A Registry study of Larotrectinib chemotherapy in patients with NTRK fusion positive recurrent salivary gland cancer as second-line treatment

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0007143

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 5

Inclusion Criteria

1) This study is intended for adult patients over the age of 19 who are scheduled to receive larotrectinib (Vitrakvi®) as a second-line treatment for metastatic salivary gland cancer with NTRK fusion confirmed through pan-TRK IHC test. In the definition of primary treatment, only chemotherapy and simultaneous chemotherapy are accepted, and radiation therapy and surgery are excluded.
2)A patient who has been informed of all explanations before participating in the clinical trial, has signed the consent form, and understands that there is no disadvantage in withdrawing consent
3) Patients 19 years of age or older who have signed a consent form for clinical trials
4) ECOG performance status 0, 1
5 )One or more measurable lesions according to RECIST v1.1. A lesion that has progressed after radiation therapy can also become a target lesion.
6)Women of childbearing potential should have a negative urine or serum pregnancy test within 72 hours of administration of the test drug. If the urine test is positive, a serum pregnancy test should be performed to confirm that it is negative.
7) Patients with adequate organ function. Screening blood tests must be performed within 14 days of starting treatment
Hematological
Absolute neutrophil count (ANC)=1,500 /mcL
Platelets=100,000 / mcL
Hemoglobin=9 g/dL or =5.6 mmol/L

Renal
Serum creatinine =1.5 X upper limit of normal (ULN)
OR
Measured or calculateda creatinine clearance =60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
(GFR can also be used in place of creatinine or CrCl)

Hepatic
Serum total bilirubin= 1.5 X ULN
AST (SGOT) and ALT (SGPT)= 3.0 X ULN (with or without liver metastases)

Coagulation
International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5 X ULN unless subject is receiving anticoagulant therapy
as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Activated Partial Thromboplastin Time (aPTT)=1.5 X ULN unless subject is receiving anticoagulant therapy
as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Exclusion Criteria

1) Patients with known hypersensitivity to the active ingredient or excipients of larotrectinib (Vitrakvi®)
2) Patients who participated in other clinical trials within 4 weeks of administration of the study drug in this study and used the test drug or test equipment.
3) Patients who have received chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks before administration of the study drug, or whose side effects from previous treatment have not recovered to baseline or grade 1 or lower
4) Patients with an ongoing malignancy other than salivary gland cancer within 5 years or other malignancy requiring aggressive treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and treated cervical cancer in situ can be registered.
5) Patients with severe active infection requiring systemic treatment.
6) Patients with uncontrolled epilepsy, central nervous system disorders, or psychotic disorders, who have difficulties understanding the study consent process or who are considered to interfere with adherence to study drug administration.
7) Patients who are pregnant, breastfeeding, or expected from screening to 120 days after the last dose of study drug