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Trial record 2 of 3 for:    trinova 2

TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01493505
Recruitment Status : Terminated (Amgen Administrative Decision - termination of LTFU)
First Posted : December 16, 2011
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE September 29, 2011
First Posted Date  ICMJE December 16, 2011
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
Progression free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
  • Overall survival (OS) [ Time Frame: 5 years ]
  • Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 4 years ]
  • Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: 1 year ]
    pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
  • Incidence of anti-AMG 386 antibody formation [ Time Frame: 4 years ]
    pre-dose weeks 1, 10, 19
  • Patient reported ovarian cancer-specific symptoms and health related quality of life [ Time Frame: 4 years ]
  • Patient reported status as measured by the EuroQOL (EQ-5D) [ Time Frame: 4 years ]
  • AMG 386 exposure-response relationships for PFS and OS [ Time Frame: 4 years ]
  • Correlation of serum biomarkers with measures of response [ Time Frame: 4 years ]
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-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
Official Title  ICMJE A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Brief Summary The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
Intervention  ICMJE
  • Drug: AMG 386
    AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
  • Drug: Paclitaxel
    Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
  • Drug: AMG 386 Placebo
    AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
  • Drug: Carboplatin
    Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo Paclitaxel Carboplatin
    Interventions:
    • Drug: Paclitaxel
    • Drug: AMG 386 Placebo
    • Drug: Carboplatin
  • Active Comparator: AMG 386
    AMG 386 Paclitaxel Carboplatin
    Interventions:
    • Drug: AMG 386
    • Drug: Paclitaxel
    • Drug: Carboplatin
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 2, 2014)
1015
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2011)
2000
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
  • Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
  • Subjects with FIGO Stage IIIC or IV disease must either:
  • Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
  • Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
  • ECOG performance status of 0 or 1
  • Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

  • Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
  • Previous abdominal and/or pelvic external beam radiotherapy
  • History of central nervous metastasis
  • History of arterial or venous thromboembolism within 12 months prior to randomization
  • Clinically significant cardiovascular disease within 12 months prior to randomization
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 Austria,   Belgium,   Canada,   Denmark,   Germany,   Greece,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01493505
Other Study ID Numbers  ICMJE 20101129
TRINOVA-3 20101129/ENGOT-ov2
Has Data Monitoring Committee Not Provided
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 February 2017

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