Phase 1 N=65 Treatment

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

Sarcoma, Ewing's

Bottom Line

View on ClinicalTrials.gov: NCT00474760 ↗

Enrolled (actual)

Serious AEs

52.3%

Results posted

Dec 2013

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 3; 3; 3; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: CP-751,871 (Drug)
Age: Pediatric, Adult, Older Adult · 9+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	3; 3; 3; 3; 13; 29	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) in Cycle 1	57.77; 134.7; 211.0; 463.0; 457.5; 392.0	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) in Cycle 4	697.2; 650.8	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1	8.361; 1.147; 1.043; 0.678; 9.394; 3.441	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4	7.541; 4.840	—
SECONDARY Plasma Decay Half-Life (t1/2) in Cycle 1	203.0; 226.0; 252.3; 227.0; 259.6; 319.0	—
SECONDARY Plasma Decay Half-Life (t1/2) in Cycle 4	386.0; 479.7	—
SECONDARY Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1	501.0; 443.0; 523.7; 498.3; 509.5; 666.7	—
SECONDARY Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4	418.7; 743.7	—
SECONDARY Systemic Clearance (CL) in Cycle 1	6.435; 3.600; 4.807; 4.990; 3.846; 3.155	—
SECONDARY Systemic Clearance (CL) in Cycle 4	2.576; 2.612	—
SECONDARY Concentration at End of Infusion (Cendinf) in Cycle 1	57.50; 134.7; 211.0; 463.0; 434.3; 386.3	—
SECONDARY Concentration at End of Infusion (Cendinf) in Cycle 4	685.0; 650.3	—
SECONDARY Volume of Distribution (Vz) in Cycle 1	78.00; 49.00; 70.47; 68.10; 59.34; 60.35	—
SECONDARY Volume of Distribution (Vz) in Cycle 4	61.98; 89.17	—
SECONDARY Volume of Distribution at Steady State (Vss) in Cycle 1	75.05; 47.90; 68.80; 66.90; 59.27; 61.65	—
SECONDARY Volume of Distribution at Steady State (Vss) in Cycle 4	60.84; 86.07	—
SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1	10900; 27500; 43900; 89430; 107900; 102700	—
SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4	166500; 214500	—
SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1	11910; 40000; 57770; 96300; 136000; 154500	—
SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1	10900; 27500; 43170; 89430; 104000	—
SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4	193100	—
SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1	102400	—
SECONDARY Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4	207200	—
SECONDARY Human Anti-human Antibodies (HAHA) Levels	—	—
SECONDARY Number of Circulating Tumor Cells (CTCs)	—	—
SECONDARY Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs	—	—

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).

Eligibility Criteria

Inclusion Criteria

Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria

Concurrent treatment with any other anti tumor agents

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00474760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.