Trial Condition(s):
Solid tumors harboring NTRK fusion
A study to test the safety of the investigational drug larotrectinib in adults that may treat cancer
Bayer Identifier:
20288
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists.
- Proof of a malignancy harboring a NTRK fusion
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 and a life expectancy of at least 3 months
- Adequate hematologic, hepatic, and renal functionExclusion Criteria
- Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible
- Clinically significant active cardiovascular disease or history of myocardial infarction
- Active uncontrolled systemic bacterial, viral, or fungal infection
- Current treatment with a strong CYP3A4 inhibitor or inducer
- Pregnancy or lactationTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Massachusetts General Hospital Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pennsylvania Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sarah Cannon Research Institute Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Colorado Aurora, United States, 80045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospitals Cleveland Medical Center Cleveland, United States, 44106-2602 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oregon Health and Science University Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pittsburgh Pittsburgh, United States, 15232 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A phase 1 study of the oral TRK inhibitor larotrectinib in adult patients with solid tumors
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Sequential Assignment
Trial Arms:
7
Primary Outcome
- Number of participants with adverse eventsTimeframe: 25 months
- Severity of adverse eventsThe severity of adverse events will be assesssed according to the NCI CTCAE version 4.03.Timeframe: 25 months
- Maximum tolerated dose (MTD)Timeframe: 25 months
- Recommended dose for dose expansionTimeframe: 25 months
Secondary Outcome
- Maximum concentration of larotrectinib in plasma (Cmax)Timeframe: 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)Timeframe: 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)Timeframe: 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)Timeframe: 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 appropriateTimeframe: Up to 60 months
- Duration of Response (DOR)Timeframe: Up to 60 months
Additional Information
Not Available
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