Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00596830
• Other study ID #: A4021016
• Status: Terminated
• Phase: Phase 3
• First received: January 3, 2008
• Last updated: December 11, 2013
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

Description:

The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 681
• Est. completion date: September 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.

• Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.

• No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.

• Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.

• ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

• Patients with symptomatic central nervous system (CNS) metastases are not permitted.

• Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.

• Patients with other active cancer types are not permitted.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• CP-751,871 (Figitumumab)
CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
• Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
• Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
• Carboplatin
Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
• Paclitaxel
Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Albury	New South Wales
Australia	Pfizer Investigational Site	Geelong	Victoria
Australia	Pfizer Investigational Site	Port Macquarie	New South Wales
Australia	Pfizer Investigational Site	Wodonga	Victoria
Austria	Pfizer Investigational Site	Linz
Austria	Pfizer Investigational Site	Wien
Brazil	Pfizer Investigational Site	Higienopolis	Sao Paulo/ Brazil
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Varna
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Levis	Quebec
Czech Republic	Pfizer Investigational Site	Nova Ves pod Plesi
Czech Republic	Pfizer Investigational Site	Praha 8
Czech Republic	Pfizer Investigational Site	Pribram I
Czech Republic	Pfizer Investigational Site	Pribram V
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Pori
France	Pfizer Investigational Site	Caen Cedex
France	Pfizer Investigational Site	Caen Cedex 05
France	Pfizer Investigational Site	Clermond-Ferrand Cedex 01
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Lyon Cedex 04
France	Pfizer Investigational Site	Nantes Cedex 2
France	Pfizer Investigational Site	Rennes Cedex 9
France	Pfizer Investigational Site	Saint Herblain Cedex
France	Pfizer Investigational Site	Saint Pierre la Réunion Cedex
Germany	Pfizer Investigational Site	Grosshansdorf
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Oldenburg
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki	Pylaia
Hong Kong	Pfizer Investigational Site	Kowloon
Hong Kong	Pfizer Investigational Site	Shatin, New Territories
Hong Kong	Pfizer Investigational Site	Tuen Mun
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Deszk
Hungary	Pfizer Investigational Site	Szekesfehervar
Hungary	Pfizer Investigational Site	Szombathely
Hungary	Pfizer Investigational Site	Torokbalint
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Mumbai	Maharashtra
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	Navrangpura / Ahmedabad	Gujarat
India	Pfizer Investigational Site	New Delhi
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Orbassano (TO)
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Roma
Japan	Pfizer Investigational Site	Akashi	Hyogo
Japan	Pfizer Investigational Site	Chuo-Ku	Tokyo
Japan	Pfizer Investigational Site	Gifu-shi	Gifu
Japan	Pfizer Investigational Site	Kashiwa	Chiba
Japan	Pfizer Investigational Site	Matsuyama-shi	Ehime
Japan	Pfizer Investigational Site	Osaka-city	Osaka
Japan	Pfizer Investigational Site	Osakasayama-shi	Osaka
Japan	Pfizer Investigational Site	Sakai-shi	Osaka-fu
Japan	Pfizer Investigational Site	Sapporo-shi	Hokkaido
Japan	Pfizer Investigational Site	Tokyo
Japan	Pfizer Investigational Site	Yokohama-city	Kanagawa
Korea, Republic of	Pfizer Investigational Site	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Krakow
Poland	Pfizer Investigational Site	Siedlce
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Wroclaw
Puerto Rico	Pfizer Investigational Site	Ponce
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	Samara
Russian Federation	Pfizer Investigational Site	Sochi
Russian Federation	Pfizer Investigational Site	St-Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Slovakia	Pfizer Investigational Site	Nitra-Zobor
Slovakia	Pfizer Investigational Site	Nove Zamky
Slovakia	Pfizer Investigational Site	Poprad
Spain	Pfizer Investigational Site	Cordoba
Spain	Pfizer Investigational Site	L'hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Pamplona	Navarra
Spain	Pfizer Investigational Site	Santander	Cantabria
Spain	Pfizer Investigational Site	Valencia
Switzerland	Pfizer Investigational Site	Fribourg
Switzerland	Pfizer Investigational Site	Zuerich
Taiwan	Pfizer Investigational Site	Niao Sung Hsiang	Kaohsiung Hsien
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Turkey	Pfizer Investigational Site	Adana
Turkey	Pfizer Investigational Site	Ankara
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lviv
Ukraine	Pfizer Investigational Site	Sumy
United States	Pfizer Investigational Site	Alpharetta	Georgia
United States	Pfizer Investigational Site	Arlington	Virginia
United States	Pfizer Investigational Site	Arlington Heights	Illinois
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Aurora	Illinois
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Avon	Indiana
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bartlett	Tennessee
United States	Pfizer Investigational Site	Beech Grove	Indiana
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Bountiful	Utah
United States	Pfizer Investigational Site	Burlington	North Carolina
United States	Pfizer Investigational Site	Canton	Ohio
United States	Pfizer Investigational Site	Cedar Rapids	Iowa
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Christiansburg	Virginia
United States	Pfizer Investigational Site	Clairton	Pennsylvania
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Coeur d' Alene	Idaho
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Columbus	Mississippi
United States	Pfizer Investigational Site	Conyers	Georgia
United States	Pfizer Investigational Site	Corinth	Mississippi
United States	Pfizer Investigational Site	Cumming	Georgia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Dover	Ohio
United States	Pfizer Investigational Site	Duluth	Georgia
United States	Pfizer Investigational Site	Elk Grove Village	Illinois
United States	Pfizer Investigational Site	Fairfax	Virginia
