmacogenomic profile can predict objective antitumor responses to systemic anticancer therapies, including drugs not approved for treatment of patients with mCRC, in the setting of third-line therapy or in later lines. In addition, this study will be part of several translational research projects at the Department of Molecular Oncology.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Alectinib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current Summary of Product Characteristics (SMPC) and package Insert.
DRUG	Cetuximab	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Crizotinib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Dasatinib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Everolimus	Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
DRUG	Encorafenib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Gemcitabine	Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
DRUG	Idelalisib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Larotrectinib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Methotrexate	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Palbociclib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Panobinostat	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Pembrolizumab	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Petrozumab	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Trastuzumab	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Talazoparib	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DRUG	Venetoclax	Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.

Timeline

• Start date: 2022-09-27
• Primary completion: 2038-12-31
• Completion: 2040-12-31
• First posted: 2023-02-13
• Last updated: 2023-02-21

Locations

1 site across 1 country: Norway