Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

NCT00676650 | Terminated Phase 3 Results DMC

• 1 other identifier: A6181120
• Study Type: interventional
• Target: 873
• Locations: 22 countries
• Sites: 205

Brief Summary

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Conditions

Prostatic Neoplasms

Keywords

Docetaxel-refractory mCRPC; Second-line treatment with sunitinib and prednisone

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus \[-\] date of randomization plus \[+\] 1) divided (/) 30.4.

  Baseline up to 32 months

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

  Baseline, every 8 weeks up to 123 weeks

• Percent of Participants With Objective Response (OR)

  Baseline, every 8 weeks up to 123 weeks

• Duration of Response (DR)

  Baseline, every 8 weeks up to 123 weeks

• Change From Baseline in Pain Severity

  Day 1 through Day 7 every 28 days (every cycle) up to 29 months

• Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)

  Baseline, every 4 weeks up to 123 weeks

Study Arms (2)

A

EXPERIMENTAL

Treatment Arm A - sunitinib + prednisone

Drug: Prednisone; Drug: sunitinib

B

PLACEBO COMPARATOR

Treatment Arm B - placebo + prednisone

Drug: Placebo; Drug: Prednisone

Interventions

Prednisone DRUG

5 mg BID, oral

Also known as: Deltasone

A

sunitinib DRUG

37.5 mg/day, oral, administered on a continuous daily dosing regimen

Also known as: Sutent, SU011248

A

Placebo DRUG

37.5 mg/day, oral, administered on a continuous daily dosing regimen

B

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
• Progressive disease based on PSA progression, RECIST, or positive bone scan.
• ECOG 0 or 1.

You may not qualify if:

• Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
• Chemotherapy within 3 weeks.
• Impending complications from bone metastases.
• Ongoing urinary obstruction.
• Cardiac dysfunction, QTc \>470 msec.
• CNS involvement.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (205)

Pfizer Investigational Site

Decatur, Alabama, 35601, United States

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Huntsville, Alabama, 35801, United States

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Huntsville, Alabama, 35805, United States

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Anaheim, California, 92801, United States

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Encinitas, California, 92024, United States

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Glendale, California, 91206, United States

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La Jolla, California, 92037, United States

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Los Angeles, California, 90033, United States

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Modesto, California, 95355, United States

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Thousand Oaks, California, 91360, United States

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Thousands Oaks, California, 91360, United States

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Vista, California, 92083, United States

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Westlake Village, California, 91361, United States

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Denver, Colorado, 80205, United States

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Lafayette, Colorado, 80025, United States

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Gainesville, Florida, 32605, United States

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Orlando, Florida, 32806, United States

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Winter Park, Florida, 32789, United States

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Arlington Heights, Illinois, 60005, United States

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Niles, Illinois, 60714, United States

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Winfield, Illinois, 60190, United States

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Zion, Illinois, 60099, United States

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Carmel, Indiana, 46032, United States

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Fishers, Indiana, 46037, United States

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Greenfield, Indiana, 46140, United States

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Indianapolis, Indiana, 46219, United States

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Indianapolis, Indiana, 46227, United States

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Lafayette, Indiana, 47905, United States

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Louisville, Kentucky, 40207, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02114, United States

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Danvers, Massachusetts, 01923, United States

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Minneapolis, Minnesota, 55455, United States

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Saint Cloud, Minnesota, 56303-5000, United States

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Corinth, Mississippi, 38834, United States

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Southaven, Mississippi, 38671, United States

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Lincoln, Nebraska, 68506, United States

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Omaha, Nebraska, 68114, United States

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Henderson, Nevada, 89052, United States

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Henderson, Nevada, 89074, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89148, United States

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Las Vegas, Nevada, 89169, United States

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Sewell, New Jersey, 08080, United States

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New York, New York, 10032, United States

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The Bronx, New York, 10461, United States

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The Bronx, New York, 10467-2401, United States

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Cary, North Carolina, 27518, United States

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Durham, North Carolina, 27710, United States

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Kernersville, North Carolina, 27284, United States

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Lexington, North Carolina, 27295, United States

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Mount Airy, North Carolina, 27030, United States

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North Wilkesboro, North Carolina, 28659, United States

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Raleigh, North Carolina, 27607, United States

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Raleigh, North Carolina, 27614, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Cleveland, Ohio, 44106, United States

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Mayfield Heights, Ohio, 44124, United States

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Mentor, Ohio, 44060, United States

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Orange, Ohio, 44122, United States

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Westlake, Ohio, 44145, United States

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Eugene, Oregon, 97401, United States

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Springfield, Oregon, 97477, United States

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Clairton, Pennsylvania, 15025, United States

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Greensburg, Pennsylvania, 15601, United States

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Johnstown, Pennsylvania, 15901, United States

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Kingston, Pennsylvania, 18704, United States

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Lancaster, Pennsylvania, 17604, United States

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Pittsburgh, Pennsylvania, 15215, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Pittsburgh, Pennsylvania, 15237, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Uniontown, Pennsylvania, 15401, United States

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Wexford, Pennsylvania, 15090, United States