United States	Pfizer Investigational Site	Farmington Hills	Michigan
United States	Pfizer Investigational Site	Florence	Alabama
United States	Pfizer Investigational Site	Fort Sam Houston	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Gainesville	Virginia
United States	Pfizer Investigational Site	Galesburg	Illinois
United States	Pfizer Investigational Site	Grapevine	Texas
United States	Pfizer Investigational Site	Greensburg	Pennsylvania
United States	Pfizer Investigational Site	Hobart	Indiana
United States	Pfizer Investigational Site	Hobart	Indiana
United States	Pfizer Investigational Site	Hot Springs	Arkansas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Hudson	Florida
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Irving	Texas
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Lake City	Florida
United States	Pfizer Investigational Site	Lake City	Florida
United States	Pfizer Investigational Site	Lake Spivey	Georgia
United States	Pfizer Investigational Site	Lake Success	New York
United States	Pfizer Investigational Site	Lakewood	Colorado
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lawrence	Massachusetts
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Layton	Utah
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Lee's Summit	Missouri
United States	Pfizer Investigational Site	Leesburg	Virginia
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Littleton	Colorado
United States	Pfizer Investigational Site	Lone Tree	Colorado
United States	Pfizer Investigational Site	Longmont	Colorado
United States	Pfizer Investigational Site	Longview	Texas
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Macon	Georgia
United States	Pfizer Investigational Site	Manchester	New Hampshire
United States	Pfizer Investigational Site	Manhasset	New York
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Maryville	Tennessee
United States	Pfizer Investigational Site	McKeesport	Pennsylvania
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miramar Beach	Florida
United States	Pfizer Investigational Site	Mooresville	Indiana
United States	Pfizer Investigational Site	Mooresville	Indiana
United States	Pfizer Investigational Site	Munster	Indiana
United States	Pfizer Investigational Site	Murray	Utah
United States	Pfizer Investigational Site	Muscle Shoals	Alabama
United States	Pfizer Investigational Site	New Hyde Park	New York
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	Norwalk	Connecticut
United States	Pfizer Investigational Site	Norwich	Connecticut
United States	Pfizer Investigational Site	Oneida	New York
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Oswego	New York
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Oxford	Mississippi
United States	Pfizer Investigational Site	Parker	Colorado
United States	Pfizer Investigational Site	Pensacola	Florida
United States	Pfizer Investigational Site	Pensacola	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Port St. Lucie	Florida
United States	Pfizer Investigational Site	Provo	Utah
United States	Pfizer Investigational Site	Quincy	Massachusetts
United States	Pfizer Investigational Site	Radnor	Pennsylvania
United States	Pfizer Investigational Site	Roanoke	Virginia
United States	Pfizer Investigational Site	Round Rock	Texas
United States	Pfizer Investigational Site	Round Rock	Texas
United States	Pfizer Investigational Site	Salem	Virginia
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Marcos	Texas
United States	Pfizer Investigational Site	Sayre	Pennsylvania
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Shawnee Mission	Kansas
United States	Pfizer Investigational Site	Snellville	Georgia
United States	Pfizer Investigational Site	Southaven	Mississippi
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Spokane Valley	Washington
United States	Pfizer Investigational Site	Spring Hill	Florida
United States	Pfizer Investigational Site	St. Joseph	Michigan
United States	Pfizer Investigational Site	St. Louis Park	Minnesota
United States	Pfizer Investigational Site	Stoneham	Massachusetts
United States	Pfizer Investigational Site	Sumter	South Carolina
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Thornton	Colorado
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Tupelo	Mississippi
United States	Pfizer Investigational Site	Tyler	Texas
United States	Pfizer Investigational Site	West Valley City	Utah
United States	Pfizer Investigational Site	Wexford	Pennsylvania
United States	Pfizer Investigational Site	Weymouth	Massachusetts
United States	Pfizer Investigational Site	Winchester	Virginia
United States	Pfizer Investigational Site	Winfield	Illinois
United States	Pfizer Investigational Site	Woodbridge	Virginia
United States	Pfizer Investigational Site	Worcester	Massachusetts
United States	Pfizer Investigational Site	Wytheville	Virginia
United States	Pfizer Investigational Site	Yorkville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  Czech Republic,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Russian Federation,  Slovakia,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.	Baseline until death, assessed monthly after end of treatment, up to 30 months	No
Secondary	Progression-Free Survival (PFS)	PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).	At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.	No
Secondary	Percentage of Participants With Objective Response (OR)	Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as =30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.	At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months	No
Secondary	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)	EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.	Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months	No
Secondary	European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.	Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months	No
Secondary	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.	Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for Figitumumab		Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab		Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose	No
Secondary	Number of Participants With Total Anti-drug Antibodies (ADA)	ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.	Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose	No
Secondary	Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels		Cycles 1 and 4 (predose) and at end of treatment	No

External Links

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