Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

NCT00699374 | Terminated Phase 3 Results DMC

• 1 other identifier: A6181170
• Study Type: interventional
• Target: 1,075
• Locations: 23 countries
• Sites: 171

Brief Summary

The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

Conditions

Carcinoma, Hepatocellular

Keywords

sunitinib; phase 3; randomized; hepatocellular; liver

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

  Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

• Time to Tumor Progression (TTP)

  Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

• European Quality of Life (EQ-5D)- Health State Profile Utility Score

  Day 1 of each cycle

Study Arms (2)

Arm A

EXPERIMENTAL

sunitinib arm

Drug: sunitinib malate

Arm B

ACTIVE COMPARATOR

sorafenib arm

Drug: sorafenib

Interventions

sunitinib malate DRUG

sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.

Also known as: Sutent®

Arm A

sorafenib DRUG

sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.

Also known as: Nexavar®

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed diagnosis of hepatocellular carcinoma
• presence of measurable disease by radiographic imaging
• Child-Pugh class A
• ECOG PS 0 or 1
• adequate organ function.

You may not qualify if:

• Prior treatment with any systemic treatment for hepatocellular carcinoma
• prior local treatment within 4 weeks from entry
• presence of clinically relevant ascites
• severe hemorrhage \<4 weeks of starting study treatment
• known HIV or serious acute or chronic illness
• current treatment on another clinical trial
• pregnancy or breastfeeding

Sponsors & Collaborators

• Pfizer: lead

Study Sites (171)

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093, United States

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Orange, California, 92868, United States

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San Diego, California, 92103, United States

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Miami, Florida, 33136, United States

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Ringgold, Georgia, 30736, United States

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Iowa City, Iowa, 52242, United States

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Crestview Hills, Kentucky, 41017, United States

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The Bronx, New York, 10467, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45230, United States

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Cincinnati, Ohio, 45236, United States

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Cincinnati, Ohio, 45238, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45248, United States

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Fairfield, Ohio, 45014, United States

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Hamilton, Ohio, 45013, United States

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Chattanooga, Tennessee, 37404, United States

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Franklin, Tennessee, 37067, United States

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Gallatin, Tennessee, 37066, United States

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Hermitage, Tennessee, 37076, United States

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Hixson, Tennessee, 37343, United States

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Lebanon, Tennessee, 37087, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37207, United States

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Nashville, Tennessee, 37211, United States

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Smyrna, Tennessee, 37167, United States

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Mechanicsville, Virginia, 23116, United States

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Midlothian, Virginia, 23114, United States

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Richmond, Virginia, 23230, United States

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Richmond, Virginia, 23235-4730, United States

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Seattle, Washington, 98101, United States

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Concord, New South Wales, 2139, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Woodville South, South Australia, 5011, Australia

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Melbourne, Victoria, 3004, Australia

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Parkville, Victoria, 3050, Australia

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Ghent, 900, Belgium

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Calgary, Alberta, T2N 4N2, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Kingston, Ontario, K7L 5P9, Canada

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Toronto, Ontario, M6R 1B5, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Hefei, Anhui, 230022, China

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Fuzhou, Fujian, 350014, China

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Guangzhou, Guangdong, 510060, China

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Guangzhou, Guangdong, 510080, China

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Nanning, Guangxi, 530021, China

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Wuhan, Hubei, 430030, China

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Nanjing, Jiangsu, 210002, China

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Chengdu, Sichuan, 610041, China

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Hangzhou, Zhejiang, 310016, China

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Hangzhou, Zhejiang, 310022, China

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Beijing, 100021, China

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Beijing, 100035, China

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Beijing, 100071, China

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Chongqing, 400038, China

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Guangzhou, 510515, China

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Nanjing, 210009, China

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Shanghai, 200070, China

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Amiens, 80054, France

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Bordeaux, 33075, France

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Clichy, 92118, France

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Créteil, 94010, France

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Lille, 59037, France

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Nice, 06189, France

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Paris, 75012, France

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Paris, 75651, France

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Saint-Herblain, 44805, France

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Strasbourg, 67091, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Villejuif, 94804, France

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

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Mainz, 55131, Germany

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München, 81377, Germany

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Tuen Mun, New Territories, Hong Kong, Hong Kong

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Hong Hong, Hong Kong

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Kowloon, Hong Kong

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Shatin, New Territories, Hong Kong