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Brighton, Tennessee, 38011, United States

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Memphis, Tennessee, 38104, United States

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Memphis, Tennessee, 38120, United States

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Arlington, Texas, 76014, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76177, United States

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Houston, Texas, 77030, United States

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Webster, Texas, 77598, United States

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Everett, Washington, 98201, United States

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Monroe, Washington, 98272, United States

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Seattle, Washington, 98101, United States

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Milwaukee, Wisconsin, 53226, United States

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Port Macquarie, New South Wales, 2444, Australia

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Wahroong, New South Wales, 2076, Australia

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Westmead, New South Wales, 2145, Australia

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Wodonga, Victoria, 3690, Australia

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Brussels, 1000, Belgium

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Liège, 4000, Belgium

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Mons, 7000, Belgium

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Namur, 5000, Belgium

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Wilrijk, 2610, Belgium

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Salvador, Estado de Bahia, 40170-110, Brazil

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Belo Horizonte, Minas Gerais, 30150-281, Brazil

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Rio de Janeiro, Rio de Janeiro, 22260-020, Brazil

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Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil

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Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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Kelowna, British Columbia, V1Y 5L3, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Wuhan, Hubei, 430030, China

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Beijing, 100036, China

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Chongqing, 400038, China

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Shanghai, 200032, China

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Shanghai, 200433, China

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Brno, 625 00, Czechia

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Olomouc, 775 20, Czechia

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Ústí nad Labem, 40113, Czechia

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Herlev, 2730, Denmark

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Koebenhavn Oe, 2100, Denmark

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Odense C, 5000, Denmark

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Vejle, 7100, Denmark

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Helsinki, 00290, Finland

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Tampere, 33520, Finland

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Besançon, 25030, France

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Bordeaux, 33076, France

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Clermont-Ferrand, 63011, France

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Lille, 59000, France

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Lyon, 69008, France

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Paris, 75908, France

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Poitiers, 86021, France

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Rennes, 35042, France

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Rouen, 76031, France

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Saint-Grégoire, 35760, France

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Tours, 37044, France

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Berlin, 10719, Germany

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Homburg/Saar, 66421, Germany

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Kempen, 47906, Germany

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Leipzig, 04109, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Kfar Saba, Israel

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Petah Tikva, 49100, Israel

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Tel Litwinsky, 52621, Israel

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Ẕerifin, 70300, Israel

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Meldola, FC, 47014, Italy

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Lido Di Camaiore (LU), 55043, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Pavia, 27100, Italy

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Pisa, 56100, Italy

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Potenza, 85100, Italy

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Roma, 00135, Italy

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Roma, 00152, Italy

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Arequipa, Arequipa, Peru

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Lima, Lima Province, Lima 27, Peru

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Bellavista, Provincia Constitucional del Callao, Callao 02, Peru

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Gdansk, 80-952, Poland

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Kielce, 25-734, Poland

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Warsaw, 02-507, Poland

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Warsaw, 02-781, Poland

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Porto, 4200-072, Portugal

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Porto, 4200-319, Portugal

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Setúbal, 2910-446, Portugal

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Bratislava, 833 10, Slovakia

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Bratislava, 85105, Slovakia

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Martin, 036 01, Slovakia

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Prešov, 080 01, Slovakia

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Žilina, 012 07, Slovakia

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Goyang-si, Gyeonggi-do, 410-769, South Korea

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Seongnam, Gyunggido, 463-802, 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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A Coruña, A Coruña, 15006, Spain

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Elche, Alicante, 03203, Spain

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Barcelona, Barcelona, 08035, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Girona, Gerona, 17007, Spain

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Guadalajara, Guadalajara, 19002, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28041, Spain

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Madrid, Madrid, 28050, Spain

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Pamplona, Navarre, 31008, Spain

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Seville, Sevilla, 41013, Spain

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Valencia, Valencia, 46026, Spain

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Lund, 221 85, Sweden

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Malmo, 205 02, Sweden

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Stockholm, 171 76, Sweden

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Vaxjo, 351 85, Sweden

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Taichung, 407, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taoyuan District, 333, Taiwan

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Bournemouth, Dorset, BH7 7DW, United Kingdom

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Preston, Lancashire, PR2 9HT, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Bristol, BS2 8ED, United Kingdom

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Cardiff, CF14 2TL, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Glasgow, G52 3NQ, United Kingdom

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Guildford, GU2 7XX, United Kingdom

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London, SE1 9RT, United Kingdom

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Sheffield, S10 2SJ, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Related Publications (1)

• Michaelson MD, Oudard S, Ou YC, Sengelov L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullen A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.

  PMID: 24323035 DERIVED

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Prednisone; Sunitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

A complete analysis was not performed due to the sponsors early termination of the clinical trial.

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-02

Locations

BE (5); FR (11); PT (3); CZ (3); IL (4); IT (9); GB (11); DK (4); US (87); SL (5); CN (5); CA (6); DE (8); PE (3); TW (4); ES (12); PL (4); FI (2); BR (6); AU (4); SE (4); KR (5)