Clinical trial NCT00078637 (phase 1, status: completed)
Conditions: neoplasms, lymphoma, malignant
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: e7820
SMILES: CC1=C2C(=CNC2=C(NS(=O)(=O)C2=CC=CC(=C2)C#N)C=C1)C#N
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histologically or cytologically confirmed malignant solid tumor
             or lymphoma. Malignancy must be advanced and require systemic therapy. Malignancy must
             be one for which no standard therapy is available or the patient must not be a
             candidate for standard therapy.

          -  Patients must have a Karnofsky Performance Status of >= 70%,

          -  Patients must have a life expectancy of >= 3 months,

          -  Patients must be aged >= 18 years,

          -  Patients must have adequate renal function as evidenced by serum creatinine <= 1.5
             mg/dL or creatinine clearance >= 60 mL/minute/1.73m2,

          -  Patients must have adequate bone marrow function as evidenced by ANC >= 1,500 mm3 and
             platelets >= 100,000 mm3, must have adequate liver function as evidenced by bilirubin
             <= 1.5 mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2.5
             times the upper limits of normal (ULN) (unless related to liver metastases in which
             case <= 5 x ULN),

          -  Patients must be willing and able to comply with the study protocol for the duration
             of the study, and

          -  Patients must give written informed consent prior to any study-specific screening
             procedures with the understanding that the patient may withdraw consent at any time
             without prejudice.

        Exclusion Criteria:

          -  Patients who have a history of previous hypersensitivity to sulfonamide derivatives,
             Patients who have received chemotherapy within 4 weeks (6 weeks if nitrosoureas were
             received) of commencing study treatment,

          -  Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic
             radiation) within 4 weeks of E7820 treatment,

          -  Patients who have not recovered from any clinically significant chemotherapy or
             radiotherapy related toxicity at study entry.

          -  Patients who have received investigational drugs or other antineoplastic therapy
             within 28 days of E7820 treatment,

          -  Patients who have had major surgery within 4 weeks of study drug administration,

          -  Women who are pregnant or breast-feeding. -- Women of childbearing potential with
             either a positive pregnancy test at screening or no pregnancy test. Women of
             childbearing potential unless (1) surgically sterile or (2) using adequate measures of
             contraception in the opinion of the Investigator (postmenopausal women must be
             amenorrheic for at least 12 months to be considered of non-childbearing potential),

          -  Fertile men and fertile women who are not willing to use contraception or fertile men
             or fertile women with a partner who is not willing to use contraception,

          -  Patients with active central nervous system (CNS) metastases (i.e., evidence of
             progressive clinical symptoms, edema requiring corticosteroids, or tumors exhibiting
             growth on sequential MRI or CT scans),

          -  Patients who are known to be positive for hepatitis B surface antigen, hepatitis B
             core antibody, hepatitis C antibody, or human immunodeficiency virus,

          -  Patients with severe uncontrolled intercurrent illness/infection (excluding
             malignancies),

          -  Patients with a history of unstable ischemic disease,

          -  Patients with a history of clinically significant thrombosis,

          -  Patients receiving antithrombotic (including aspirin) or therapeutic anticoagulant
             therapy (prior to study entry, patients receiving these types of drugs must have been
             off therapy for at least 7 days),

          -  Patients with a history of documented vascular headache with neurological changes,

          -  Patients < 30% of ideal weight for height and age according to the Metropolitan Life
             Insurance Company Statistical Bulletin, or

          -  Patients with significant disease, or any condition, which in the Investigator's
             opinion would exclude the patient from the study, or

          -  Patients who have pulmonary disease that puts them at risk of hemoptysis.