Clinical trial NCT00550927 (phase 1, status: completed)
Conditions: unspecified adult solid tumor, protocol specific
ICD codes: H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: enzastaurin hydrochloride
SMILES: CN1C=C(C2=CC=CC=C12)C1=C(C(=O)NC1=O)C1=CN(C2CCN(CC3=CC=CC=N3)CC2)C2=CC=CC=C12
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologic or cytologic diagnosis of locally advanced or metastatic cancer for which
             no preferable therapy exists

          -  Measurable or nonmeasurable disease

          -  No CNS metastases or a primary CNS tumor

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  WBC count ≥ 3.0 × 10^9/L

          -  Absolute neutrophil count ≥ 1.5 × 10^9/L

          -  Platelet count ≥ 100 × 10^9/L

          -  Hemoglobin ≥ 10 g/dL (6.21 mmol/L)

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)

          -  AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)

          -  Serum creatinine < 1.5 times ULN

          -  No proteinuria at baseline, as demonstrated by either of the following:

               -  Urine protein:creatinine ratio < 1.0 at screening

               -  Urine dipstick for proteinuria < 2+ (patients discovered to have ≥ 2+ proteinuria
                  on dipstick urinalysis at baseline must undergo a 24-hour urine collection that
                  demonstrates ≤ 1 g of protein in 24 hours to be eligible for study participation)

          -  No second primary malignancy that could affect compliance with the study or
             interpretation of the study results

          -  No concurrent serious systemic disorder (e.g., active infection, including HIV) that,
             in the opinion of the investigator, would compromise the patient's ability to adhere
             to the study

          -  No known hypersensitivity to bevacizumab or enzastaurin hydrochloride, or to a
             component of either drug

          -  No prior bevacizumab-related toxicity requiring discontinuation, such as a
             thromboembolic event, hemorrhage, or serious hypertension

          -  No clinically significant cardiac disease, in the opinion of the investigator,
             including any of the following:

               -  Myocardial infarction within the past 6 months

               -  Symptomatic angina pectoris

               -  Congestive heart failure not controlled by medications

               -  ECG abnormalities indicative of clinically significant cardiac disease

          -  No evidence of bleeding diathesis or coagulopathy

          -  No nonhealing cutaneous wound or gastrointestinal ulcer

          -  No history of or risk for abdominal fistula, gastrointestinal perforation, or
             intra-abdominal abscess within the past 6 months

          -  No hemoptysis requiring medical attention within the past 3 months

          -  No known history of cerebrovascular accidents or transient ischemic attacks

          -  No clinically significant vascular or peripheral vascular disease

          -  No hypertension not controlled by medical management

          -  No history of hypertensive crisis or hypertensive encephalopathy

          -  No significant traumatic injury within the past 28 days

          -  Able to comply with study or study procedures

          -  Able to swallow tablets

          -  Exhibits compliance and geographic proximity that allow adequate follow-up

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

          -  No prior participation in this study or any other study involving enzastaurin
             hydrochloride

          -  At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)

          -  At least 4 weeks since prior radiotherapy, anticancer hormone therapy, or other
             investigational therapy

               -  Patients with hormone-refractory prostate cancer receiving luteinizing
                  hormone-releasing hormone analogue therapy (leuprolide or goserelin) prior to
                  study enrollment should continue therapy during study participation

          -  At least 6 weeks since prior bicalutamide

          -  At least 4 weeks since prior flutamide or nilutamide

          -  More than 10 days since prior and no concurrent aspirin > 325 mg/day

          -  More than 28 days since prior major surgery or open biopsy

          -  More than 7 days since prior core biopsy or other minor surgical procedure, excluding
             placement of a vascular access device

          -  No concurrent carbamazepine, phenobarbital, or phenytoin

          -  No concurrent systemic anticoagulation

          -  No concurrent chronic use of other nonsteroidal anti-inflammatory drugs

          -  No concurrent routine use of colony-stimulating factors

          -  No concurrent major surgery

          -  No other concurrent chemotherapy, radiotherapy, immunotherapy, or experimental
             medications

          -  No other concurrent antitumor therapy