Study Stopped
Closure of long term follow up (LTFU) and study earlier than previously outlined in the protocol as no beneficial information gained from continuing LTFU.
AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)
A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
4 other identifiers
interventional
223
17 countries
100
Brief Summary
To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS) The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2011
Longer than P75 for phase_3
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedStudy Start
First participant enrolled
April 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2017
CompletedDecember 2, 2017
November 1, 2017
3.4 years
January 20, 2011
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications
Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.
Secondary Outcomes (1)
• To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival
weekly
Study Arms (2)
Placebo plus PLD
PLACEBO COMPARATORArm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
AMG386 plus PLD
EXPERIMENTALArm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
Interventions
AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
- Female 18 years of age or older at the time the written informed consent is obtained
- Adequate organ and hematological function
You may not qualify if:
- Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
- Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
- Subjects with primary platinum-refractory disease
- Subjects with platinum-free interval (PFI) \> 12 months from their last platinum based therapy
- History of central nervous system metastasis
- Major surgery within 28 days prior to randomization or still recovering from prior surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (106)
Research Site
Los Angeles, California, 90027, United States
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San Francisco, California, 94143, United States
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Norwalk, Connecticut, 06856, United States
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Stamford, Connecticut, 06902, United States
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Orlando, Florida, 32806, United States
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Tampa, Florida, 33612, United States
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Evanston, Illinois, 60201, United States
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Saint Louis Park, Minnesota, 55426, United States
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New York, New York, 10029, United States
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Asheville, North Carolina, 28806, United States
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Durham, North Carolina, 27710, United States
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Winston-Salem, North Carolina, 27103, United States
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Bismarck, North Dakota, 58501, United States
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Abington, Pennsylvania, 19001, United States
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Sioux Falls, South Dakota, 57104, United States
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Fort Sam Houston, Texas, 78234, United States
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San Antonio, Texas, 78229, United States
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Annandale, Virginia, 22003, United States
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Green Bay, Wisconsin, 54301, United States
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Milwaukee, Wisconsin, 53215, United States
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West Allis, Wisconsin, 53227, United States
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New Lambton Heights, New South Wales, 2305, Australia
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Wahroonga, New South Wales, 2076, Australia
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Auchenflower, Queensland, 4066, Australia
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Greenslopes, Queensland, 4120, Australia
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East Bentleigh, Victoria, 3165, Australia
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Footscray, Victoria, 3011, Australia
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Malvern, Victoria, 3144, Australia
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Parkville, Victoria, 3052, Australia
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Graz, 8020, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Vienna, 1090, Austria
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Vienna, 1160, Austria
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Ieper, 8900, Belgium
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Leuven, 3000, Belgium
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Libramont, 6800, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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London, Ontario, N6A 4L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Copenhagen, 2100, Denmark
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Herlev, 2730, Denmark
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Amiens, 80000, France
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Avignon, 84918, France
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Lyon, 69373, France
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Poitiers, 86021, France
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Saint-Cloud, 92210, France
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Berlin, 13353, Germany
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Bonn, 53105, Germany
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Düsseldorf, 40217, Germany
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Erlangen, 91054, Germany
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Essen, 45136, Germany
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Frankfurt am Main, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Hanover, 30177, Germany
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Marburg, 35043, Germany
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München, 81377, Germany
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München, 81675, Germany
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Rostock, 18059, Germany
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Tübingen, 72076, Germany
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Budapest, 1032, Hungary
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Budapest, 1062, Hungary
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Debrecen, 4032, Hungary
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Miskolc, 3526, Hungary
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Szeged, 6720, Hungary
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Zalaegerszeg - Pozva, 8900, Hungary
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Campobasso, 86100, Italy
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Genova, 16128, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Roma, 00128, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Grafton, Auckland, 1023, New Zealand
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Tauranga, 3143, New Zealand
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Bialystok, 15-027, Poland
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Gdansk, 80-219, Poland
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Singapore, 169610, Singapore
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Singapore, 229899, Singapore
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Bratislava, 812 50, Slovakia
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Bratislava, 831 01, Slovakia
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Košice, 041 91, Slovakia
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Prešov, 080 01, Slovakia
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Aarau, 5001, Switzerland
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Chur, 7000, Switzerland
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Geneva, 1211, Switzerland
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Zurich, 8091, Switzerland
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Tainan, 70403, Taiwan
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Taipei, 10041, Taiwan
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Taipei, 10449, Taiwan
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London, NW1 2PG, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Poole, BH15 2JB, United Kingdom
Related Publications (3)
Marth C, Vergote I, Scambia G, Oberaigner W, Clamp A, Berger R, Kurzeder C, Colombo N, Vuylsteke P, Lorusso D, Hall M, Renard V, Pignata S, Kristeleit R, Altintas S, Rustin G, Wenham RM, Mirza MR, Fong PC, Oza A, Monk BJ, Ma H, Vogl FD, Bach BA. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. Eur J Cancer. 2017 Jan;70:111-121. doi: 10.1016/j.ejca.2016.09.004. Epub 2016 Dec 1.
PMID: 27914241BACKGROUNDNewhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PMID: 37407274DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
April 18, 2011
Primary Completion
August 29, 2014
Study Completion
April 19, 2017
Last Updated
December 2, 2017
Record last verified: 2017-11