check_circleStudy Completed
Solid tumors harboring NTRK fusion
Bayer Identifier:
20288
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study to test the safety of the investigational drug larotrectinib in adults that may treat cancer
Trial purpose
This research study is done to test the safety of the drug larotrectinib in adult cancer patients. The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells. The study also investigates how the drug is absorbed and processed in the human body. This is the first study to test larotrectinib in humans with cancer, for whom no other effective therapy exists.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
75Trial Dates
May 2014 - April 2021Phase
Phase 1Could I Receive a placebo
NoProducts
Vitrakvi (Larotrectinib, BAY2757556)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Massachusetts General Hospital | Boston, 02114, United States |
Completed | University of Pennsylvania | Philadelphia, 19104, United States |
Completed | Sarah Cannon Research Institute | Nashville, 37203, United States |
Completed | University of Colorado | Aurora, 80045, United States |
Completed | University Hospitals Cleveland Medical Center | Cleveland, 44106, United States |
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Completed | Oregon Health and Science University | Portland, 97239, United States |
Completed | University of Pittsburgh | Pittsburgh, 15232, United States |
Primary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:25 months
- Severity of adverse eventsThe severity of adverse events will be assesssed according to the NCI CTCAE version 4.03.date_rangeTime Frame:25 months
- Maximum tolerated dose (MTD)date_rangeTime Frame:25 months
- Recommended dose for dose expansiondate_rangeTime Frame:25 months
Secondary Outcome
- Maximum concentration of larotrectinib in plasma (Cmax)date_rangeTime Frame:Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1
- Time to maximum concentration of larotrectinib in plasma (Tmax)date_rangeTime Frame:Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1
- Half-life of larotrectinib in plasma (t1/2)date_rangeTime Frame:Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1
- Area under the concentration versus time curve of larotrectinib in plasma (AUC)date_rangeTime Frame:Predose and 0.25, 0.5, 1, 2, 4, 6 and 8 hours after drug administration on Days 1 and 8 of Cycle 1
- Overall Response Rate (ORR)Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriatedate_rangeTime Frame:Up to 60 months
- Duration of Response (DOR)date_rangeTime Frame:Up to 60 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
7