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RECRUITINGPHASE2

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

NCT05725200•Oslo University Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pre-screening:
•Has a histologically-proven locally advanced or metastatic adenocarcinoma from colon or rectum
•Has received or is receiving systemic treatment for mCRC
•Has non-resectable metastases and eligible to undergo a radiological-guided core biopsy from at least one metastasis
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Has measurable or evaluable disease (per RECIST v1.1)
•Is capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
•1. Has a histologically-proven locally advanced or metastatic adenocarcinoma from colon or rectum (mCRC)
•2. Has received at least two lines of SOC chemotherapy for mCRC Note: 1) For patients who develop a metastatic relapse \< 6 months after completed total neo-adjuvant treatment in conjunction with a metastasectomy, this treatment will be considered as one line (e.g. first-line) chemotherapy. 2) Patients with the gene RAS wild-type tumors should have received or have been offered and refused prior treatment with antibodies against epidermal growth factor receptor (EGFR) (e.g. in combination with prior lines of chemotherapy) unless it was contraindicated due to underlying conditions or the tumor contains molecular alterations suggested to provide primary resistance to EGFR-targeted therapy.
•3. Has full combined pharmacogenomic profile (genomic and transcriptomic profile of the patients tumor and ex vivo drug sensitivity testing of PDOs from the patient's own tumors cells) from which the MTB suggests a treatment with one of the defined targeted anti-cancer therapies provided this study
+10 more criteria

Exclusion Criteria

•Has other clinically significant medical conditions which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements.
•MAIN STUDY:
•1. Has ongoing toxicity \> CTCAE grade 2, other than peripheral neuropathy and alopecia, related to anti-tumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
•2. Has received previous treatment with the selected study drug for the same malignancy.
•5. Is pregnant or breastfeeding or refusing any type of required contraception methods.
•6. Has known Central Nervous System (CNS) metastases.
•7. Has preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
•8. Has left ventricular ejection fraction (LVEF) known to be \< 40%.
•9. Has had a stroke (including TIA) or an acute myocardial infarction within 6 months before the first dose of study treatment.
•10. Has had acute gastrointestinal bleeding within 1 month of start of treatment
+1 more criteria

Locations (1)

Oslo University Hospital

Oslo, Norway

Key Dates

Start Date

September 27, 2022

Primary Completion Date

December 31, 2038

Completion Date

December 31, 2040

Last Updated

February 21, 2023

Enrollment

ESTIMATED participants

Conditions

Metastatic Colorectal Cancer

Interventions

Alectinib

DRUG

Cetuximab

DRUG

Crizotinib

DRUG

Dasatinib

DRUG

Everolimus

DRUG

Encorafenib

DRUG

Gemcitabine

DRUG

Idelalisib

DRUG

Larotrectinib

DRUG

Methotrexate

DRUG

Palbociclib

DRUG

Panobinostat

DRUG

Pembrolizumab

DRUG

Petrozumab

DRUG

Trastuzumab

DRUG

Talazoparib

DRUG

Venetoclax

DRUG

Contacts

Tormod K Guren, MDPhD

CONTACT

+4722934000 uxtour@ous-hf.no

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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