Clinical trial NCT00522652 (phase 1, status: completed)
Conditions: advanced solid tumors, lymphoma
ICD codes: K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: px-478
SMILES: Cl.Cl.N[C@@H](CC1=CC=C(C=C1)[N+]([O-])(CCCl)CCCl)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  The patient has signed the informed consent and must be considered legally capable of
             providing his or her own consent for participation in this study.

          -  The patient has a histologically or cytologically confirmed diagnosis of advanced
             solid tumor or lymphoma and has failed or is intolerant of standard therapy.

          -  The patient is ≥18 years of age.

          -  ECOG performance status 0 to 1.

          -  The patient has a predicted life expectancy of at least 12 weeks.

          -  Patients must have discontinued prior chemotherapy or other investigational agents for
             at least three weeks prior to receiving the first dose of study drug (six weeks for
             mitomycin C, nitrosureas, vaccines, or antibody therapy) and recovered from the toxic
             effects of that treatment (recovered to baseline or ≤Common Toxicity Criteria for
             Adverse Events (CTCAE) grade 1).

          -  Patients must have discontinued any radiation therapy at least four weeks prior to
             entry into the study and have recovered from all radiation-related toxicities
             (recovered to baseline or ≤CTCAE grade 1).

          -  The patient has adequate hematologic function defined as: WBC count >3,000 cells/μL;
             platelets >100,000/μL; hemoglobin >9 g/dL (may be transfused to this level); ANC >1500
             cells/μL.

          -  The patient has adequate hepatic function defined as: bilirubin <1.5 mg/dL; aspartate
             aminotransaminase (AST/SGOT) & alanine aminotransferase (ALT/SGPT) <2.5 x ULN or <5 x
             ULN if due to metastatic disease.

          -  The patient has adequate renal function as defined by serum creatinine level <1.5
             mg/dL.

          -  Women of childbearing potential must agree to use adequate contraception (hormonal or
             barrier method; abstinence) prior to study entry and for the duration of study
             participation. The patient, if a man, agrees to use effective contraception or
             abstinence.

        Exclusion Criteria:

          -  Patients with any active infection requiring i.v. antibiotics at study entry.

          -  Any serious concomitant systemic disorders that in the opinion of the investigator
             would place the patient at excessive or unacceptable risk of toxicity.

          -  Surgery within the four weeks prior to the first dose of PX 478.

          -  Significant central nervous system (CNS) or psychiatric disorder(s) that preclude the
             ability of the patient to provide informed consent.

          -  Known or suspected brain metastases that have not received adequate therapy. In the
             case of previously treated brain metastases, a minimum of four weeks interval between
             completion of radiation therapy and registration on study with radiologic evidence of
             stable or responding brain metastases is required. In the setting of previous CNS
             metastasectomy, adequate (minimum four week) recovery from surgery and/or radiation
             therapy should be documented.

          -  Patients with a history of seizures, non-healing wounds, or arterial thrombosis.

          -  Patients with unstable atrial or ventricular arrhythmias requiring control by
             medication; any cardiac ischemic event experienced within the preceding six months;
             prior history of congestive heart failure requiring therapy.

          -  Patients who are breastfeeding or pregnant (confirmed by serum β-HCG within 10 days
             prior to the start of study treatment if applicable).

          -  Patients with total gastrectomy or partial bowel obstruction.

          -  Any condition that could jeopardize the safety of the patient and compliance with the
             protocol.