Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Neuroepithelioma

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

CP-751,871

Pfizer CT.gov Call Center

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 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

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.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

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.

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 plasma concentration time-curve from zero to the last measured concentration

Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).

HAHA were indicators of immunogenicity to figitumumab.

Quantification of CTCs using an automated microscope system

Quantification of IGF-IR positive CTCs using an automated microscope system

Pfizer

The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.

Figitumumab 3 mg/kg

Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.

Figitumumab 6 mg/kg

Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.

Figitumumab 10 mg/kg

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.

Figitumumab 20 mg/kg

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.

Figitumumab 20 mg/kg RP2D

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.

Figitumumab 20 mg/kg RP2D ACC+Sarcoma

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.

Figitumumab 20 mg/kg RP2D ESFT

Total

Less than (<) 70 years

Equal to or greater than (>=) 70 years

Age, Customized

Sex: Female, Male

The study was completed and 2 participants in figitumumab 20 mg/kg RP2D ESFT group were transitioned to compassionate figitumumab treatment as investigators judged they were receiving benefit from the protocol therapy.

Pfizer ClinicalTrials.gov Call Center

SAEs

All enrolled participants who started treatment.

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.

Figitumumab 20 mg/kg RP2D Every 3 Weeks

All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.

Maximum Observed Plasma Concentration (Cmax) in Cycle 1

All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.

Maximum Observed Plasma Concentration (Cmax) in Cycle 4

All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.

Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1

Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4

Plasma Decay Half-Life (t1/2) in Cycle 1

Plasma Decay Half-Life (t1/2) in Cycle 4

Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1

Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4

Systemic Clearance (CL) in Cycle 1

Systemic Clearance (CL) in Cycle 4

Concentration at End of Infusion (Cendinf) in Cycle 1

Concentration at End of Infusion (Cendinf) in Cycle 4

Volume of Distribution (Vz) in Cycle 1

Volume of Distribution (Vz) in Cycle 4

Volume of Distribution at Steady State (Vss) in Cycle 1

Volume of Distribution at Steady State (Vss) in Cycle 4

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1

All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.

Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1

Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4

All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure

Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1

Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4

Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration for dose escalation, RP2D extension, and RP2D ACC and sarcoma extension cohorts, 4 weeks in duration for RP2D ESFT extension cohort).

Figitumumab 3, 6, 10, 20 mg/kg

Per protocol, the presence of HAHA would only be evaluated for those samples with plasma figitumumab concentrations below the limit of quantification (BLQ). Since none of the postdose samples in the study had figitumumab concentrations BLQ, therefore no sample was analyzed for HAHA.

Human Anti-human Antibodies (HAHA) Levels

Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.

Pretreatment CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.

Number of Circulating Tumor Cells (CTCs)

Pretreatment IGF-1R positive CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.

Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs

Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose \[RP2D\] extension cohort.

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma \[ACC\] and sarcoma extension cohort.

Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing's sarcoma family of tumors \[ESFT\] extension cohort.

Spots Global Cancer Trial Database for Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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