Fallopian Tube CancerPhase 3NCT01281254
AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)
A Phase 3 study testing AMG386 plus PLD in people with Fallopian Tube Cancer and Ovarian Cancer, run by Amgen at 106 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
- What is being tested?
- AMG386 plus PLD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 106 sitesin 18 countries
- Study dates
- 18 Apr 2011to 19 Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
106 sites in 18 countries.
106 sites in 18 countries
United States21 sites
Research Site
Abington, Pennsylvania, 19001
Research Site
Annandale, Virginia, 22003
Research Site
Asheville, North Carolina, 28806
Research Site
Bismarck, North Dakota, 58501
Research Site
Durham, North Carolina, 27710
Research Site
Evanston, Illinois, 60201
Research Site
Fort Sam Houston, Texas, 78234
Research Site
Green Bay, Wisconsin, 54301
Research Site
Los Angeles, California, 90027
Research Site
Milwaukee, Wisconsin, 53215
Research Site
New York, New York, 10029
Research Site
Norwalk, Connecticut, 06856
Research Site
Orlando, Florida, 32806
Research Site
Saint Louis Park, Minnesota, 55426
Research Site
San Antonio, Texas, 78229
Research Site
San Francisco, California, 94143
Research Site
Sioux Falls, South Dakota, 57104
Research Site
Stamford, Connecticut, 06902
Research Site
Tampa, Florida, 33612
Research Site
West Allis, Wisconsin, 53227
Research Site
Winston-Salem, North Carolina, 27103
Germany13 sites
Research Site
Berlin, 13353
Research Site
Bonn, 53105
Research Site
Düsseldorf, 40217
Research Site
Erlangen, 91054
Research Site
Essen, 45136
Research Site
Frankfurt am Main, 60590
Research Site
Freiburg im Breisgau, 79106
Research Site
Hanover, 30177
Research Site
Marburg, 35043
Research Site
München, 81377
Research Site
München, 81675
Research Site
Rostock, 18059
Research Site
Tübingen, 72076
Australia8 sites
Research Site
Auchenflower, Queensland, 4066
Research Site
East Bentleigh, Victoria, 3165
Research Site
Footscray, Victoria, 3011
Research Site
Greenslopes, Queensland, 4120
Research Site
Malvern, Victoria, 3144
Research Site
New Lambton Heights, New South Wales, 2305
Research Site
Parkville, Victoria, 3052
Research Site
Wahroonga, New South Wales, 2076
Belgium8 sites
Research Site
Charleroi, 6000
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Ieper, 8900
Research Site
Leuven, 3000
Research Site
Libramont, 6800
Research Site
Liège, 4000
Research Site
Namur, 5000
Italy8 sites
Research Site
Campobasso, 86100
Research Site
Genova, 16128
Research Site
Milan, 20133
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Roma, 00128
Research Site
Roma, 00161
Research Site
Roma, 00168
United Kingdom7 sites
Research Site
London, NW1 2PG
Research Site
London, SE1 9RT
Research Site
London, SW3 6JJ
Research Site
Manchester, M20 4BX
Research Site
Northwood, HA6 2RN
Research Site
Nottingham, NG5 1PB
Research Site
Poole, BH15 2JB
Austria6 sites
Research Site
Graz, 8020
Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Linz, 4010
Research Site
Vienna, 1090
Research Site
Vienna, 1160
Hungary6 sites
Research Site
Budapest, 1032
Research Site
Budapest, 1062
Research Site
Debrecen, 4032
Research Site
Miskolc, 3526
Research Site
Szeged, 6720
Research Site
Zalaegerszeg - Pozva, 8900
France5 sites
Research Site
Amiens, 80000
Research Site
Avignon, 84918
Research Site
Lyon, 69373
Research Site
Poitiers, 86021
Research Site
Saint-Cloud, 92210
Slovakia4 sites
Research Site
Bratislava, 812 50
Research Site
Bratislava, 831 01
Research Site
Košice, 041 91
Research Site
Prešov, 080 01
Switzerland4 sites
Research Site
Aarau, 5001
Research Site
Chur, 7000
Research Site
Geneva, 1211
Research Site
Zurich, 8091
Canada3 sites
Research Site
London, Ontario, N6A 4L6
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
Taiwan3 sites
Research Site
Tainan, 70403
Research Site
Taipei, 10041
Research Site
Taipei, 10449
New Zealand2 sites
Research Site
Grafton, Auckland, 1023
Research Site
Tauranga, 3143
Singapore2 sites
Research Site
Singapore, 169610
Research Site
Singapore, 229899
About this study
Official title: 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
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.
- Being tested
- AMG386 plus PLD, Placebo plus PLD
- Keywords
- Fallopian tube cancer, Primary peritoneal cancer, AMG386, Pegylated Liposomal Doxorubicin, Recurrent epithelial ovarian cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG386 plus PLDDrug
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)
Placebo plus PLDDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo plus PLD | Placebo comparator | Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW) Receives: Drug: Placebo plus PLD |
| AMG386 plus PLD | Experimental | Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW) Receives: Drug: AMG386 plus PLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study start18 Apr 2011
- Primary completion29 Aug 2014
- Study completion19 Apr 2017
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281254
- Sponsor's protocol ID
- 20060517
- Other IDs
- 2009-017946-30, ENGOT-ov-6, TRINOVA-2, 20060517, 2009
- Status last verified
- Nov 2017
- First submitted
- 20 Jan 2011
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27914241Newhouse 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.
PubMed 37407274Gaitskell 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.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01281254
- Acronym / sponsor ID
- 20060517
- Keywords
- Fallopian tube cancer, Primary peritoneal cancer, AMG386, Pegylated Liposomal Doxorubicin, Recurrent epithelial ovarian cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 223 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2011 (actual)
- Primary completion
- 29 Aug 2014 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo plus PLD | Placebo comparator | Drug: Placebo plus PLDArm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW) |
| AMG386 plus PLD | Experimental | Drug: AMG386 plus PLDArm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG386 plus PLDAMG 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) | Drug | AMG386 plus PLD |
| Placebo plus PLDPegylated 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) | Drug | Placebo plus PLD |
Primary outcome
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
Time frame: 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.
1 secondary outcome
• To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival
Time frame: weekly
Results and safety
The study was stopped early (reason given: Closure of long term follow up (LTFU) and study earlier than previously outlined in the protocol as no beneficial information gained from continuing LTFU.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Background: PubMed 27914241Marth 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.
- Derived from this study: PubMed 37407274Newhouse 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.
- Derived from this study: PubMed 37185961Gaitskell 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
106 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMG386 plus PLD in people with Fallopian Tube Cancer and Ovarian Cancer, run by Amgen at 106 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Germany, Australia, Belgium, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closure of long term follow up (LTFU) and study earlier than previously outlined in the protocol as no beneficial information gained from continuing LTFU.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281254, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.