Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

Phase 1

Completed

• Conditions: Sarcoma, Ewing's
• Interventions: Drug: CP-751,871

• Registration Number: NCT00474760
• Lead Sponsor: Pfizer

Brief Summary

This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-17
• Primary Completion: 2011-01
• Study Completion: 2012-10
• Status Verified: 2013-10
• Results First Submitted: 2013-10-25
• Results First Submitted QC: 2013-10-25
• Last Update Submitted: 2013-10-25
• Results First Posted: 2013-12-17
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Diagnosis of Ewing's sarcoma family tumors

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Exclusion Criteria

• Concurrent treatment with any other anti tumor agents

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CP-751,871	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 150 days after the last administration of study drug	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Secondary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Plasma Decay Half-Life (t1/2) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Systemic Clearance (CL) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Plasma Decay Half-Life (t1/2) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Maximum Observed Plasma Concentration (Cmax) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Maximum Observed Plasma Concentration (Cmax) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Concentration at End of Infusion (Cendinf) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Systemic Clearance (CL) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Concentration at End of Infusion (Cendinf) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution (Vz) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Volume of Distribution (Vz) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Volume of Distribution at Steady State (Vss) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.
Volume of Distribution at Steady State (Vss) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Area under the plasma concentration time-curve from zero to the last measured concentration
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Area under the plasma concentration time-curve from zero to the last measured concentration
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Human Anti-human Antibodies (HAHA) Levels	30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)	HAHA were indicators of immunogenicity to figitumumab.
Number of Circulating Tumor Cells (CTCs)	30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort	Quantification of CTCs using an automated microscope system
Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs	30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort	Quantification of IGF-IR positive CTCs using an automated microscope system

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Sutton, Surrey, United Kingdom