Ovarian Cancer Clinical Trial
Official title:
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
| Verified date | February 2017 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 1015 |
| Est. completion date | December 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Graz | |
| Austria | Research Site | Graz | |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Salzburg | |
| Austria | Research Site | Wien | |
| Belgium | Research Site | Bonheiden | |
| Belgium | Research Site | Brasschaat | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Charleroi | |
| Belgium | Research Site | Duffel | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Kortrijk | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Libramont | |
| Belgium | Research Site | Liège | |
| Belgium | Research Site | Namur | |
| Belgium | Research Site | Oostende | |
| Belgium | Research Site | Sint-Niklaas | |
| Belgium | Research Site | Turnhout | |
| Belgium | Research Site | Wilrijk | |
| Belgium | Research Site | Yvoir | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Kingston | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Sault Ste. Marie | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Denmark | Research Site | Herlev | |
| Denmark | Research Site | København Ø | |
| Denmark | Research Site | Roskilde | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Düsseldorf | |
| Germany | Research Site | Düsseldorf | |
| Germany | Research Site | Erlangen | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Frankfurt am Main | |
| Germany | Research Site | Frankfurt am Main | |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Kiel | |
| Germany | Research Site | Konstanz | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Ludwigsburg | |
| Germany | Research Site | München | |
| Germany | Research Site | München | |
| Germany | Research Site | München | |
| Germany | Research Site | Oldenburg | |
| Germany | Research Site | Ravensburg | |
| Germany | Research Site | Rostock | |
| Germany | Research Site | Stuttgart | |
| Germany | Research Site | Tübingen | |
| Germany | Research Site | Ulm | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Larissa | |
| Greece | Research Site | Patra | |
| Greece | Research Site | Thessaloniki | |
| Hong Kong | Research Site | Hong Kong | |
| Hong Kong | Research Site | Kowloon | |
| Hong Kong | Research Site | New Territories | |
| Italy | Research Site | Avellino | |
| Italy | Research Site | Aviano PN | |
| Italy | Research Site | Bari | |
| Italy | Research Site | Bologna | |
| Italy | Research Site | Brescia | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Novara | |
| Italy | Research Site | Palermo | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Torino | |
| Japan | Research Site | Fukuoka-shi | Fukuoka |
| Japan | Research Site | Kashiwa | Chiba |
| Japan | Research Site | Kitaadachi-gun | Saitama |
| Japan | Research Site | Kure-city | Hiroshima |
| Japan | Research Site | Kurume-city | Fukuoka |
| Japan | Research Site | Morioka-city | Iwate |
| Japan | Research Site | Nagoya-city | Aichi |
| Japan | Research Site | Sapporo-city | Hokkaido |
| Japan | Research Site | Suntou-gun | Shizuoka |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Yonago-city | Tottori |
| Korea, Republic of | Research Site | Goyang-si, Gyeonggi-do | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Netherlands | Research Site | Deventer | |
| Netherlands | Research Site | Leiden | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Russian Federation | Research Site | Chelyabinsk | |
| Russian Federation | Research Site | Ivanovo | |
| Russian Federation | Research Site | Krasnodar | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Obninsk | |
| Russian Federation | Research Site | Pyatigorsk | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Voronezh | |
| Spain | Research Site | Badalona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | El Palmar | Murcia |
| Spain | Research Site | Girona | Cataluña |
| Spain | Research Site | Lleida | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Oviedo | Asturias |
| Spain | Research Site | Palma de Mallorca | Baleares |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Spain | Research Site | Zaragoza | Aragón |
| United States | Research Site | Abington | Pennsylvania |
| United States | Research Site | Akron | Ohio |
| United States | Research Site | Albany | New York |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Ames | Iowa |
| United States | Research Site | Anchorage | Alaska |
| United States | Research Site | Annandale | Virginia |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Augusta | Georgia |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
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| United States | Research Site | Bend | Oregon |
| United States | Research Site | Berkeley | California |
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| United States | Research Site | Bridgeport | Connecticut |
| United States | Research Site | Brightwaters | New York |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Burbank | California |
| United States | Research Site | Burlington | Massachusetts |
| United States | Research Site | Burlington | North Carolina |
| United States | Research Site | Burlington | Vermont |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Charlottesville | Virginia |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chicago | Illinois |
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| United States | Research Site | Cincinnati | Ohio |
