Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01204749
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 26, 2010
First Posted Date  ICMJE September 17, 2010
Last Update Posted Date December 15, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
Progression-Free Survival [ Time Frame: 8 Months on average ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01204749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2010)
  • Overall survival [ Time Frame: 20 months on average ]
  • Objective Response Rate [ Time Frame: From Baseline (if subject has Measurable Disease) until objective response (radiologic) ]
  • Duration of response [ Time Frame: From Baseline until progression ]
  • CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125 [ Time Frame: From Baseline until CA-125 response ]
  • Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 8 Months on average ]
  • Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: Week 1 until week 9 of treatment ]
  • Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: 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) [ Time Frame: From week 1 until 30-days following last study drug administration ]
  • Overall health status using EuroQOL(EQ-5D) [ Time Frame: From week 1 until 30-days following last study drug administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
Intervention  ICMJE
  • Drug: AMG 386
    Weekly Intravenous (IV) AMG 386 15 mg/kg
    Other Name: Angiogenesis inhibitor
  • Drug: AMG 386 Placebo
    Weekly Intravenous (IV) placebo 15 mg/kg
    Other Name: Placebo comparator
  • Drug: Paclitaxel
    Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
    Other Name: Taxol USPI, 2007; Taxol SPC, 2009
Study Arms  ICMJE
  • Experimental: AMG 386
    Arm A: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 15mg/kg IV QW
    Interventions:
    • Drug: AMG 386
    • Drug: Paclitaxel
  • Placebo Comparator: AMG 386 Placebo
    Arm B: Paclitaxel 80mg/m2 IV QW and Blinded AMG 386 Placebo IV QW
    Interventions:
    • Drug: AMG 386 Placebo
    • Drug: Paclitaxel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
919
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2010)
900
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01204749
Other Study ID Numbers  ICMJE 20090508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP