Clinical trial NCT01204749 (phase 3, status: completed)
Conditions: fallopian tube cancer, ovarian cancer, primary peritoneal cancer
ICD codes: C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02
Drugs: amg 386, amg 386 placebo, paclitaxel, paclitaxel
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        Inclusion Criteria:

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

          -  Gynecologic Oncology Group (GOG) Performance Status of 0 or 1

          -  Life expectancy >= 3 months (per investigator opinion)

          -  Histologically or cytologically documented invasive epithelial ovarian cancer, primary
             peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma ,
             mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with
             borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with
             clear cell or mucinous histology are excluded)

          -  Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or
             fallopian tube cancer including at least a unilateral oophorectomy

          -  Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors
             (RECIST) 1.1 with modifications

          -  Subjects must have had one prior platinum-based chemotherapeutic regimen for
             management of primary disease containing carboplatin, cisplatin, or another
             organoplatinum compound. This initial treatment may have included intraperitoneal
             therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy
             administered after surgical or non-surgical assessment.

          -  Adequate organ and hematological function

          -  Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and
             diastolic blood pressure <= 90 mmHg prior to randomization. The use of
             anti-hypertensive medications to control hypertension is permitted

          -  Radiographically documented disease progression either on or following the last dose
             of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal
             cancer, or fallopian tube cancer

        Exclusion Criteria:

          -  Subjects who have received more than 3 previous regimens of anti-cancer therapy for
             epithelial ovarian, primary peritoneal or fallopian tube cancers

          -  Subjects who have received paclitaxel as consolidation therapy, maintenance, or
             monotherapy are excluded

          -  Subjects with primary platinum-refractory disease

          -  Subjects with platinum-free interval (PFI) > 12 months from their last platinum based
             therapy

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

          -  Previous abdominal or pelvic radiotherapy

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

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

          -  History of central nervous system metastasis

          -  Has not yet completed a 21 day washout period prior to randomization for any previous
             anti cancer systemic therapies (30 days for prior bevacizumab)

          -  Enrolled in or has not yet completed at least 30 days (prior to randomization) since
             ending other investigational device or drug, or currently receiving other
             investigational treatments

          -  Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria
             for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia

          -  Known active or ongoing infection (except uncomplicated urinary tract infection [UTI])
             within 14 days prior to randomization

          -  Currently or previously treated with AMG 386, or other molecules that inhibit the
             angiopoietins or Tie2 receptor

          -  Treatment within 30 days prior to randomization with strong immune modulators
             including but not limited to systemic cyclosporine, tacrolimus, sirolimus,
             mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and
             lenalidomide

          -  Clinically significant cardiovascular disease within 12 months prior to randomization

          -  Major surgery within 28 days prior to randomization or still recovering from prior
             surgery

          -  Minor surgical procedures, except placement of tunneled central venous access device
             within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor
             surgical procedure.