Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00474760
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : December 17, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 16, 2007
First Posted Date  ICMJE May 17, 2007
Results First Submitted Date  ICMJE October 25, 2013
Results First Posted Date  ICMJE December 17, 2013
Last Update Posted Date December 17, 2013
Study Start Date  ICMJE August 2005
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
Safety and tolerability of CP-751,871
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
  • Maximum Observed Plasma Concentration (Cmax) in Cycle 1 [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]
  • Maximum Observed Plasma Concentration (Cmax) in Cycle 4 [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]
  • 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 ]
  • 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 ]
  • Plasma Decay Half-Life (t1/2) in Cycle 1 [ Time Frame: 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.
  • Plasma Decay Half-Life (t1/2) in Cycle 4 [ Time Frame: 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 [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]
  • 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 ]
  • Systemic Clearance (CL) in Cycle 1 [ Time Frame: 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.
  • Systemic Clearance (CL) in Cycle 4 [ Time Frame: 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 1 [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]
  • 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 ]
  • Volume of Distribution (Vz) in Cycle 1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ]
  • Human Anti-human Antibodies (HAHA) Levels [ 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) ]
    HAHA were indicators of immunogenicity to figitumumab.
  • Number of Circulating Tumor Cells (CTCs) [ 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 ]
    Quantification of CTCs using an automated microscope system
  • Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs [ 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 ]
    Quantification of IGF-IR positive CTCs using an automated microscope system
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2007)
Pharmacokinetics, pharmacodynamics and efficacy of CP-751,871
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma, Ewing's
Intervention  ICMJE Drug: CP-751,871
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
Study Arms  ICMJE Experimental: 1
Intervention: Drug: CP-751,871
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2008)
65
Original Enrollment  ICMJE
 (submitted: May 16, 2007)
48
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

  • Concurrent treatment with any other anti tumor agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474760
Other Study ID Numbers  ICMJE A4021010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP