Actively Recruiting
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
Led by Oslo University Hospital · Updated on 2023-02-21
40
Participants Needed
1
Research Sites
952 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a histologically-proven locally advanced or metastatic adenocarcinoma from colon or rectum
- Has received at least two lines of standard chemotherapy for metastatic colorectal cancer
- Has non-resectable metastases and is eligible for a radiological-guided core biopsy from at least one metastasis
- Has measurable or evaluable disease according to RECIST v1.1 criteria
- Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Is capable of giving signed informed consent complying with study requirements
- Has full combined pharmacogenomic profile from genomic, transcriptomic tumor profiling and ex vivo drug sensitivity testing of PDOs
- For orally administered drugs, is able to swallow and tolerate oral medication with no known malabsorption syndrome
- Women of child-bearing potential and men agree to use adequate contraception during study participation and up to 7 months after
- Has acceptable organ function including neutrophil count ≥ 1.5/nL, hemoglobin > 10 g/dL, platelets > 100/nL, bilirubin < 1.5 x ULN, AST and ALT < 2.5 x ULN (or < 5 x ULN if hepatic metastases), and creatinine clearance ≥ 50 mL/min/1.73 m2
You will not qualify if you...
- Has other significant medical conditions making participation undesirable or compliance difficult
- Has ongoing toxicity above CTCAE grade 2 from recent anti-tumor treatment (except peripheral neuropathy and alopecia); peripheral neuropathy grade 3 or higher is excluded
- Has previously received treatment with the selected study drug for the same cancer
- Has a tumor with genomic variants conferring resistance to study drugs, excluding those drugs from treatment options
- Is receiving other anti-cancer therapies besides study treatment, except some anticoagulants
- Is pregnant, breastfeeding, or refuses required contraception
- Has known central nervous system metastases
- Has preexisting cardiac conditions such as uncontrolled angina, arrhythmias, or symptomatic heart failure
- Has left ventricular ejection fraction below 40%
- Has had a stroke or heart attack within 6 months before starting study treatment
- Has had acute gastrointestinal bleeding within 1 month before treatment
- Meets any drug-specific contraindications or exclusion criteria described in the drug information or study appendices
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0379
Actively Recruiting
Research Team
T
Tormod K Guren, MDPhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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