Metastatic Colorectal CancerPhase 2EVIDENTNCT05725200
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Alectinib, Cetuximab and Crizotinib in people with Metastatic Colorectal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Alectinib, Cetuximab and Crizotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 27 Sep 2022to 31 Dec 2040
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Has acceptable organ function as defined below. However, as noted below (exclusion criterion 16), drug-specific inclusion/exclusion criteria specified in the Appendix 16/respective SmPC for each agent will take precedence for this and all inclusion criteria:
- 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
Who cannot join
- 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 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.
- Has received previous treatment with the selected study drug for the same malignancy.
- Has a tumor with a genomic variant known to confer resistance to an anti-cancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug.
- Is receiving any other anti-cancer therapies (cytotoxic, biologic, radiation, or hormonal other than for replacement). Participants may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific exclusion criteria (please consult the corresponding SmPC and Appendix 16 for prohibited medication and contraindication/precautions).
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- Is pregnant or breastfeeding or refusing any type of required contraception methods.
- Has known Central Nervous System (CNS) metastases.
- Has preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
- Has left ventricular ejection fraction (LVEF) known to be < 40%.
- Has had a stroke (including TIA) or an acute myocardial infarction within 6 months before the first dose of study treatment.
- Has had acute gastrointestinal bleeding within 1 month of start of treatment
- 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.
- Meets any of the assigned drug contraindications or other drug-specific exclusion criteria as described in the respective SmPC and in Appendix 16
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0379
Tormod K Guren, MDPhD
About this study
Official title: 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
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.
Read the 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
- Being tested
- Alectinib, Cetuximab, Crizotinib, Dasatinib, Everolimus
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
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.
CetuximabDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
CrizotinibDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
DasatinibDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
EverolimusDrug
Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
EncorafenibDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
GemcitabineDrug
Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
IdelalisibDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
LarotrectinibDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
MethotrexateDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
PalbociclibDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
PanobinostatDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
PembrolizumabDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
PetrozumabDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
TrastuzumabDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
TalazoparibDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
VenetoclaxDrug
Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
| Study group | Role | What they receive |
|---|---|---|
| Individualized treatment in patients with metastatic colorectal cancer | Experimental | Interventions 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. Receives: Drug: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Pre-Screening:
Number of participants who achieve a full combined pharmacogenomic profile eligible for treatment decisions either by
- An MTB-nominated treatment provided in the Main Study
- An MTB-nominated treatment considered as SOC
- An MTB-nominated treatment not considered as SOC and not provided in the Main Study
- No MTB-nominated treatment suggested
Measured: Through study completion, approximately 4 years
Main Study: Progression-free survival (PFS) and duration of response (DOR)
Progression-free survival (PFS) and duration of response (DOR) by RECIST 1.1, of participants receiving an MTB-nominated anti-cancer therapy, by calculation of number of days, weeks or years.
Measured: Through study completion, approximately 6 months
Main Study: Overall survival (OS)
OS of participants receiving MTB-nominated anti-cancer therapy, defined as the time from first dose of MTB-nominated treatment to date of death from any cause by calculation of number of days, weeks or years.
Measured: Through study completion, approximately 6 months
Main Study: Safety and tolerability of the different MTB-nominated treatments
Register adverse events (AE) in accordance with CTCAE v 5.1
Measured: 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.
Number of patients who achieve objective response according to RECIST 1.1 from anti-cancer therapy (SOC) in prior lines.
Measured: Through study completion, approximately 6 months
Main Study: Efficacy of MTB-nominated anti-cancer therapy compared to the efficacy of prior lines SOC treatment.
DOR and PFS by RECIST 1.1 of participants receiving an MTB-nominated treatment and from anti-cancer therapy received in prior lines of SOC in each patient, by calculation of number of days, weeks or years.
Measured: Through study completion, approximately 6 months.
Main study: Objective response of an MTB-nominated anti-cancer therapy compared to objective response to the next line(s) SOC treatment.
Number of patients who achieve objective response according to RECIST 1.1 from receiving anti-cancer therapy in the next/later lines.
