Trial Condition(s):
Solid tumors harboring NTRK fusion
A study to test the effect of the drug larotrectinib in adults and children with NTRK-fusion positive solid tumors (NAVIGATE)
Bayer Identifier:
20289
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.
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 v1.1Exclusion 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.Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Institut Bergonié - Unicancer Nouvelle Aquitaine BORDEAUX CEDEX, France, 33076 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Finsen Centre Copenhagen, Denmark, 2100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Hospital East Kashiwa, Japan, 277-8577 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UCLA-Santa Monica Medical Center Santa Monica, United States, 90404 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Massachusetts General Hospital Boston, United States, 02114 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vanderbilt University Medical Center Nashville, United States, 37232 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Sloan Kettering Cancer Center New York, United States, 10038 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inova Health Care Services Falls Church, United States, 22042 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fox Chase Cancer Center Philadelphia, United States, 19111 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Thomas Jefferson University Philadelphia, United States, 19107 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cleveland Clinic Cleveland, United States, 44195-0002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of North Carolina Hospitals Chapel Hill, United States, 27599 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Virginia University Morgantown, United States, 26506 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27157-1082 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Hospital West Pembroke, United States, 33028 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Avera Cancer Institute Sioux Falls, United States, 57105 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dana-Farber Cancer Institute Boston, United States, 02215 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Washington Seattle, United States, 98109 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institute Of Cancer-Barts and The London School of Medicine London, United Kingdom, EC1M 6BQ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southampton General Hospital Southampton, United Kingdom, SO16 6YD | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University College Hospital London, United Kingdom, W1T 7HA | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Chicago Chicago, United States, 60637 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Vincent's University Hospital Dublin, Ireland, D04 T6F4 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stanford Cancer Center Palo Alto, United States, 94304 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongshan Hospital, Fudan University Shanghai, China, 200032 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sichuan University West China Hospital Chengdu, China | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Cancer Hospital Beijing, China, 100142 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Comprehensive Cancer Center (CCCC) Berlin, Germany, 10115 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Integral Oncológico Clara Campal Madrid, Spain, 28050 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacion Jimenez Diaz (Clinica de la Concepcion) Madrid, Spain, 28040 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IPO Porto Porto, Portugal, 4200-072 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Singapore, Singapore, 169610 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hackensack University Medical Center Hackensack, United States, 07601 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Cancer Institute Hospital of JFCR Koto-ku, Japan, 135-8550 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario "Marqués de Valdecilla" Santander, Spain, 39008 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Miskolc, Hungary, 3526 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tri-Service General Hospital Taipei, Taiwan, China | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal North Shore Hospital St Leonards, Australia, 2065 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A phase 2 basket study of the oral TRK inhibitor larotrectinib in subjects with NTRK fusion-positive tumors
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
12
Primary Outcome
- Best overall response rate by IRCProportion of subjects with either complete response or partial response as determined by an independent radiology committee (IRC) using RECIST or RANO criteria.Timeframe: Up to 120 months
Secondary Outcome
- Best overall response rate by investigatorProportion of subjects with either complete response or partial response as determined by the treating investigator using RECIST or RANO criteria.Timeframe: Up to 120 months
- Duration of response (DOR) by IRCDuration 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).Timeframe: Up to 120 months
- Duration of response (DOR) by investigatorDuration 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.Timeframe: Up to 120 months
- Clinical benefit rate (CBR)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.Timeframe: Up to 120 months
- Progression-free survival (PFS) after LarotrectinibNumber of months from initiation of larotrectinib to either disease progression or death due to any cause.Timeframe: Up to 120 months
- Overall survival timeNumber of months from the initiation of larotrectinib to the date of death due to any cause.Timeframe: Up to 120 months
- Progression-free survival (PFS) after past cancer therapyNumber of months from initiation of the line of therapy preceding larotrectinib to either disease progression or death due to any cause.Timeframe: Up to 120 months
- Number of subjects with adverse eventsTimeframe: Up to 120 months
- Number of subjects with serious adverse eventsTimeframe: Up to 120 months
- Number of subjects with treatment-related adverse eventsTimeframe: Up to 120 months
- Severity of adverse eventsTimeframe: Up to 120 months
- Severity of serious adverse eventsTimeframe: Up to 120 months
- Severity of treatment-related adverse eventsTimeframe: Up to 120 months
- Duration of adverse eventsTimeframe: Up to 120 months
- Duration of serious adverse eventsTimeframe: Up to 120 months
- Duration of treatment-related adverse eventsTimeframe: Up to 120 months
- Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administrationTimeframe: Up to 120 months
- Severity of safety-relevant changes in clinical parameters or vital signs after drug administrationTimeframe: Up to 120 months
- Proportion of subjects that has any tumor regression as a best responseTimeframe: Up to 120 months
- Concordance coefficientDescribes the concordance of prior molecular profiling that detected an NTRK fusion within the subject’s tumor and a diagnostic test being evaluated by the sponsor.Timeframe: Up to 120 months
Additional Information
Not Available
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