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| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbia | South Carolina |
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| United States | Research Site | Concord | North Carolina |
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| United States | Research Site | Covington | Louisiana |
| United States | Research Site | Dallas | Texas |
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| United States | Research Site | Danvers | Massachusetts |
| United States | Research Site | Decatur | Illinois |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Edgewood | Kentucky |
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| United States | Research Site | Evanston | Illinois |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Farmington | Connecticut |
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| United States | Research Site | Gilbert | Arizona |
| United States | Research Site | Green Bay | Wisconsin |
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| United States | Research Site | Greenville | South Carolina |
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| United States | Research Site | Hackensack | New Jersey |
| United States | Research Site | Hartford | Connecticut |
| United States | Research Site | Hinsdale | Illinois |
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| United States | Research Site | Joliet | Illinois |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Kansas City | Kansas |
| United States | Research Site | Kettering | Ohio |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Lafayette | Louisiana |
| United States | Research Site | Lake Success | New York |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lebanon | New Hampshire |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Macon | Georgia |
| United States | Research Site | Marshfield | Wisconsin |
| United States | Research Site | Mayfield Heights | Ohio |
| United States | Research Site | Maywood | Illinois |
| United States | Research Site | Miami | Florida |
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| United States | Research Site | Neptune | New Jersey |
| United States | Research Site | New Britain | Connecticut |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Oak Lawn | Illinois |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Orange | California |
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| United States | Research Site | Orlando | Florida |
| United States | Research Site | Oshkosh | Wisconsin |
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| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Radnor | Pennsylvania |
| United States | Research Site | Rancho Mirage | California |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Roanoke | Virginia |
| United States | Research Site | Rochester | Minnesota |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Sacramento | California |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Scarborough | Maine |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Sheboygan | Wisconsin |
| United States | Research Site | Sioux Falls | South Dakota |
| United States | Research Site | South Bend | Indiana |
| United States | Research Site | St Louis | Missouri |
| United States | Research Site | St Petersburg | Florida |
| United States | Research Site | St. Louis Park | Minnesota |
| United States | Research Site | Stamford | Connecticut |
| United States | Research Site | Syracuse | New York |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | The Woodlands | Texas |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Urbana | Illinois |
| United States | Research Site | Voorhees | New Jersey |
| United States | Research Site | Waukesha | Wisconsin |
| United States | Research Site | Wausau | Wisconsin |
| United States | Research Site | Wenatchee | Washington |
| United States | Research Site | West Allis | Wisconsin |
| United States | Research Site | West Reading | Pennsylvania |
| United States | Research Site | Wilmington | North Carolina |
| United States | Research Site | Winchester | Virginia |
| United States | Research Site | Winston Salem | North Carolina |
| United States | Research Site | Winston Salem | North Carolina |
| United States | Research Site | Woodbridge | Virginia |
| United States | Research Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Austria, Belgium, Canada, Denmark, Germany, Greece, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Spain,
Fujiwara K, Monk BJ, Lhommé C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-13. doi: 10.1093/annonc/mdw147. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival | 3 years | ||
| Secondary | Overall survival (OS) | 5 years | ||
| Secondary | Incidence of adverse events and significant laboratory abnormalities | 4 years | ||
| Secondary | Pharmacokinetics of AMG 386 (Cmax and Cmin) | pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7 | 1 year | |
| Secondary | Incidence of anti-AMG 386 antibody formation | pre-dose weeks 1, 10, 19 | 4 years | |
| Secondary | Patient reported ovarian cancer-specific symptoms and health related quality of life | 4 years | ||
| Secondary | Patient reported status as measured by the EuroQOL (EQ-5D) | 4 years | ||
| Secondary | AMG 386 exposure-response relationships for PFS and OS | 4 years | ||
| Secondary | Correlation of serum biomarkers with measures of response | 4 years |
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