Measured: Through study completion, approximately 6 months.
Main study: Efficacy of an MTB-nominated anti-cancer therapy compared to the efficacy achieved by the next line(s) of SOC treatment.
DOR and PFS by RECIST 1.1 of participants receiving an MTB-nominated treatment and from anti-cancer therapy in the next/later lines of SOC treatment in each patient, by calculation of number of days, weeks or years.
Measured: Through study completion, approximately 6 months.
Main study: Patient-reported outcome measures.
Describe patient-reported quality of life during the MTB-nominated treatment, registered by EORTC Quality of Life Questionnaire (QLQ)-C30 questionnaire.
The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
Measured: Through study completion, approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start27 Sep 2022
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tormod Kyrre Guren, MD, Oslo University Hospital
- Investigators
- Tormod K Guren, MDPhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725200
- Sponsor's protocol ID
- EVIDENT
- Acronym
- EVIDENT
- Status last verified
- Feb 2023
- First submitted
- 6 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05725200
- Acronym / sponsor ID
- EVIDENT / EVIDENT
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized treatment in patients with metastatic colorectal cancer | Experimental | Drug: 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: VenetoclaxInterventions 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
- 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.
- Has received previous treatment with the selected study drug for the same malignancy.
- Has a tumor with a genomic variant known to confer resistance to an anti-cancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug.
- Is receiving any other anti-cancer therapies (cytotoxic, biologic, radiation, or hormonal other than for replacement). Participants may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific exclusion criteria (please consult the corresponding SmPC and Appendix 16 for prohibited medication and contraindication/precautions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlectinibDosage 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 | Individualized treatment in patients with metastatic colorectal cancer |
| CetuximabDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| CrizotinibDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| DasatinibDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| EverolimusDosage form, dosage, frequency and duration are described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| EncorafenibDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| GemcitabineDosage form, dosage, frequency and duration are described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| IdelalisibDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| LarotrectinibDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| MethotrexateDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| PalbociclibDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| PanobinostatDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| PembrolizumabDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| PetrozumabDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| TrastuzumabDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| TalazoparibDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
| VenetoclaxDosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert. | Drug | Individualized treatment in patients with metastatic colorectal cancer |
Primary outcome
Pre-Screening: Obtain a combined pharmacogenomic profile which can be used to provide a MTB-nominated treatment
Time frame: In average of 3 months
Number of participants that obtain a full combined pharmacogenomic profile which can be used to provide an MTB-nominated treatment in the Main Study.
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.
Time frame: Through study completion, in average 6 months
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.
9 secondary outcomes
Pre-Screening: To obtain a full combined pharmacogenomic profile from a tumor biopsy that is eligible for treatment decisions in a standard oncology practice.
Time frame: Through study completion, approximately 4 years
Main Study: Progression-free survival (PFS) and duration of response (DOR)
Time frame: Through study completion, approximately 6 months
Main Study: Overall survival (OS)
Time frame: Through study completion, approximately 6 months
Main Study: Safety and tolerability of the different MTB-nominated treatments
Time frame: 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.
Time frame: Through study completion, approximately 6 months
Main Study: Efficacy of MTB-nominated anti-cancer therapy compared to the efficacy of prior lines SOC treatment.
Time frame: Through study completion, approximately 6 months.
Main study: Objective response of an MTB-nominated anti-cancer therapy compared to objective response to the next line(s) SOC treatment.
Time frame: Through study completion, approximately 6 months.
Main study: Efficacy of an MTB-nominated anti-cancer therapy compared to the efficacy achieved by the next line(s) of SOC treatment.
Time frame: Through study completion, approximately 6 months.
Main study: Patient-reported outcome measures.
Time frame: Through study completion, approximately 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tormod K Guren, MDPhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alectinib, Cetuximab and Crizotinib in people with Metastatic Colorectal Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tormod K Guren, MDPhD (+4722934000, uxtour@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Screening: Obtain a combined pharmacogenomic profile which can be used to provide a MTB-nominated treatment (time frame: In average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.