TARGETed Therapy Drug MONITOring in DIGestive Oncology

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 18 years or over

Regorafenib for GIST, mCRC, and HCC,

Everolimus for gepNET,

Sunitinib for pNET or GIST,

Disqualifiers

Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied

Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and peripheral neuropathy

Prior treatment with the same MKI molecule(s) planned to be given in the cohort. If different MKI molecules (from the one(s) planned in the study) have been previously taken, a wash out period of 2 weeks before treatment should be observed.

Other invasive malignancies either currently active or active in the last 3 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sampling to build population pharmacokinetics model

    Other intervention

    Determine for each drug plasmatic exposure (Css, trough) through the PopPK model. Concentrations measured at the following time points: * 1 month after the first treatment administration * 2 months after the first treatment administration * In case of progression * In case of severe toxicities (AESI) related to the drug received

Treatment groups

330 Participants
are divided into 5 treatment groups
Group A: Regorafenib - mCRC, GIST, HCCExperimental treatment 1 intervention
Group B: Everolimus - gepNETExperimental treatment 1 intervention
Group C: Sunitinib - pNET, GISTExperimental treatment 1 intervention
Group D: Cabozantinib - HCCExperimental treatment 1 intervention
Group E: Encorafenib - Cetuximab - mCRCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Trough concentration (Ctrough)

Trough concentration (Ctrough) shows the blood concentration reached by a drug immediately before the next dose is administered, once steady state has been attained. It can also be defined as the minimal drug concentration in the patient's body. Plasmatic measures will be performed by liquid chromatography with tandem mass spectrometry after protein precipitation by acetonitrile.

Time frame
From inclusion untill the end of treatment up to 4 years

Secondary outcomes

1

Progression-free survival

Progression-free survival (PFS) is the lenght of the time between inclusion and the first event of disease progression or death whatever the cause.

Time frame
4 years
2

Overall survival

Overall survival (OS) is the lenght of time between inclusion and death whatever the cause.

Time frame
4 years
3

Objective response rate

Objective response rate (ORR) is the percentage of patients with a best response during treatment being either complete response (CR) or partial response (PR).

Time frame
4 years
4

Disease control rate

Disease control rate (DCR) is defined as the percentage of patients with a best response during treatment being either CR, PR, or Stable Disease (SD).

Time frame
4 years

Other outcomes

Sponsors and contacts

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