Skip to main content
OpenTrials
Completed

NCT Number: NCT00474760

Study Of Anti-IGF-IR CP-751,871 In Patients With 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoma, Ewing's Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Sarcoma Sarcoma, Ewing

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Sutton, Surrey, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Ewing's sarcoma family tumors

Exclusion criteria

  • Concurrent treatment with any other anti tumor agents

Treatment and study plan

CP-751,871

Drug

Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) in Cycle 1

    Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

  2. Maximum Observed Plasma Concentration (Cmax) in Cycle 4

    Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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 - ∞).

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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.

  25. 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

  26. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
May 17, 2007
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.