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
  Purpose

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 Intervention Phase
Sarcoma, Ewing's
Drug: CP-751,871
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 65
Study Start Date: August 2005
Study Completion Date: October 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   9 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

  • Concurrent treatment with any other anti tumor agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by Pfizer

Additional 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
Study First Received: May 16, 2007
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma, Ewing
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Osteosarcoma
Sarcoma

ClinicalTrials.gov processed this record on October 23, 2014