Ovarian Cancer Clinical Trial
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
| Verified date | November 2017 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 223 |
| Est. completion date | April 19, 2017 |
| Est. primary completion date | August 29, 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Auchenflower | Queensland |
| Australia | Research Site | East Bentleigh | Victoria |
| Australia | Research Site | Footscray | Victoria |
| Australia | Research Site | Greenslopes | Queensland |
| Australia | Research Site | Malvern | Victoria |
| Australia | Research Site | New Lambton Heights | New South Wales |
| Australia | Research Site | Parkville | Victoria |
| Australia | Research Site | Wahroonga | New South Wales |
| Austria | Research Site | Graz | |
| Austria | Research Site | Graz | |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wien | |
| Belgium | Research Site | Charleroi | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Ieper | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Libramont | |
| Belgium | Research Site | Liège | |
| Belgium | Research Site | Namur | |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Denmark | Research Site | Herlev | |
| Denmark | Research Site | København | |
| France | Research Site | Amiens | |
| France | Research Site | Avignon cedex 9 | |
| France | Research Site | Lyon cedex 8 | |
| France | Research Site | Poitiers | |
| France | Research Site | Saint Cloud | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Bonn | |
| Germany | Research Site | Düsseldorf | |
| Germany | Research Site | Erlangen | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Frankfurt am Main | |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Marburg | |
| Germany | Research Site | München | |
| Germany | Research Site | München | |
| Germany | Research Site | Rostock | |
| Germany | Research Site | Tübingen | |
| Hong Kong | Research Site | Hong Kong | |
| Hong Kong | Research Site | New Territories | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Miskolc | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Zalaegerszeg - Pozva | |
| Italy | Research Site | Campobasso | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Roma | |
| New Zealand | Research Site | Grafton, Auckland | |
| New Zealand | Research Site | Tauranga | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Gdansk | |
| Singapore | Research Site | Singapore | |
| Singapore | Research Site | Singapore | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Presov | |
| Switzerland | Research Site | Aarau | |
| Switzerland | Research Site | Chur | |
| Switzerland | Research Site | Geneva 14 | |
| Switzerland | Research Site | Zurich | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Northwood | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Poole | |
| United States | Research Site | Abington | Pennsylvania |
| United States | Research Site | Annandale | Virginia |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Bismarck | North Dakota |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Evanston | Illinois |
| United States | Research Site | Fort Sam Houston | Texas |
| United States | Research Site | Green Bay | Wisconsin |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | New York | New York |
| United States | Research Site | Norwalk | Connecticut |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Saint Louis Park | Minnesota |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Sioux Falls | South Dakota |
| United States | Research Site | Stamford | Connecticut |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | West Allis | Wisconsin |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Hungary, Italy, New Zealand, Poland, Singapore, Slovakia, Switzerland, Taiwan, United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival | weekly |
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