Clinical trial NCT00474760: Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma, Ewing's
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 65
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

* Concurrent treatment with any other anti tumor agents

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 150 days after the last administration of study drug
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Maximum Observed Plasma Concentration (Cmax) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Plasma Decay Half-Life (t1/2) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Plasma Decay Half-Life (t1/2) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Systemic Clearance (CL) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Systemic Clearance (CL) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Concentration at End of Infusion (Cendinf) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Concentration at End of Infusion (Cendinf) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Volume of Distribution (Vz) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Volume of Distribution (Vz) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Volume of Distribution at Steady State (Vss) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Volume of Distribution at Steady State (Vss) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1
timeFrame: Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4
timeFrame: Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose
measure: Human Anti-human Antibodies (HAHA) Levels
timeFrame: 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)
measure: Number of Circulating Tumor Cells (CTCs)
timeFrame: 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
measure: Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs
timeFrame: 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
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.
citation: Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol. 2010 Feb;11(2):129-35. doi: 10.1016/S1470-2045(09)70354-7. Epub 2009 Dec 23.