TRINOVA-2: Trebananib in Ovarian Cancer-2
This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01281254
First received: January 20, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cancer |
Drug: AMG386 plus PLD Drug: Placebo plus PLD |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival [ Time Frame: weekly ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 380 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo plus PLD
Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
|
Drug: Placebo plus PLD
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) |
|
Experimental: AMG386 plus PLD
Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
|
Drug: AMG386 plus PLD
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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281254
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Contacts
| Contact: Amgen Call Center | 866-572-6436 |
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| United States, California | |
| Research Site | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Research Site | Recruiting |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Research Site | Recruiting |
| Norwalk, Connecticut, United States, 06856 | |
| Research Site | Completed |
| Stamford, Connecticut, United States, 06902 | |
| United States, Florida | |
| Research Site | Completed |
| Orlando, Florida, United States, 32806 | |
| Research Site | Recruiting |
| Tampa, Florida, United States, 33612 | |
| United States, Minnesota | |
| Research Site | Completed |
| St. Louis Park, Minnesota, United States, 55426 | |
| United States, New York | |
| Research Site | Recruiting |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Research Site | Completed |
| Asheville, North Carolina, United States, 28806 | |
| United States, North Dakota | |
| Research Site | Completed |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Pennsylvania | |
| Research Site | Recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| United States, South Dakota | |
| Research Site | Recruiting |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| Research Site | Completed |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Research Site | Completed |
| Annandale, Virginia, United States, 22003 | |
| United States, Wisconsin | |
| Research Site | Recruiting |
| Green Bay, Wisconsin, United States, 54301 | |
| Australia, New South Wales | |
| Research Site | Recruiting |
| New Lambton Heights, New South Wales, Australia, 2305 | |
| Research Site | Recruiting |
| Wahroonga, New South Wales, Australia, 2076 | |
| Australia, Queensland | |
| Research Site | Recruiting |
| Auchenflower, Queensland, Australia, 4066 | |
| Research Site | Completed |
| Auchenflower, Queensland, Australia, 4066 | |
| Research Site | Recruiting |
| Greenslopes, Queensland, Australia, 4120 | |
| Australia, Victoria | |
| Research Site | Recruiting |
| Footscray, Victoria, Australia, 3011 | |
| Research Site | Recruiting |
| Parkville, Victoria, Australia, 3052 | |
| Austria | |
| Research Site | Recruiting |
| Graz, Austria, 8036 | |
| Research Site | Recruiting |
| Graz, Austria, 8020 | |
| Research Site | Recruiting |
| Innsbruck, Austria, 6020 | |
| Research Site | Recruiting |
| Linz, Austria, 4010 | |
| Research Site | Recruiting |
| Wien, Austria, 1160 | |
| Belgium | |
| Research Site | Recruiting |
| Charleroi, Belgium, 6000 | |
| Research Site | Recruiting |
| Edegem, Belgium, 2650 | |
| Research Site | Recruiting |
| Gent, Belgium, 9000 | |
| Research Site | Recruiting |
| Ieper, Belgium, 8900 | |
| Research Site | Recruiting |
| Leuven, Belgium, 3000 | |
| Research Site | Recruiting |
| Libramont, Belgium, 6800 | |
| Research Site | Recruiting |
| Liège, Belgium, 4000 | |
| Research Site | Recruiting |
| Namur, Belgium, 5000 | |
| Denmark | |
| Research Site | Recruiting |
| Herlev, Denmark, 2730 | |
| Research Site | Recruiting |
| København, Denmark, 2100 | |
| Germany | |
| Research Site | Recruiting |
| Düsseldorf, Germany, 40217 | |
| Research Site | Recruiting |
| Essen, Germany, 45136 | |
| Research Site | Recruiting |
| Rostock, Germany, 18059 | |
| Hong Kong | |
| Research Site | Recruiting |
| Hong Kong, Hong Kong | |
