Solid Tumors Habouring NTRK Fusion
Conditions
Interventions
investigational material(s)
Generic name etc : Drug: BAY2757556 (Larotrectinib, Vitrakvi), Other Name: LOXO-101
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Adm
Sponsors
Bayer Yakuhin, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion identified through molecular assays - Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy - Subjects must have at least one measurable lesion as defined by RECIST v1.1
Exclusion criteria
Exclusion criteria: - Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. Subjects who received less than 28 days of treatment and discontinued because of intolerance or toxicity are eligible. - Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain metastases are eligible to participate in the study.) Subjects with primary CNS tumors are eligible. - Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures. - Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics Best Overall Response Rate by independent radiology committee (IRC) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory 1. Best overall response rate by investigator [ Time Frame: Up to 68 months ] Proportion of subjects with either complete response or partial response as determined by the treating investigator using RECIST or RANO criteria. 2. Duration of response (DOR) by IRC [ Time Frame: Up to 68 months ] Duration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death. Complete response, partial response and disease progression are assessed by an independent radiology committee (IRC). 3. Duration of response (DOR) by investigator [ Time Frame: Up to 68 months ] Duration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death. Complete response, partial response and disease progression are assessed by the treating investigator. 4. Clinical benefit rate (CBR) [ Time Frame: Up to 68 months ] Proportion of subjects with best overall response of complete response, partial response or stable disease lasting 16 or more weeks following the initiation of larotrectinib. 5. Progression-free survival (PFS) after Larotrectinib [ Time Frame: Up to 68 months ] Number of months from initiation of larotrectinib to either disease progression or death due to any cause. 6. Overall survival time [ Time Frame: Up to 68 months ] Number of months from the initiation of larotrectinib to the date of death due to any cause. 7. Progression-free survival (PFS) after past cancer therapy [ Time Frame: Up to 68 months ] Number of months from initiation of the line of therapy preceding larotrectinib to either disease progression or death due to any cause. 8. Number of subjects with adverse events [ Time Frame: Up to 68 months ] 9. Number of subjects with serious adverse events [ Time Frame: Up to 68 months ] 10. Number of subjects with treatment-related adverse events [ Time Frame: Up to 68 months ] 11. Severity of adverse events | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed