CP-751,871 Treatment For Patients With Multiple Myeloma | NCT01536145

CP-751,871 Treatment For Patients With Multiple Myeloma | NCT01536145 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Single agent CP-751,871	Experimental	dose escalation design	Drug: CP-751,871

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CP-751,871	Drug	CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability	Single agent CP-751,871

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD)	The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants	Baseline up to Cycle 1 (Week 4 or Week 8)

Secondary Outcomes

Measure	Description	Time Frame
Single Dose End-of-infusion Concentration (Cinf) for CP-751,871		1 hour postdose in Cycle 1
Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871		Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Phoenix	Arizona	85054	United States
Pfizer Investigational Site

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 0.025 mg/kg	CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG001	CP-751,871 0.05 mg/kg	CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG002	CP-751,871 0.1 mg/kg	CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG003	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG004	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG005	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG006	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG007	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
FG008	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
FG009	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
FG010	CP-751,871 20 mg/kg	CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects FG0014 subjects FG0023 subjects FG0033 subjects FG0044 subjects FG0053 subjects FG0063 subjects FG0074 subjects FG0083 subjects FG0097 subjects FG01010 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG004
NOT COMPLETED		FG0003 subjects FG0014 subjects FG0022 subjects FG0032 subjects FG004

Type	Comment	Reasons
Progressive disease		FG0003 subjects FG0014 subjects FG0021 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	CP-751,871	CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

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

Maximum Tolerated Dose (MTD)

The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants

All participants who received at least 1 dose of study drug CP-751,871.

Posted

Number

mg/kg

Baseline up to Cycle 1 (Week 4 or Week 8)

ID	Title	Description
OG000	CP-751,871 0.025-20 mg/kg	CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

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	CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE v3.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ABDOMINAL PAIN	General disorders	CTCAE v3.0	Non-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
D009101	Multiple Myeloma

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

ID	Term
C525021	figitumumab

Secondary

Single Dose End-of-infusion Concentration (Cinf) for CP-751,871

All participants treated who had at least 1 concentration.

Posted

Mean

Standard Deviation

milligram/liter (mg/L)

1 hour postdose in Cycle 1

ID	Title	Description
OG000	CP-751,871 0.025 mg/kg	CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.05 mg/kg	CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.1 mg/kg	CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG007	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG008	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG009	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
OG010	CP-751,871 20 mg/kg	CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0002 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000± NANumber of participants analyzed was less than 3, thus standard deviation was not calculated. OG0010.381± 0.448 OG0025.32± 6.85

Secondary

Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871

All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.

Posted

Mean

Standard Deviation

milligram•hour/liter (mg•hr/L)

Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

ID	Title	Description
OG000	CP-751,871 0.1 mg/kg	CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG007	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
OG008	CP-751,871 20 mg/kg	CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0002 OG0013 OG0024 OG003

Title

Denominators

Categories

Title	Measurements
	OG000101± NANumber of participants analyzed was less than 3, thus standard deviation was not calculated. OG001202± 29.2 OG0021016± 583

Secondary

Single Dose Volume of Distribution (Vz) for CP-751,871

All participants treated who had at least 1 of the PK parameters of primary interest.

Posted

Mean

Standard Deviation

milliliter/kilogram (mL/kg )

Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

ID	Title	Description
OG000	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0003 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00046.3± 12.2 OG00163.3± 26.4 OG00264.5± 29.7 OG003

Secondary

Single Dose Plasma Decay Half-life (t1/2) for CP-751,871

All participants treated who had at least 1 of the PK parameters of primary interest.

Posted

Mean

Standard Deviation

days

Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

ID	Title	Description
OG000	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0003 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.70± 0.631 OG0014.63± 2.88 OG0024.10± 0.0566 OG003

Secondary

Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871

All participants treated who had at least 1 of the PK parameters of primary interest.

Posted

Mean

Standard Deviation

mg•hr/L

Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

ID	Title	Description
OG000	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0003 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG000249± 42.5 OG0011121± 645 OG0022191± 1396 OG003

Secondary

Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871

All participants treated who had at least 1 of the PK parameters of primary interest.

Posted

Mean

Standard Deviation

mL/kg

Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

ID	Title	Description
OG000	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0003 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00046.0± 11.9 OG00165.9± 24.7 OG00272.6± 21.1 OG003

Secondary

Single Dose Systemic Clearance (CL) for CP-751,871

All participants treated who had at least 1 of the PK parameters of primary interest.

Posted

Mean

Standard Deviation

milliliter/day/kilogram (mL/day/kg)

Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose

ID	Title	Description
OG000	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0003 OG0014 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG00019.7± 3.65 OG00111.9± 8.75 OG00210.9± 5.09 OG003

Secondary

Multiple Dose Cinf for CP-751,871

Multiple dose Cinf data were listed for individual subjects, however were not summarized by descriptive statistics.

Posted

1 hour postdose in Cycles 2 up to 16

ID	Title	Description
OG000	CP-751,871 0.025 mg/kg	CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.05 mg/kg	CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.1 mg/kg	CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG007	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG008	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG009	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
OG010	CP-751,871 20 mg/kg	CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871

Multiple dose Cmin data were listed for individual subjects, however were not summarized by descriptive statistics.

Posted

0 hour (predose) in Cycles 2 up to 16

ID	Title	Description
OG000	CP-751,871 0.025 mg/kg	CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.05 mg/kg	CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.1 mg/kg	CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG007	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG008	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG009	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
OG010	CP-751,871 20 mg/kg	CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Pharmacodynamic-based Dose

The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression

Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.

Posted

Cycle 1 (Week 4 or Week 8)

ID	Title	Description
OG000	CP-751,871 0.025-20 mg/kg	CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0000

Secondary

Human Anti-human Antibody (HAHA) Response to CP-751,871

All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.

Posted

Number

30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg

ID	Title	Description
OG000	CP-751,871 0.025-20 mg/kg	CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG00028

Title

Denominators

Categories

Title	Measurements
	OG000NANone of the analyzed samples were positive for anti-CP-751,871 antibodies, as suggested by a titer measurement of less than 3.32.

Secondary

Percentage of Participants With Objective Response (OR)

Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).

All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.

Posted

Number

percentage of participants

Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)

ID	Title	Description
OG000	CP-751,871 0.025 mg/kg	CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.05 mg/kg	CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.1 mg/kg	CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG007	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG008	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG009	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
OG010	CP-751,871 20 mg/kg	CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

Time to Disease Progression

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease [PD])

A substantial number of participants were not followed-up prior to disease progression, therefore time to disease progression was not estimated.

Posted

Baseline up to end of treatment

ID	Title	Description
OG000	CP-751,871 0.025 mg/kg	CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG001	CP-751,871 0.05 mg/kg	CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG002	CP-751,871 0.1 mg/kg	CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG003	CP-751,871 0.2 mg/kg	CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG004	CP-751,871 0.4 mg/kg	CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG005	CP-751,871 0.8 mg/kg	CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG006	CP-751,871 1.5 mg/kg	CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG007	CP-751,871 3 mg/kg	CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
OG008	CP-751,871 6 mg/kg	CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
OG009	CP-751,871 10 mg/kg	CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
OG010	CP-751,871 20 mg/kg	CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003