Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

NCT00673049 | Terminated Phase 3 Results DMC

• 1 other identifier: A4021018
• Study Type: interventional
• Target: 583
• Locations: 27 countries
• Sites: 175

Brief Summary

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Conditions

Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Adenosquamous Cell

Keywords

IGR-1R; Non small cell lung cancer; CP-751; 871; Figitumumab

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.

  Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months

Secondary Outcomes (9)

• Progression Free Survival (PFS)

  Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months

• Percentage of Participants With Objective Response

  Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months

• Maximum Observed Plasma Concentration (Cmax) for Figitumumab

  Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group

• Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab

  Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group

• Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)

  Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group

Study Arms (2)

Arm A

EXPERIMENTAL

The CP 751,871 treatment in combination with erlotinib will be given in three week cycles. CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

Drug: CP 751,871 (Figitumumab); Drug: Erlotinib

Arm B

ACTIVE COMPARATOR

Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)

Drug: Erlotinib

Interventions

CP 751,871 (Figitumumab) DRUG

CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

Arm A

Erlotinib DRUG

Erlotinib (one tablet of 150 mg/day PO).

Arm A

Eligibility Criteria

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

You may qualify if:

• Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

You may not qualify if:

• Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
• Prior Erlotinib therapy.
• Prior anti IGF IR based investigational therapy.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (175)

Pfizer Investigational Site

Fort Smith, Arkansas, 72903, United States

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Hot Springs, Arkansas, 71913, United States

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Lakeport, California, 95453, United States

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Orange, California, 92868-3298, United States

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Orange, California, 92868, United States

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Petaluma, California, 94954, United States

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Santa Rosa, California, 95403, United States

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Thousand Oaks, California, 91360, United States

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Westlake Valley, California, 91360, United States

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Denver, Colorado, 80205, United States

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Lafayette, Colorado, 80026, United States

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Hollywood, Florida, 33021, United States

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Lake City, Florida, 32024, United States

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Lake City, Florida, 32055, United States

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Pembroke Pines, Florida, 33028, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30322, United States

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Atlanta, Georgia, 30342, United States

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Conyers, Georgia, 30094, United States

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Cumming, Georgia, 30041, United States

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Decatur, Georgia, 30033, United States

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Duluth, Georgia, 30096, United States

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Lake Spivey, Georgia, 30236, United States

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Lawrenceville, Georgia, 30046, United States

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Snellville, Georgia, 30078, United States

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Bloomington, Illinois, 61701, United States

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Peoria, Illinois, 61615, United States

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Beech Grove, Indiana, 46107, United States

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Indianapolis, Indiana, 46237, United States

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Indianapolis, Indiana, 46260, United States

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Cedar Rapids, Iowa, 52402, United States

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Waterloo, Iowa, 50701, United States

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Louisville, Kentucky, 40207, United States

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Bethesda, Maryland, 20817, United States

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New Albany, Mississippi, 38652, United States

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Billings, Montana, 59102, United States

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Butte, Montana, 59701, United States

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Lebanon, New Hampshire, 03756, United States

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Manchester, New Hampshire, 03102, United States

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Amherst, New York, 14221, United States

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Buffalo, New York, 14263, United States

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Lake Success, New York, 11042, United States

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Manhasset, New York, 11030, United States

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New Hyde Park, New York, 11040, United States

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The Bronx, New York, 10461, United States

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The Bronx, New York, 10467, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43221, United States

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Norman, Oklahoma, 73071, United States

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Oklahoma City, Oklahoma, 73102, United States

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Oklahoma City, Oklahoma, 73109, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74133, United States

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Tulsa, Oklahoma, 74136, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Germantown, Tennessee, 38138, United States

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San Antonio, Texas, 78229, United States

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Charlottesville, Virginia, 22908-0334, United States

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Charlottesville, Virginia, 22908-0716, United States

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Gloucester, Virginia, 23601, United States

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Glouster, Virginia, 23061, United States

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Newport News, Virginia, 23601, United States

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Williamsburg, Virginia, 23185, United States

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Wenatchee, Washington, 98801, United States

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Wheeling, West Virginia, 26003-6300, United States

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Cody, Wyoming, 82414, United States

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Brasschaat, 2930, Belgium

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Mons, 7000, Belgium

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Rio de Janeiro, Rio de Janeiro, 20230 -130, Brazil

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Rio de Janeiro, Rio de Janeiro, 20231 -050, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Higienópolis, Sao Paulo/ Brazil, 01224-010, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 01219-000, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 01224-010, Brazil

