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

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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

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).

Condition or disease Intervention/treatment Phase
Sarcoma, Ewing's Drug: CP-751,871 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2005
Actual Primary Completion Date : January 2011
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Experimental: 1 Drug: CP-751,871
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

  • Concurrent treatment with any other anti tumor agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474760


Locations
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109-0848
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00474760     History of Changes
Other Study ID Numbers: A4021010
First Posted: May 17, 2007    Key Record Dates
Results First Posted: December 17, 2013
Last Update Posted: December 17, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Sarcoma, Ewing
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs