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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
Sutton, Surrey, United Kingdom
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to 150 days after the last administration of study drug
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
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Plasma Decay Half-Life (t1/2) in Cycle 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
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
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Systemic Clearance (CL) in Cycle 4
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
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
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.
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution (Vz) in Cycle 4
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.
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution at Steady State (Vss) in Cycle 1
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.
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Volume of Distribution at Steady State (Vss) in Cycle 4
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.
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1
Area under the plasma concentration time-curve from zero to the last measured concentration
Time frame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4
Area under the plasma concentration time-curve from zero to the last measured concentration
Time frame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
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 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
HAHA were indicators of immunogenicity to figitumumab.
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)
Number of Circulating Tumor Cells (CTCs)
Quantification of CTCs using an automated microscope system
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
Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
Quantification of IGF-IR positive CTCs using an automated microscope system
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