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Sofia, Bulgaria, 1756, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1527, Bulgaria

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Varna, 9000, Bulgaria

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Independencia, Santiago, RM, 8380455, Chile

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Kutná Hora, 284 01, Czechia

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Nová Ves pod Pleší, 26204, Czechia

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Prague, 180 81, Czechia

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Tábor, 390 03, Czechia

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Rennes, Cedex 9, 35033, France

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Brest, 29609, France

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La Tronche, 38700, France

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Lille, 59020 Cedex, France

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Marseille, 13009, France

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Marseille, 13915, France

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Saint Pierre La Réunion Cedex, 97448, France

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Saint-Priest-en-Jarez, 42277, France

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Villejuif, 94805, France

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Heraklion, Crete, 71110, Greece

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Larissa, 41110, Greece

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Budapest, 1525, Hungary

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Mátraháza, H-3233, Hungary

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Székesfehérvár, 8000, Hungary

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Jakarta, DKI Jakarta, 13230, Indonesia

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Surabaya, East Java, 60286, Indonesia

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Cork, Ireland

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Dublin, 8, Ireland

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Dublin, Ireland

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Avellino, 83100, Italy

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Aviano (PN), 33081, Italy

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Cattolica (RN), 47841, Italy

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Modena, 41100, Italy

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Orbassano (TO), 10043, Italy

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Padua, 35128, Italy

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Rimini, 47900, Italy

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Roma, 00157, Italy

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Riga, LV 1002, Latvia

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Riga, LV 1079, Latvia

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Bydgoszcz, 85-796, Poland

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Gdansk, 80-952, Poland

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Krakow, 31-108, Poland

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Krakow, 31-215, Poland

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Lublin, 20-954, Poland

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Olsztyn, 10-357, Poland

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Olsztyn, 10-513, Poland

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Rybnik, 44-200, Poland

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Wodzislaw Sl., 44-300, Poland

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Ponce, PR, 00716, Puerto Rico

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Cluj-Napoca, Cluj, 400015, Romania

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Cluj-Napoca, 400015, Romania

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Iași, 700106, Romania

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Krasnodar, 350040, Russia

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Moscow, 115478, Russia

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Moscow, 143423, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 198255, Russia

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Sochi, 354057, Russia

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Belgrade, 11000, Serbia

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Kamenitz, 21204, Serbia

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Ljubljana, 1000, Slovenia

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Bloemfontein, 9301, South Africa

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Cape Town, 7925, South Africa

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Gyeonggi-do, 410-769, South Korea

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Seoul, 120-752, South Korea

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Seoul, 138-736, South Korea

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Elche, Alicante, 03203, Spain

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Barcelona, Barcelona, 08025, Spain

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L'Hospitalet de Llobregat, Barcelona, 08097, Spain

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Manresa, Barcelona, 08243, Spain

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Sabadell, Barcelona, 08208, Spain

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Girona, Girona, 17007, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28033, Spain

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Madrid, Madrid, 28041, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Seville, Sevilla, 41009, Spain

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Seville, Sevilla, 41013, Spain

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Basel, CH-4031, Switzerland

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Basel, CH-4058, Switzerland

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Ch-4101 Bruderholz, Switzerland

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Chur, 7000, Switzerland

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Liestal, CH-4410, Switzerland

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Taichung, 404, Taiwan

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Taipei, 112, Taiwan

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Taoyuan, 333, Taiwan

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Dnipropetrovsk, 49102, Ukraine

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Donetsk, 83092, Ukraine

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Kharkiv, 61070, Ukraine

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Kyiv, 03115, Ukraine

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Sumy, 40005, Ukraine

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Sutton, Surrey, SM2 5PT, United Kingdom

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London, SW3 6JJ, United Kingdom

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London, W6 8RF, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Related Publications (1)

• Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.

  PMID: 25395283 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Large Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma

Interventions

figitumumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: May 5, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2012
• Last Updated: July 24, 2013
• Results First Posted: July 24, 2013

Record last verified: 2013-07

Locations

KR (3); US (69); SL (1); BU (4); BE (2); HU (3); CA (2); FR (9); BR (8); CZ (4); PL (9); LA (2); RU (6); PR (1); CL (1); ID (2); GR (2); IT (8); TW (3); UA (5); GB (4); CH (5); SE (2); ZA (2); IE (3); ES (12); RO (3)