Clinical trial NCT02138526 (phase 1, status: completed)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: pazopanib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must provide written informed consent prior to performance of study-specific
             procedures or assessments and must be willing to comply with treatment and follow-up.

             Note: informed consent may be obtained prior to start of the specified screening
             window.

             Note: procedures conducted as part of the subject's routine clinical management (e.g.
             blood count) and obtained prior to signing of informed consent may be utilized for
             screening or baseline purposes provided these procedures are conducted as specified in
             the protocol.

          2. ≥ 18 year old men and women who use pazopanib

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          4. Adequate organ system function

        Exclusion Criteria:

          1. Poorly controlled hypertension; systolic blood pressure (SBP) ≥ 40 mm Hg or diastolic
             blood pressure (DBP) ≥ 90 mm Hg.

             Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to
             study entry. Following antihypertensive medication initiation or adjustment, blood
             pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At
             least 24 hours must have elapsed between anti-hypertensive medication initiation or
             adjustment and BP measurement. These three values should be averaged to obtain the
             mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP
             ratio must be <140/90 mmHg (OR 150/90 mm Hg, if this criterion is approved by Safety
             Review Team) in order for a subject to be eligible for the study.

          2. Corrected QT interval (QTc) > 480msecs.

          3. History of any one or more of the following cardiovascular conditions within the past
             6 months:

               -  Cardiac angioplasty or stenting

               -  Myocardial infarction

               -  Unstable angina

               -  Coronary artery bypass graft surgery

               -  Symptomatic peripheral vascular disease

               -  Class III or IV congestive heart failure, as defined by the New York Heart
                  Association (NYHA)

          4. Clinically significant gastrointestinal abnormalities that may increase the risk for
             gastrointestinal bleeding including, but not limited to:

               -  Active peptic ulcer disease

               -  Known intraluminal metastatic lesion/s with risk of bleeding

               -  Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other
                  gastrointestinal conditions with increased risk of perforation.

               -  History of abdominal fistula, gastrointestinal perforation, or intra abdominal
                  abscess within 28 days prior to beginning study treatment.

          5. Clinically significant gastrointestinal abnormalities that may affect absorption of
             investigational product including, but not limited to:

               -  Malabsorption syndrome.

               -  Major resection of the stomach or small bowel.

          6. History of cerebrovascular accident including transient ischemic attack (TIA),
             pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.

             Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating
             agents for at least 6 weeks are eligible.

          7. Major surgery or trauma within 28 days prior to first dose of investigational product
             and/or presence of any non-healing wound, fracture, or ulcer (procedures such as
             catheter placement not considered to be major surgery).

          8. Evidence of active bleeding or bleeding diathesis.

          9. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that
             increase the risk of pulmonary hemorrhage.

             Note: Lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are
             excluded; however, the presence of a tumor that is touching, but not infiltrating
             (abutting) the vessel is acceptable (CT with contrast is strongly recommended to
             evaluate such lesions).

         10. Recent hemoptysis (½ teaspoon of red blood within 8 weeks before first dose of study
             drug).

         11. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that
             could interfere with subject's safety, provision of informed consent, or compliance to
             study procedures.

         12. Unable or unwilling to discontinue use of prohibited medications for at least 14 days
             or five half-lives of a drug (whichever is longer) prior to the first dose of day 1
             and for the duration of the study.

         13. Concurrent use of other substances known or likely to interfere with the
             pharmacokinetics of pazopanib.

             Patients, who are adjusted to proton pump inhibitors and had no dose modifications for
             over two weeks, are allowed to participate

         14. Women of childbearing potential without adequate contraception, pregnant or
             breastfeeding women.