Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
EVIDENT
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2022
CompletedFirst Submitted
Initial submission to the registry
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2040
February 21, 2023
February 1, 2023
16.3 years
January 6, 2023
February 16, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Pre-Screening: Obtain a combined pharmacogenomic profile which can be used to provide a MTB-nominated treatment
Number of participants that obtain a full combined pharmacogenomic profile which can be used to provide an MTB-nominated treatment in the Main Study.
In average of 3 months
Main Study: To evaluate the anti-tumor activity, measured as objective response rate (ORR) of MTB-nominated therapies with drugs not approved or implemented in standard of care (SOC) for treatment of mCRC.
Number of patients who achieve objective response according RECIST 1.1 in the total study population and each study drug cohort of MTB-nominated therapies with drugs not approved or implemented SOC for treatment of mCRC.
Through study completion, in average 6 months
Secondary Outcomes (9)
Pre-Screening: To obtain a full combined pharmacogenomic profile from a tumor biopsy that is eligible for treatment decisions in a standard oncology practice.
Through study completion, approximately 4 years
Main Study: Progression-free survival (PFS) and duration of response (DOR)
Through study completion, approximately 6 months
Main Study: Overall survival (OS)
Through study completion, approximately 6 months
Main Study: Safety and tolerability of the different MTB-nominated treatments
Through study completion, approximately 6 months
Main Study: Objective response of an MTB-nominated anti-cancer therapy compared to objective response to the prior line(s) SOC treatment.
Through study completion, approximately 6 months
- +4 more secondary outcomes
Study Arms (1)
Individualized treatment in patients with metastatic colorectal cancer
EXPERIMENTALInterventions with anti-cancer drugs having marketing authorisation in Norway will be used in this study. The intervention will be study drugs as monotherapy or treatment with approved combinations. This trial will facilitate access to potentially effective interventions to which they would otherwise not have access.
Interventions
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.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- Has a histologically-proven locally advanced or metastatic adenocarcinoma from colon or rectum (mCRC)
- 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.
- 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
- Has measurable or evaluable disease (per RECIST v1.1)
- ECOG performance status 0 or 1
- For orally administered drugs, the participant must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Because of the risks of drug treatment to a developing fetus, women of child-bearing potential and men must agree to use adequate contraception in accordance with the respective SmPC and as listed in Appendix 4 for the duration of study participation, and up to 7 months following completion of study therapy. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or completely abstain from sexual intercourse.
- Absolute neutrophil count ≥ 1.5/nL (nL = nano Litre)
- Hemoglobin \> 10 g/dL
- Platelets \> 100/nL
- Total bilirubin \< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase AST (SGOT) and alanine aminotransferase ALT(SGPT) \< 2.5 x institutional upper limit of normal (ULN) (or \< 5 x ULN in patients with known hepatic metastases)
- Calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, 0379, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tormod K Guren, MDPhD
Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 6, 2023
First Posted
February 13, 2023
Study Start
September 27, 2022
Primary Completion (Estimated)
December 31, 2038
Study Completion (Estimated)
December 31, 2040
Last Updated
February 21, 2023
Record last verified: 2023-02