Clinical trial NCT00726583 (phase 1, status: completed)
Conditions: advanced solid tumors
ICD codes: K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123
Drugs: px-866
SMILES: COC[C@H]1OC(=O)\C(=C\N(CC=C)CC=C)C2=C(O)C(=O)C3=C([C@@H](C[C@@]4(C)[C@H]3CCC4=O)OC(C)=O)[C@@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of advanced solid tumor and has
             failed or is intolerant of standard therapy, or for whom standard therapy does not
             exist.

          -  18 years of age or older.

          -  ECOG performance status 0 to 1.

          -  Predicted life expectancy of at least 12 weeks.

          -  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 the
             prior treatment (recovered to baseline or ≤grade 1 per Common Toxicity Criteria for
             Adverse Events (CTCAE)).

          -  Discontinued any radiation therapy for at least four weeks and have recovered from all
             radiation-related toxicities (recovered to baseline or ≤CTCAE grade 1) prior to
             receiving the first dose of study drug. Palliative radiation of 10 fractions or less
             is permitted and a four week interval is not necessary (also allowed during therapy).

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

          -  Adequate hepatic function as defined by the following: 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.

          -  Adequate renal function as defined by serum creatinine level <1.5 mg/dL.

        Exclusion Criteria:

          -  Any active infection at study entry.

          -  Known diabetes or fasting blood glucose>160 mg/dL.

          -  Known human immunodeficiency virus (HIV).

          -  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

          -  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 or for
             which the patient requires treatment with steroids or anticonvulsants. In the case of
             previously treated brain metastases, a minimum four week 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.

          -  Leptomeningeal brain metastases should be excluded regardless of whether the
             metastases have been treated or not.

          -  History of seizures, non-healing wounds, or arterial thrombosis.

          -  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.

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

          -  Total gastrectomy, partial bowel obstruction or any gastrointestinal condition that
             may interfere with absorption of the study medication.

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