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

Primary Purpose

Sarcoma, Ewing's

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CP-751,871
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Ewing's

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

  • Concurrent treatment with any other anti tumor agents

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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

Maximum Observed Plasma Concentration (Cmax) in Cycle 1
Maximum Observed Plasma Concentration (Cmax) in Cycle 4
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4
Plasma Decay Half-Life (t1/2) in Cycle 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Plasma Decay Half-Life (t1/2) in Cycle 4
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
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4
Systemic Clearance (CL) in Cycle 1
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Systemic Clearance (CL) in Cycle 4
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 1
Concentration at End of Infusion (Cendinf) in Cycle 4
Volume of Distribution (Vz) in Cycle 1
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
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
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
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
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
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
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
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4
Human Anti-human Antibodies (HAHA) Levels
HAHA were indicators of immunogenicity to figitumumab.
Number of Circulating Tumor Cells (CTCs)
Quantification of CTCs using an automated microscope system
Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
Quantification of IGF-IR positive CTCs using an automated microscope system

Full Information

First Posted
May 16, 2007
Last Updated
October 25, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00474760
Brief Title
Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors
Official Title
Phase 1, Open Label, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP 751,871 In Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Ewing's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-751,871
Intervention Description
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 150 days after the last administration of study drug
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) in Cycle 1
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Maximum Observed Plasma Concentration (Cmax) in Cycle 4
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Plasma Decay Half-Life (t1/2) in Cycle 1
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Plasma Decay Half-Life (t1/2) in Cycle 4
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Systemic Clearance (CL) in Cycle 1
Description
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Systemic Clearance (CL) in Cycle 4
Description
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Concentration at End of Infusion (Cendinf) in Cycle 1
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Concentration at End of Infusion (Cendinf) in Cycle 4
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Volume of Distribution (Vz) in Cycle 1
Description
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.
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Volume of Distribution (Vz) in Cycle 4
Description
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.
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Volume of Distribution at Steady State (Vss) in Cycle 1
Description
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.
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Volume of Distribution at Steady State (Vss) in Cycle 4
Description
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.
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1
Description
Area under the plasma concentration time-curve from zero to the last measured concentration
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4
Description
Area under the plasma concentration time-curve from zero to the last measured concentration
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1
Description
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1
Time Frame
Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4
Time Frame
Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Title
Human Anti-human Antibodies (HAHA) Levels
Description
HAHA were indicators of immunogenicity to figitumumab.
Time Frame
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)
Title
Number of Circulating Tumor Cells (CTCs)
Description
Quantification of CTCs using an automated microscope system
Time Frame
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
Title
Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
Description
Quantification of IGF-IR positive CTCs using an automated microscope system
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Ewing's sarcoma family tumors Exclusion Criteria: Concurrent treatment with any other anti tumor agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0848
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pfizer Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22682017
Citation
Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.
Results Reference
derived
PubMed Identifier
20036194
Citation
Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol. 2010 Feb;11(2):129-35. doi: 10.1016/S1470-2045(09)70354-7. Epub 2009 Dec 23.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021010&StudyName=Study%20Of%20Anti-IGF-IR%20CP-751%2C871%20In%20Patients%20With%20Solid%20Tumors
Description
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Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

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