Clinical trial NCT00607594 (phase 2, status: completed)
Conditions: adenocarcinoma of the gastroesophageal junction, adenocarcinoma of the stomach, recurrent gastric cancer, stage iii gastric cancer, stage iii esophageal cancer, stage iv esophageal cancer, stage iv gastric cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: saracatinib
SMILES: CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the stomach or
             gastroesophageal junction (GEJ)

               -  Tumors of the GEJ must be sub-specified as type I, II, or III using the Siewert
                  classification

          -  Metastatic or locally advanced disease

               -  Patients with local/regional disease only, must have unresectable disease

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or
             as ≥ 10 mm by spiral computed tomography (CT) scan

          -  No known brain metastases

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS
             60-100%

          -  Life expectancy > 3 months

          -  Platelet count ≥ 100,000/mm³

          -  Leukocytes ≥ 3,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Hemoglobin > 9 g/dL

          -  Total bilirubin normal

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper
             limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Urine protein creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine
             collection

        Exclusion Criteria:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No condition that potentially impairs the ability to swallow or absorb AZD0530,
             including any of the following:

               -  Gastrointestinal tract disease resulting in an inability to take oral medication
                  or a requirement for IV alimentation

               -  Active peptic ulcer disease

               -  Short gut syndrome

               -  Malabsorption syndrome of any type

               -  Total or partial bowel obstruction

               -  Inability to tolerate oral medications

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to AZD0530

          -  No QTc prolongation (defined as a QTc interval ≥ 460 msec) or other significant
             electrocardiogram (ECG) abnormalities

          -  No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or
             diastolic BP ≥ 90 mm Hg)

          -  No history of ischemic heart disease, including myocardial infarction

          -  No concurrent cardiac dysfunction including, but not limited to, any of the following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

          -  No other concurrent uncontrolled illness, including ongoing or active infection or
             psychiatric illness/social situations, that would limit compliance with study
             requirements

          -  Prior chemotherapy allowed provided it was administered as part of initial curative
             intent therapy (i.e., neoadjuvant therapy, adjuvant therapy and/or concurrently with
             radiotherapy) in combination with surgery

               -  At least 4 weeks since prior chemotherapy

          -  At least 4 weeks since prior and no more than 1 line of palliative chemotherapy for
             advanced disease

          -  At least 4 weeks since prior radiotherapy and recovered

          -  At least 4 weeks since prior major surgery and recovered

          -  No cytochrome 450 3A4 (CYP3A4) active agents or substances for ≥ 7 days before,
             during, and for ≥ 7 days after completion of study treatment

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  No concurrent combination antiretroviral therapy for human immunodeficiency virus
             (HIV)-positive patients