Clinical trial NCT02607332 (phase 2, status: completed)
Conditions: gastrointestinal stromal tumors
ICD codes: C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9
Drugs: paclitaxel
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Age 20 years or older

          -  Histologically confirmed metastatic and/or advanced GIST with CD117(cluster of
             differentiation 117)(+), DOG-1(+), or mutation in KIT or PDGFRα gene(Platelet Derived
             Growth Factor Receptor)

          -  Failed (progressed and/or intolerable) after prior treatments for GIST, including at
             least both imatinib and sunitinib .

          -  Eastern Cooperative Oncology Group performance status of 0~2

          -  Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-Common
             Toxicity Criteria for Adverse Effects version 3.0

          -  At least one measurable lesion as defined by Response Evaluation Criteria In Solid
             Tumors version 1.0

          -  Adequate bone marrow, hepatic, renal, and other organ functions

               -  Neutrophil > 1,500/mm3

               -  Platelet > 100,000/mm3

               -  Hemoglobin > 8.0 g/dL

               -  Total bilirubin < 1.5 x upper limit of normal (ULN)

               -  Aspartate aminotransferase /Alanine transferase< 2.5 x ULN (or < 5 x ULM in case
                  of liver metastases)

               -  Creatinine < 1.5 x ULN

          -  Life expectancy > 12 weeks

          -  Washout period of previous TKIs(Tyrosine Kinase Inhibitor) or chemotherapy for more
             than 4 times the half life.

          -  Provision of a signed written informed consent

        Exclusion Criteria:

          -  Women of child-bearing potential who are pregnant or breast feeding or adults of
             reproductive potential not employing an effective method of birth control.

          -  have the presence of cardiac disease,including a myocardial infarction within 6 months
             prior to study entry,Clinically significant cardiac disease (New York Heart
             Association, Class III or IV) or severe unstable angina pectoris, stroke or transient
             ischemic attack, Arrhythmia in need of treatment

          -  Uncontrolled infection

          -  Diabetes mellitus (insulin dependent or independent disease, requiring chronic
             medication) with signs of clinically significant peripheral vascular disease.

          -  Acute and chronic liver disease and all chronic liver impairment.(Patients with stable
             and chronic viral hepatitis are eligible are acceptable)

          -  Uncontrolled gastrointestinal toxicities with toxicity greater than NCI Common
             Toxicity Criteria for Adverse Effects grade 2

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality.

          -  The patient experienced any bleeding episode considered life-threatening, or any grade
             3 or 4 bleeding event.

          -  Major surgery ≤ 28 days prior to starting study drug or who have not recovered from
             side effects of such therapy.

          -  Known diagnosis of HIV infection .

          -  History of another primary malignancy that is currently clinically significant or
             currently requires active intervention.

          -  Patients with brain metastases as assessed by radiologic imaging

          -  Alcohol or substance abuse disorder.