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Meldola, FC, 47014, Italy

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Bari, 70126, Italy

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Bologna, 40138, Italy

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Cattolica (RN), 47841, Italy

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Milan, 20122, Italy

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Milan, 20132, Italy

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Padua, 35128, Italy

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Pavia, 27100, Italy

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Ravenna, 48100, Italy

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Rimini, 47900, Italy

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Nagoya, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Kashiwa-shi, Chiba, Japan

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Kurume, Fukuoka, Japan

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Gifu, Gifu, Japan

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Sapporo, Hokkaido, Japan

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Nishinomiya, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Omura-shi, Nagasaki, Japan

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Okayama, Okayama-ken, Japan

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Osaka, Osaka, Japan

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Ōsaka-sayama, Osaka, Japan

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Izunokuni-shi, Shizuoka, Japan

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Bunkyo-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Mitaka-shi, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Lembah Pantai, Kuala Lumpur, 59100, Malaysia

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Subang Jaya, Selangor, 47500, Malaysia

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Kuala Lumpur, 50586, Malaysia

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Cebu City, Cebu, 6000, Philippines

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Cebu City, 6000, Philippines

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Davao City, Philippines

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Manila, 1000, Philippines

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Manila, 1015, Philippines

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Quezon City, 1102, Philippines

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Quezon City, 1104, Philippines

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Quezon City, Philippines

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Warsaw, 02-097, Poland

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Warsaw, 02-781, Poland

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Chelyabinsk, 454087, Russia

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Pyatigorsk, 357502, Russia

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Saint Petersburg, 194044, Russia

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Singapore, Singapore, 119074, Singapore

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Singapore, Singapore, 169610, Singapore

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Parktown, 2193, South Africa

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Goyang-si, Gyeonggi-do, 411-769, South Korea

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Jeonju, Jeollabuk-do, 561-712, South Korea

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Hwasun-gun, Jeollanam-do, 519-809, South Korea

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Busan, 614-735, South Korea

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Daegu, 700-712, South Korea

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Daegu, 705-718, South Korea

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Incheon, 405-760, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Seoul, 152-703, South Korea

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Palma de Mallorca, Balearic Islands, 07198, Spain

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Sabadell, Barcelona, 08208, Spain

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Santander, Cantabria, 39008, Spain

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El Palmar, Murcia, 30120, Spain

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Seville, Sevilla, 41013, Spain

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Linköping, 581 85, Sweden

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Pu-Tz City, Chai-Yi, 613, Taiwan

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Kwei-Shan, Taoyuan, 333, Taiwan

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Changhua, 500, Taiwan

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Kaohsiung City, 807, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 404, Taiwan

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Taichung, 407, Taiwan

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Tainan, 704, Taiwan

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Tainan, 736, Taiwan

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Taipei, 110, Taiwan

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Taipei, 112, Taiwan

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Bangkok Noi, Bangkok, 10700, Thailand

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Ptumwan, Bangkok, 10330, Thailand

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Amphoe Mueang, Chiang Mai, 50200, Thailand

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Ankara, 06100, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Cambridge, Cambridgeshire, CR2 0QQ, United Kingdom

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London, W12 0NN, United Kingdom

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London, W12 OHS, United Kingdom

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Related Publications (3)

• Abuhelwa AY, Badaoui S, Yuen HY, McKinnon RA, Ruanglertboon W, Shankaran K, Tuteja A, Sorich MJ, Hopkins AM. A clinical scoring tool validated with machine learning for predicting severe hand-foot syndrome from sorafenib in hepatocellular carcinoma. Cancer Chemother Pharmacol. 2022 Apr;89(4):479-485. doi: 10.1007/s00280-022-04411-9. Epub 2022 Feb 28.

  PMID: 35226112 DERIVED

• Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.

  PMID: 24081937 DERIVED

• Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovacs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.

  PMID: 20203173 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sunitinib; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Limitations and Caveats

Study terminated early due to futility. Subsequently, EQ-5D data were not collected or analyzed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 14, 2013
• Results First Posted: January 14, 2013

Record last verified: 2012-12

Locations

TU (2); ES (5); ZA (1); CN (17); JP (19); TH (3); PL (2); AU (5); PH (8); TW (11); GB (3); DE (4); US (35); BE (3); FR (13); IT (10); MY (3); KR (12); HK (4); SE (1); CA (5); RU (3); SG (2)