Clinical trial NCT00379080 (phase 1/phase 2, status: completed)
Conditions: adult brain tumor, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: tandutinib
SMILES: COC1=C(OCCCN2CCCCC2)C=C2N=CN=C(N3CCN(CC3)C(=O)NC3=CC=C(OC(C)C)C=C3)C2=C1
Eligibility criteria:

        Criteria:

          -  Histologically confirmed glioblastoma:

               -  Progressive or recurrent disease after prior radiotherapy (with or without
                  chemotherapy)

               -  Patients with a previous low-grade glioma that progressed after prior
                  radiotherapy (with or without chemotherapy) and are found to have glioblastoma by
                  biopsy are eligible

          -  Measurable disease, defined as contrast-enhancing progressive or recurrent
             glioblastoma by MRI or CT imaging within the past 2 weeks

          -  Must be maintained on a stable corticosteroid regimen from the time of baseline scan
             to the start of study treatment

          -  Feasibility study only:

               -  Planning to undergo surgical resection or biopsy

               -  Stereotactic biopsy for confirmation of tumor progression or differentiation of
                  tumor progression from treatment-induced effects allowed

               -  Corticosteroids must be tapered to the lowest required steroid dose and patient
                  must be maintained on a stable dose after surgery or biopsy

          -  Karnofsky performance status 60-100%

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Hemoglobin >= 10 mg/dL

          -  Bilirubin =< 1.5 mg/dL

          -  AST and ALT =< 4 times upper limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

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

          -  Mini Mental State Exam score >= 15

          -  Mean QTc =< 500 msec (with Bazett's correction) by screening electrocardiogram

          -  LVEF >= 40%

          -  No history of familial long QT syndrome

          -  No myocardial infarction within the past 6 months

          -  No severe uncontrolled ventricular arrhythmias

          -  No uncontrolled angina

          -  No electrocardiographic evidence of acute ischemia or active conduction system
             abnormalities

          -  No ongoing vomiting or nausea >= grade 2

          -  No gastrointestinal tract disease resulting in an inability to take oral medication or
             a requirement for intravenous alimentation

          -  No active peptic ulcer disease

          -  No other condition that would impair ability to swallow pills or absorb oral
             medications

          -  No muscular dystrophy

          -  No myasthenia gravis

          -  No other known or suspected primary muscular or neuromuscular disease

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to tandutinib (e.g., erlotinib hydrochloride, gefetinib, or
             doxazosin mesylate)

          -  Patients who developed an acneiform/maculopustular rash while receiving either
             gefitinib or erlotinib hydrochloride are eligible unless the rash is considered an
             allergic reaction (angioedema/urticaria) or Stevens-Johnson syndrome

          -  No ongoing or active infections

          -  No psychiatric illness or social situations that would preclude study compliance

          -  No other serious infection or medical illness

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

          -  No other uncontrolled illness

          -  No other malignancy within the past 5 years except for basal cell or squamous cell
             skin cancer or carcinoma in situ of the cervix or breast

          -  Recovered from prior therapy

          -  At least 3 months since prior radiotherapy

          -  No prior surgical procedures affecting absorption

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No concurrent agent that would cause QTc prolongation

          -  No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim
             [GM-CSF])

          -  At least 10 days since prior and no concurrent anticonvulsant drugs that induce
             hepatic metabolic enzymes (e.g., primidone, oxcarbazepine, phenytoin, carbamazepine,
             or phenobarbital)

          -  No prior treatment with small molecule inhibitors of platelet-derived growth factor
             receptor (e.g., sunitinib malate, sorafenib, or imatinib mesylate)

          -  Platelet count >= 100,000/mm^3

          -  No New York Heart Association class III or IV heart failure

          -  Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60mL/min