- To be considered eligible to participate in this study, all of the following
requirements must be met:
1. Patients in Phase 1 must have metastatic or locally advanced solid tumors who
have failed to respond to standard therapy
2. All patients must have confirmation of either ALK positive or TRK positive
3. Patients in Phase 1 will not be required to have measurable disease. All
patients in Phase 2a will be required to have measurable disease by RECIST.
4. All patients enrolled in this study must have tumor tissue available.
5. Patient (male or female) must be 18 years of age (except where age of majority
is 16 years in a particular country, such as the United Kingdom).
6. Patient must have performance status 2 on the ECOG Performance Scale.
7. Patient must have an estimated life expectancy of at least 3 months.
8. Patients must have adequate organ function.
9. For patients previously treated with myelosuppressive therapy, at least 3 weeks
must have elapsed and toxicity must have recovered to grade 1 or baseline.
Non-myelosuppressive therapy patients must have recovered from all
treatment-related toxicities. Fourteen days must have elapsed since palliative
radiation for bone metastasis.
10. Female patients of childbearing potential must have a negative serum pregnancy
test and use adequate birth control for the duration of study participation and
for 3 months after the last dose of study drug.
11. The patient or his or her legal representative must be able to read, understand,
and provide signed informed consent.
12. Patient is able to understand the study procedures and agrees to participate in
the study by giving written informed consent.
- Patients will not be deemed eligible for entry into this study if any of the
following criteria are met:
1. Patient has leukemia.
2. Patient is a pregnant or lactating female.
3. Patient has uncontrolled congestive heart failure, angina, or has had a
myocardial infarction in the preceding 3 months.
4. Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2, atrial fibrillation of any
grade, or QTc interval >450 msec.
5. Patients with risk factors for Torsade de point and patients receiving
concomitant medication with QT-prolonging medicines.
6. Patient has an uncontrolled concurrent medical condition or disease.
7. Patient has undergone bone marrow or stem cell transplantation in the past 6
8. Patient has a known hypersensitivity to the components of TSR-011 or the
9. Patient has active or uncontrolled infection.
10. Patient has a known psychiatric or substance abuse disorder.
11. Patient has active second primary malignancy.
12. Patient is observed to have a clinically active central nervous system (CNS)
metastases or carcinomatous meningitis.
13. Patient has any other severe concurrent disease which, in the judgment of the
Investigator, would preclude study participation.
14. Patient is known to be HIV positive or who has an AIDS-related illness.
15. Patient has a known history of or active (treated or not) Hepatitis B or C.
16. Patient has presence of ascites causing significant symptoms.
17. A patient must stop taking any prescription, over-the-counter, or herbal remedy
known to be an inhibitor or inducer of CYP3A4/5.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both