Clinical trial NCT00583674 (phase 2, status: completed)
Conditions: gastrointestinal cancer
ICD codes: C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9
Drugs: amg 386 placebo, amg 386 10mg/kg, amg 386 3mg/kg, cisplatin, capecitabine, cisplatin, capecitabine, cisplatin, capecitabine
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Disease Related

               -  Histologically or cytologically confirmed adenocarcinoma of the stomach,
                  gastroesophageal junction or distal esophagus with metastatic disease

               -  Measurable or non-measurable disease per RECIST Guidelines

               -  Prior gastrectomy (total or partial) may be allowed as long as subjects can take
                  oral medications and meet all other inclusion/exclusion criteria. Subjects may
                  not take crushed or dissolved capecitabine via a feeding/gastrostomy tube

               -  Palliative radiotherapy for metastatic esophageal or gastric cancer prior to
                  study entry may be allowed as long as all toxicities from radiotherapy have
                  resolved and the radiotherapy was not to the only site of known metastatic
                  disease

          -  Demographic

             •18 years of age or older at the time the written informed consent is obtained

          -  General

               -  Able to swallow oral medication

               -  ECOG performance status of 0 or 1

          -  Laboratory

               -  Adequate organ and hematological function as evidenced by laboratory studies
                  prior to randomization

        Exclusion Criteria:

          -  Disease Related

               -  Prior chemotherapy for metastatic disease (1st line)

               -  Less than 12 months have elapsed from completion of previous adjuvant or
                  neoadjuvant chemotherapy or chemoradiotherapy

               -  Subjects with persistent gastric outlet obstruction, complete dysphagia or
                  feeding jejunostomy

               -  Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from
                  all radiotherapy-related toxicities

               -  Current or prior history of central nervous system metastases

               -  History of arterial or deep venous thromboembolism within 12 months prior to
                  randomization

               -  History of bleeding diathesis or clinically significant bleeding within 6 months
                  prior to randomization

               -  Major surgical procedure within 28 days prior to randomization

               -  Minor surgical procedure, placement of central venous access device or fine
                  needle aspiration within 3 days prior to randomization

               -  Prior malignancy except: malignancy treated with curative intent and without
                  evidence of active disease for ≥ 3 years prior to randomization and felt to be at
                  low risk for recurrence by treating physician, adequately treated
                  non-melanomatous skin cancer or lentigo maligna without evidence of disease,
                  adequately treated cervical carcinoma in situ without evidence of disease,
                  prostatic intraepithelial neoplasia without evidence of prostate cancer

               -  Prior malignancy (other than in situ cervical cancer, or basal cell cancer of the
                  skin) unless treated with curative intent and without evidence of disease for ≥ 3
                  years prior to randomization

               -  Clinically significant cardiovascular diseases within 12 months prior to
                  randomization

               -  Presence of clinically significant non-healing wound, ulcer (including
                  gastrointestinal) or fracture as judged by the investigator

               -  Ongoing or clinically significant active infection as judged by the investigator

               -  Known hypersensitivity to bacterial proteins, or any of the drugs required in
                  this study

               -  Known peripheral neuropathy ≥Grade 1

               -  Known dihydropyrimidine dehydrogenase deficiency

               -  Known hypersensitivity to 5-FU/capecitabine

               -  Known positive test for human immunodeficiency virus (HIV), hepatitis C, or
                  hepatitis B surface antigen

               -  Known active or chronic hepatitis

          -  Medications

               -  Currently or previously treated with angiopoietin inhibitors, or inhibitors of
                  TIE-1 or TIE-2

               -  Treatment with immune modulators such as cyclosporine or tacrolimus within 30
                  days prior to randomization

               -  Treatment with sorivudine or its chemically related analogues

               -  Anticoagulants (other than aspirin and anti-platelet agents) within 7 days prior
                  to randomization. The concurrent use of low molecular weight heparin or
                  heparanoids or low dose warfarin (i.e, ≤ 1 mg daily) for prophylaxis against
                  thrombosis is acceptable while on study

          -  General

               -  Not yet completed at least 30 days since ending other investigational device/drug
                  trial(s), or subject is receiving other investigational treatments

               -  Pregnant or is breast feeding