Clinical trial NCT00658970 (phase 1, status: completed)
Conditions: solid tumors, lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: kx2-391
SMILES: O=C(CC1=CC=C(C=N1)C1=CC=C(OCCN2CCOCC2)C=C1)NCC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent

          -  Adults over age 18 years of age

          -  Confirmed advanced solid tumor or lymphoma that may be metastatic or unresectable and
             for which standard curative or palliative measures do not exist or are no longer
             effective; patients with treated brain or ocular metastases are also eligible

          -  ECOG performance status of 0-2

          -  Life expectancy of at least 14 weeks

          -  Adequate bone marrow reserve

          -  Adequate liver function as demonstrated by serum bilirubin, alanine aminotransferase
             (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP)

          -  Adequate renal function (serum creatinine </= 1.5 x ULN or calculated creatinine
             clearance > 60 ml/min)

          -  Normal coagulation profile (PT/INR and aPTT within institutional normal limits) for
             those who give consent to tumor biopsy, within 1 week prior to the procedure.

          -  Negative pregnancy test for females at Screening, preferably done within 1 week before
             Day 1 of dosing (not applicable to patients with bilateral oophorectomy and/or
             hysterectomy)

          -  Willing to abstain from sexual activity or practice physical barrier contraception 28
             days before Day 1 of dosing and 6 months after the last dose for the patient

          -  Signed written informed consent for tumor biopsy for the additional 10 subjects that
             will be dosed at the MTD and who have accessible tumors

        Exclusion Criteria:

          -  Unresolved toxicity of higher than Grade 1 severity from previous anti-cancer
             treatment or investigational agents

          -  Receiving or having received investigational agents or systemic anti-cancer agents
             within 14 days of Day 1 of dosing or 28 days for those agents with unknown elimination
             half-lives or half-lives of greater than 50 hours

          -  Received extensive radiation therapy including sternum, pelvis, scapulae, vertebrae or
             skull, </= 4 weeks or low dose palliative radiation therapy limited to limbs </= 1
             week prior to starting study drug, or who have not recovered from side effects of such
             therapy

          -  Currently taking hormones (i.e., estrogen contraceptives, hormone replacement,
             anti-estrogen), anti-platelet agents or anti-coagulants, e.g. coumadin, except for
             those who are on prophylactic doses of anti-coagulants for indwelling venous catheters

          -  Use of strong inhibitors or inducers of cytochrome P450 3A4 enzymes 2 weeks or 5
             half-lives prior to Day 1 of dosing and during the study (refer to Appendix 3)

          -  Pregnant or breast-feeding

          -  Major surgery within 4 weeks prior to Day 1 of dosing

          -  Major surgery to the upper gastrointestinal tract, or inflammatory bowel disease,
             malabsorption syndrome or other medical condition that may interfere with oral
             absorption

          -  Signs or symptoms of end organ failure, major chronic illnesses other than cancer, or
             any severe concomitant conditions which, in the opinion of the investigator, makes it
             undesirable for the subject to participate in the study or which could jeopardize
             compliance with the protocol

          -  History of angina pectoris, coronary artery disease or cerebrovascular accident,
             transient ischemic attack or cardiac arrhythmia requiring medical therapy

          -  Evidence of hepatitis B or C, human immunodeficiency (HIV) infection, coagulation
             disorders, or hemolytic conditions, e.g. sickle cell anemia