Clinical trial NCT00514306 (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: osi-906
SMILES: C[C@@]1(O)C[C@@H](C1)C1=NC(=C2N1C=CN=C2N)C1=CC=C2C=CC(=NC2=C1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented malignancy that is now advanced and/or
             metastatic and refractory to established forms of therapy or for which no effective
             therapy exists

          -  Patients with Eastern Cooperative Oncology Group (ECOG) performance status </= 2

          -  Predicted life expectancy ≥ 12 weeks

          -  Patients may have had prior therapy, providing the following conditions are met:

               -  Chemotherapy: A minimum of 3 weeks (4 weeks for carboplatin or investigational
                  anticancer agents and 6 weeks for nitrosoureas and mitomycin C) must have elapsed
                  between the end of treatment and registration into this study. Prior tyrosine
                  kinase inhibitor therapy is permitted. Patients must have recovered from any
                  treatment-related toxicities (except for alopecia, fatigue, and grade 1
                  neurotoxicity) prior to registration

               -  Hormonal therapy: Patients may have had prior anticancer hormonal therapy
                  provided it is discontinued prior to registration into this study. However,
                  patients with prostate cancer with evidence of progressive disease may continue
                  on therapy that produces medical castration (eg, goserelin or leuprorelin),
                  provided this therapy was commenced at least 3 months earlier

               -  Radiation: Patients may have had prior radiation therapy provided they have
                  recovered from the acute, toxic effects of radiotherapy prior to registration. A
                  minimum of 21 days must have elapsed between the end of radiotherapy and
                  registration into the study unless the radiotherapy was palliative and
                  nonmyelosuppressive

               -  Surgery: Previous surgery is permitted provided that wound healing has occurred
                  prior to registration

          -  Fasting glucose ≤ 125 mg/dL (7 mmol/L) at baseline

          -  Potassium, calcium, and magnesium must be within normal limits (WNL). Electrolyte
             abnormalities will be permitted if they are not clinically significant and if
             treatment for the abnormality is initiated prior to Day 1

          -  Adequate hematopoietic, hepatic, and renal function defined as follows:

               -  Neutrophil count ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L

               -  Bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN if patient has Gilbert's disease

               -  AST and/or ALT ≤ 2.5 x ULN or ≤ 5 x UNL if patient has documented liver
                  metastases

               -  Serum creatinine ≤ 1.5 x ULN

          -  Patients must be accessible for repeat dosing and follow-up, including pharmacokinetic
             sampling

          -  Patients - both males and females - with reproductive potential (ie, menopausal for
             less than 1 year and not surgically sterilized) must practice effective contraceptive
             measures (ie, barrier methods, eg, condom or diaphragm, with spermicide) throughout
             the study. Women of childbearing potential must provide a negative pregnancy test
             (serum or urine) within 14 days prior to registration

          -  Patients must provide written informed consent to participate in the study

        Exclusion Criteria:

          -  Documented history of diabetes mellitus

          -  History of significant cardiac disease unless the disease is well-controlled.
             Significant cardiac diseases includes second/third degree heart block; significant
             ischemic heart disease; QTc interval > 450 msec at baseline; poorly controlled
             hypertension; congestive heart failure of New York Heart Association (NYHA)Class II or
             worse (slight limitation of physical activity; comfortable at rest, but ordinary
             physical activity results in fatigue, palpitation, or dyspnea)

          -  Any type of active seizure disorder

          -  Concurrent anticancer therapy (with the exception of hormonal therapy as described
             above)

          -  Use of drugs with a risk of causing QT interval prolongation within 14 days prior to
             Day 1 and while on study

          -  Use of glucocorticoids within 14 days prior to Day 1 dosing and while on study, with
             the exception of hormone replacement therapy or inhalers

          -  History of any kind of stroke

          -  Previously diagnosed brain metastases (includes active brain metastases)

          -  Active or uncontrolled infections or serious illnesses or medical conditions that
             could interfere with the patient's ongoing participation in the study

          -  History of any psychiatric condition that might impair the patient's ability to
             understand or to comply with the requirements of the study or to provide informed
             consent

          -  Pregnant or breast-feeding females

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to the study drug