TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Not Recruiting

Trial ID: NCT01204749


The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Official Title

A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

Stanford Investigator(s)

Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc

Laurie Kraus Lacob Professor


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

   - 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

   - Clinically significant cardiovascular disease within 12 months prior to randomization

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

   - 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.


drug: AMG 386

drug: AMG 386 Placebo

drug: Paclitaxel

drug: Paclitaxel

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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