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New treatment option for Metastatic Colorectal Cancer
Official title Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT05725200
What this study is testing
What is Alectinib?
Alectinib is an investigational medicine, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Has other clinically significant medical conditions which, in the opinion of the treating physician, makes it undesirable for the patient to...
- 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...
- Has full combined pharmacogenomic profile (genomic and transcriptomic profile of the patients tumor and ex vivo drug sensitivity testing of PDOs from...
- Has measurable or evaluable disease (per RECIST v1.1)
- ECOG performance status 0 or 1
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 Exclusion Criteria:
- 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...
- 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...
- 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...
- 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...
- Meets any of the assigned drug contraindications or other drug-specific exclusion criteria as described in the respective SmPC and in Appendix 16
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.