| Research Site | Recruiting |
| New Territories, Hong Kong | |
| Hungary | |
| Research Site | Recruiting |
| Budapest, Hungary, 1032 | |
| Research Site | Recruiting |
| Budapest, Hungary, 1062 | |
| Research Site | Recruiting |
| Debercen, Hungary, 4032 | |
| Research Site | Recruiting |
| Miskolc, Hungary, 3526 | |
| Research Site | Recruiting |
| Szeged, Hungary, 6720 | |
| Research Site | Recruiting |
| Zalaegerszeg, Hungary, 8900 | |
| Research Site | Recruiting |
| Zalaegerszeg - Pozva, Hungary, 8900 | |
| Italy | |
| Research Site | Recruiting |
| Campobasso, Italy, 86100 | |
| Research Site | Recruiting |
| Milano, Italy, 20141 | |
| Research Site | Recruiting |
| Napoli, Italy, 80131 | |
| Research Site | Recruiting |
| Roma, Italy, 00168 | |
| Research Site | Recruiting |
| Roma, Italy, 00128 | |
| New Zealand | |
| Research Site | Recruiting |
| Tauranga, New Zealand, 3143 | |
| Singapore | |
| Research Site | Recruiting |
| Singapore, Singapore, 169610 | |
| Research Site | Recruiting |
| Singapore, Singapore, 229899 | |
| Slovakia | |
| Research Site | Recruiting |
| Bratislava, Slovakia, 812 50 | |
| Research Site | Recruiting |
| Bratislava, Slovakia, 831 01 | |
| Research Site | Recruiting |
| Kosice, Slovakia, 041 91 | |
| Research Site | Recruiting |
| Presov, Slovakia, 080 01 | |
| Taiwan | |
| Research Site | Recruiting |
| Tainan, Taiwan, 70403 | |
| Research Site | Recruiting |
| Taipei, Taiwan, 10041 | |
| Research Site | Recruiting |
| Taipei, Taiwan, 10449 | |
| United Kingdom | |
| Research Site | Recruiting |
| London, United Kingdom, NW1 2PG | |
| Research Site | Recruiting |
| London, United Kingdom, SE1 9RT | |
| Research Site | Recruiting |
| London, United Kingdom, SW3 6JJ | |
| Research Site | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Research Site | Recruiting |
| Northwood, United Kingdom, HA6 2RN | |
| Research Site | Recruiting |
| Nottingham, United Kingdom, NG5 1PB | |
| Research Site | Recruiting |
| Poole, United Kingdom, BH15 2JB | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01281254 History of Changes |
| Other Study ID Numbers: | 20060517, 2009-017946-30, ENGOT-ov-6, TRINOVA-2, 20060517 |
| Study First Received: | January 20, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Belgium: Grand Hôpital de Charleroi comité d'éthique Belgium: Jan Yperman ziekenhuis Ethisch Comité Belgium: UZ Antwerpen Ethisch Comite Denmark: Central Ethics Committee Denmark: Danish Medicines Agency Denmark: Laegemiddelstyrelsen Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte Belgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen KULeuven Germany: Bundesoberbehorde, BOB Germany: Ethics Committee Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe Hong Kong: Department of Health Hungary: Central Ethics Committee Hungary: National Institute of Pharmacy Italy: Agenzia Italiana del Farmaco Italy: COMITATO ETICO DELL´ENTE OSPEDALIERO OSPEDALI GALLIERA DI GENOVA Italy: Local Ethics Committees Italy: Ministry of Health Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies. New Zealand: Ethics Committee New Zealand: Medicines and Medical Devices Safety Authority Singapore: Health Science Authority Slovakia: Local Ethics Committees Slovakia: Ministry of Health Slovakia: State Institiute for Drug Control Slovakia: Štátny ústav pre kontrolu lieciv Taiwan: Taiwan Food and Drug Administration United Kingdom: Main Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration United States: Quorom Institutional Review Board Australia: Austin Health Human Research Ethics Committee Australia: Bellberry Human Research Ethics Committee Australia: Hunter New England Human Research Ethics Committee Australia:Melbourne Health Office for Research Austria: Bundesamt für Sicherheit im Gesundheitswesen Austria: Central Ethics Committee Belgium: AZ Sint-Lucas Ethisch Comite Belgium: Centre Hospitalier de l'Ardenne comité d'éthique Belgium: Centre Hospitalier Régional de La Citadelle comité d'éthique Belgium: Clinique Sainte Elisabeth comité d'éthique |
Keywords provided by Amgen:
|
Fallopian tube cancer Primary peritoneal cancer AMG386 Pegylated Liposomal Doxorubicin Recurrent epithelial ovarian cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013