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
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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Drug : AMG 386, Drug : AMG 386 Placebo, Drug : Paclitaxel, Drug : Paclitaxel

Study Arm Groups : AMG 386, AMG 386 Placebo, AMG 386, AMG 386 Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression-Free Survival; 8 Months on average
Secondary Outcome Measures
  • Overall survival; 20 months on average; Objective Response Rate; From Baseline (if subject has Measurable Disease) until objective response (radiologic); Duration of response; From Baseline until progression; CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125; From Baseline until CA-125 response; Incidence of adverse events and significant laboratory abnormalities; 8 Months on average; Pharmacokinetics of AMG 386 (Cmax and Cmin); Week 1 until week 9 of treatment; Incidence of the occurrence of anti-AMG 386 antibody formation; Week 1 until maximum of 1-year following last dose of study drug; Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy - Ovary questionnaire (FACT-O); From week 1 until 30-days following last study drug administration; Overall health status using EuroQOL(EQ-5D); From week 1 until 30-days following last study drug administration
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
18 Years - N/A
Who Can Participate
Number of Participants
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Christie Hospital NHS Foundation Trust
M20 4BX
Research Site
Research Site
Nottingham University Hospitals, City Campus
Research Site
BH15 2JB
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
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Countries Recruiting
Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Estonia, France, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Malaysia, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States
Scientific 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
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
Key Dates

Recruitment Start Date

Oct 2010

Recruitment End Date

Mar 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

26 Aug 2010

Last Updated

24 Aug 2015