Clinical trial NCT01068769 (phase 2, status: completed)
Conditions: gastrointestinal stromal tumor
ICD codes: C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9
Drugs: regorafenib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age at the time of study entry

          -  Histologically confirmed metastatic and/or unresectable GIST with prior failure of
             both conventional tyrosine kinase inhibitors, imatinib and sunitinib.

          -  Measurable disease per RECIST 1.1. A lesion in a previously irradiated area is
             eligible to be considered as measurable disease as long as there is objective evidence
             of progression of the lesion.

          -  ECOG Performance Status 0 or 1

          -  Adequate organ and marrow function as outlined in the protocol

          -  Fully recovered from the acute effects of prior cancer therapy before initiation of
             study drug

          -  Patients must be suitable for oral drug administration

          -  Willingness to use effective means of birth control throughout the duration of
             clinical study and for at least 3 months after completion of study drug

          -  Women of childbearing potential must have a negative pregnancy test performed within 7
             days of the start of study drug administration

        Exclusion Criteria:

          -  Use of any unapproved tyrosine kinase inhibitors or investigational agents within 2
             weeks or 6 half-lives of the agent, whichever is shorter, prior to receiving study
             drug

          -  Participants who have had radiotherapy within 4 weeks prior to study entry

          -  Major surgery, or significant traumatic injury within 4 weeks prior to study entry

          -  Presence of symptomatic or uncontrolled brain or central nervous system metastases

          -  Prior exposure to sorafenib

          -  Prior exposure to regorafenib

          -  Known or suspected allergy to the investigational agent or any agent given in
             association with this trial

          -  Individuals with a history of a different malignancy, other than cervical cancer in
             situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if
             they have been disease-free for at least 5 years, and are deemed by the investigator
             to be at low risk for recurrence of that malignancy or other primary malignancy is
             neither currently clinically significant nor requiring active intervention

          -  Clinically significant cardiac arrhythmias and/or patients who require anti-arrhythmic
             therapy (excluding beta blockers or digoxin)

          -  History of clinically significant cardiac disease or congestive heart failure > NYHA
             class 2. Patients must not have unstable angina or new-onset angina within the last 3
             months or myocardial infarction within the past 6 months

          -  Hypertension as defined by systolic blood pressure 140-159 mmHg or diastolic blood
             pressure 90-99 mmHg; recurrent or persistent or symptomatic increase by > 20 mmHg
             (diastolic) or to systolic blood pressure greater than 140 mmHg or diastolic blood
             pressure greater than 90 mmHg if previously within normal limits, despite optimal
             medical management

          -  Arterial or venous thrombotic or embolic events such as cerebrovascular accident
             (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism
             within the 6 months before start of study medication

          -  Ongoing infection of Grade 3 or higher

          -  Patients with evidence of, or history of, bleeding diathesis. Any major hemorrhage or
             bleeding event of Grade 3 or higher within 4 weeks of start of study medication

          -  Non-healing wound, ulcer or bone fracture

          -  Renal failure requiring hemo-or peritoneal dialysis

          -  Dehydration of Grade 2 or greater

          -  Persistent proteinuria Grade 3 or higher

          -  Known history of HIV infection or chronic hepatitis B or C

          -  Uncontrolled intercurrent illness

          -  Pregnant or lactating females