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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00474760
First received: May 16, 2007
Last updated: October 25, 2013
Last verified: October 2013

May 16, 2007
October 25, 2013
August 2005
January 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Safety and tolerability of CP-751,871
Complete list of historical versions of study NCT00474760 on ClinicalTrials.gov Archive Site
  • Maximum Observed Plasma Concentration (Cmax) in Cycle 1 [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) in Cycle 4 [ Time Frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Systemic Clearance (CL) in Cycle 1 [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Volume of Distribution (Vz) in Cycle 1 [ Time Frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quantification of IGF-IR positive CTCs using an automated microscope system
Pharmacokinetics, pharmacodynamics and efficacy of CP-751,871
Not Provided
Not Provided
 
Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors
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

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma, Ewing's
Drug: CP-751,871
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
Experimental: 1
Intervention: Drug: CP-751,871
Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchère 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
October 2012
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

  • Concurrent treatment with any other anti tumor agents
Both
9 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00474760
A4021010
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

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