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

Sponsor
Oslo University Hospital
Study ID
NCT05725200
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alectinib — DRUG
    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.
  • Cetuximab — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Crizotinib — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Dasatinib — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Everolimus — DRUG
    Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
  • Encorafenib — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Gemcitabine — DRUG
    Dosage form, dosage, frequency and duration are described in the current SMPC and package Insert.
  • Idelalisib — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Larotrectinib — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Methotrexate — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Palbociclib — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Panobinostat — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Pembrolizumab — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Petrozumab — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Trastuzumab — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Talazoparib — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.
  • Venetoclax — DRUG
    Dosage form, dosage, frequency and duration are to be implemented by study investigators as described in the current SMPC and package Insert.

Study Details

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.

Key Dates

Start date
Sep 27, 2022
Status verified
Feb 2023
Primary completion
Dec 31, 2038
Completion
Dec 31, 2040

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Individualized treatment in patients with metastatic colorectal cancer
    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.

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 ]

Central Contacts

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