Study of CP-751,871 in Combination With Carboplatin and P... | NCT00603538

ID	Type	Description	Link
Japan CTPN 19-2409

Study of CP-751,871 in Combination With Carboplatin and P... | NCT00603538 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
CP-751,871	Experimental		Drug: CP-751,871 + carboplatin + paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CP-751,871 + carboplatin + paclitaxel	Drug	Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose Limiting Toxicities (DLT)	A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.	Cycle 1

Secondary Outcomes

Measure	Description	Time Frame
Maximum Observed Concentration (Cmax) of CP-751,871		Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Chuo-ku	Tokyo		Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21748299	Derived	Goto Y, Sekine I, Tanioka M, Shibata T, Tanai C, Asahina H, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Kikkawa H, Ohki E, Tamura T. Figitumumab combined with carboplatin and paclitaxel in treatment-naive Japanese patients with advanced non-small cell lung cancer. Invest New Drugs. 2012 Aug;30(4):1548-56. doi: 10.1007/s10637-011-9715-4. Epub 2011 Jul 13.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Arm/Group Information

ID	Title	Description
FG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
FG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
FG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0017 subjectsIncluding one participant who discontinued from the study prior to CP-751,871 administration. FG0026 subjects
COMPLETED		FG0003 subjects FG0013 subjects FG0024 subjects
NOT COMPLETED		FG0003 subjects FG0014 subjects FG0022 subjects

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0014 subjects FG0022 subjects
Objective progression or relapse		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Number

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose Limiting Toxicities (DLT)

A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.

DLT Evaluation Set comprised of participants who were treated with CP-751,871. One participant in the 10 mg/kg cohort who discontinued from the study due to an adverse event occurred prior to CP-751,871 administration was excluded from this analysis set.

Posted

Number

participants

Cycle 1

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypersensitivity	Immune system disorders	MedDRA12.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA12.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Pfizer ClinicalTrials.gov Call Center	Pfizer, Inc.	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

Condition Browse Module

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Intervention Browse Module

ID	Term
C525021	figitumumab
D016190	Carboplatin
D017239	Paclitaxel

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes

ECOG Performance Status

ECOG = Eastern Cooperative Oncology Group. ECOG Grade: 0: Fully active. 1: Ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of all selfcare. 3: Capable of limited selfcare, confined to bed or chair more than 50% of waking hours. 4: Completely disabled, no selfcare, totally confined to bed or chair. 5: Dead.

Number

participants

Title

Denominators

Categories

Score 0

Title	Measurements
	BG0005 BG0017 BG0024 BG00316

Score 1

Title	Measurements
	BG0001 BG0010 BG0022 BG003

Secondary

Maximum Observed Concentration (Cmax) of CP-751,871

The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.

n = the number of participants analyzed

Posted

Mean

Standard Deviation

mg/L

Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0006 OG0016 OG0026

Title

Denominators

Categories

Cycle 1 (n=6,6,6)

Title	Measurements
	OG000113± 16 OG001197± 33 OG002485± 59

Cycle 4 (n=4,4,5)

Secondary

Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Participants with sufficient sampling to capture the terminal disposition phase were analyzed.

Posted

Mean

Standard Deviation

hours

Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0004 OG0011 OG0024

Title

Denominators

Categories

Title	Measurements
	OG000264± 38.9 OG001NA± NAMean was not calculated because there was only 1 participant to be analyzed. OG002248± 30.1

Secondary

Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)

AUC(0-day22) : AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sampling for the next cycle. AUC(0-day22) was calculated using the linear/log trapezoidal method.

The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.

Posted

Mean

Standard Deviation

mg*h/L

Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0006 OG0016 OG0026

Title

Denominators

Categories

Title	Measurements
	OG00022400± 4050 OG00136700± 10400 OG00282700± 11200

Secondary

Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)

AUCtau: AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sampling for the next cycle. AUCtau was calculated using the linear/log trapezoidal method.

The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.

Posted

Mean

Standard Deviation

mg*h/mL

Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0002 OG0012 OG0022

Title

Denominators

Categories

Title	Measurements
	OG000NA± NAMean was not calculated because there were only 2 participants who had estimable AUCtau at Cycle 4. OG001NA± NAMean was not calculated because there were only 2 participants who had estimable AUCtau at Cycle 4. OG002

Secondary

Observed Accumulation Ratio (Rac)

The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau

The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.

Posted

Mean

Standard Deviation

ratio

Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0002 OG0012 OG0022

Title

Denominators

Categories

Title	Measurements
	OG000NA± NAMean was not calculated because there were only 2 participants who had estimable Rac at Cycle 4. OG001NA± NAMean was not calculated because there were only 2 participants who had estimable Rac at Cycle 4. OG002

Secondary

Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)

IGF-1 is one of the IGF-axis related biomarkers.

Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.

Posted

Mean

Standard Deviation

ng/L

Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0006 OG0017 OG0026

Title

Denominators

Categories

Cycle 1 Day 1 (n=6,7,6)

Title	Measurements
	OG000126.2± 54.0 OG001167.7± 64.2 OG002136.8± 45.4

Cycle 1 Day 8 (n=6,6,6)

Secondary

Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)

IGF-BP3 is one of the IGF-axis related biomarkers.

Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.

Posted

Mean

Standard Deviation

mg/L

Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0006 OG0017 OG0026

Title

Denominators

Categories

Cycle 1 Day 1 (n=6,7,6)

Title	Measurements
	OG0002.38± 0.82 OG0012.26± 0.59 OG0022.55± 0.39

Cycle 1 Day 8 (n=6,6,6)

Secondary

Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.

The screening assay for anti-CP-751,871 antibodies was performed.

All participants were screened for the ADA.

Posted

Number

participants

Day 1 of Cycles 1 (predose) and 4, and end of study

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0006 OG0017 OG0026

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020

Secondary

Number of Participants With Objective Response

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

Full Analysis Set (FAS) was defined as all participants who met all of the following criteria; 1) Those who were diagnosed with NSCLC, 2) Those who received at least one dose of the study treatment, and 3) Those who had efficacy data after the start of the study treatment.

Posted

Number

participants

Baseline up to 6 cycles (1 cycle = 21 days)

ID	Title	Description
OG000	CP-751,871 6 mg/kg in Combination With Chemotherapy Agents	CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10 mg/kg in Combination With Chemotherapy Agents	CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20 mg/kg in Combination With Chemotherapy Agents	CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0006 OG0016 OG0026

Title

Denominators

Categories

Complete Response (CR)

Title	Measurements
	OG0000 OG0010 OG0020

Partial Response (PR)

Secondary

Progression-Free Survival (PFS)

PFS is the period from the registration to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Number of participants with defined event (all causality death or PD) was too few to conduct summary analysis.

Posted

Baseline up to 6 cycles (1 cycle = 21 days)

ID	Title	Description
OG000	CP-751,871 6mg/kg in Combination With Chemotherapy Agents	CP-751,871 6mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG001	CP-751,871 10mg/kg in Combination With Chemotherapy Agents	CP-751,871 10mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
OG002	CP-751,871 20mg/kg in Combination With Chemotherapy Agents	CP-751,871 20mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.

Units	Counts
Participants	OG0000 OG0010 OG0020