Clinical trial NCT00475150 (phase 2, status: completed)
Conditions: adult acute myeloid leukemia with 11q23 (mll) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, secondary myelodysplastic syndromes, untreated adult acute myeloid leukemia
ICD codes: R19.5, H35.09, M26.50, M26.59, Q99.8, R06.89, R06.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, D46.Z, D46.9, C94.6, D46.C, D46.Z, D46.9, C94.6, D46.C, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, D75.1, E26.1, N91.1, N91.4, N94.5, A51.41, A51.43, D46.Z, D46.9, C94.6, D46.C, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: cediranib maleate
SMILES: COC1=CC2=C(C=C1OCCCN1CCCC1)N=CN=C2OC1=C(F)C2=C(NC(C)=C2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed acute myeloid leukemia (AML)
             ormyelodysplastic syndromes meeting 1 of the following criteria:

               -  Relapsed AML meeting any of the following criteria:

                    -  Good-risk cytogenetics (inv[16], t[8;21], or t[15;17]) in second orgreater
                       relapse

                         -  Patients with AML t(15;17) must have failed prior tretinoin and
                            arsenic-containing regimens AND progressed orrelapsed within 12 months
                            of therapy

                    -  In first or greater relapse

               -  Resistant AML

                    -  Unable to achieve first complete remission after at least 2
                       inductionregimens

               -  Untreated AML meeting any of the following criteria:

                    -  At least 60 years of age

                    -  Preceding MDS

               -  MDS

                    -  International Prognosis Scoring System (IPSS) risk groupof intermediate-2 or
                       higher

          -  Patients with relapsed disease after allogeneic hematopoietic stem cell
             transplantation (HSCT) must be off allimmunosuppressive medications for at least 30
             days and have no symptoms orsigns of graft-vs-host disease

          -  No active CNS metastasis

               -  Patients with clinical signs of CNS disease or a history of CNS diseasewithin the
                  past 6 months are required to undergo lumbar puncture to excludeCNS involvement

          -  No symptomatic leukostasis or requirement for leukapheresis

          -  Not eligible for allogeneic HSCTAND no suitable donor at the time of study entry

               -  Patients who areeligible for HSCT, informed of the option, and choose not to
                  proceed to HSCTare allowed

          -  ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

          -  Bilirubin normal

          -  AST and/or ALT ≤ 2.5 times upper limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  No proteinuria ≥ 1+ on 2 consecutive urinalysis taken ≥ 1 week apart

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No HIV positivity

          -  LVEF ≥ 45% by echocardiography

          -  Mean QTc ≤ 500 msec (with Bazett's correction)

          -  No other significant ECG abnormality

          -  No history of familial long QT syndrome

          -  No disseminated intravascular coagulation

          -  No history of allergic reactions attributed to compounds of similar chemical
             orbiological composition to AZD2171

          -  No concurrent uncontrolled illness, including, but not limited to, any of the
             following:

               -  Hypertension

               -  Thyroid disease

               -  Ongoing or active infection

               -  Symptomatic congestive heartfailure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  NYHA class III-IV heart disease

                    -  NYHA class II heart disease controlled with treatment allowed

               -  Psychiatric illness or social situations that would limit study compliance

          -  See Disease Characteristics

          -  More than 4 weeks since prior chemotherapy (6 weeks fornitrosoureas or mitomycin C),
             radiotherapy, or major surgery and recovered

               -  Hydroxyurea allowed to control peripheral blast count> 20,000/mcL prior to study
                  entry and during the first 3 days of study therapy

          -  More than 4 weeks since prior and no concurrent growth factor or other cytokine
             support

          -  At least 30 days since prior investigational agents or participation in
             aninvestigational trial

          -  No more than 3 prior courses of induction chemotherapy

               -  Induction chemotherapyis defined as that intended to induce complete remission
                  and given at a time thatthe patient has active disease

          -  No concurrent CYP interactive medications

          -  No other concurrent investigational agents

          -  No concurrent drugs or biologics with proarrhythmic potential

          -  Prior and concurrent hydroxyurea allowed to control peripheral blast count> 20,000/mcL
             during the first 3 days of study therapy