Clinical trial NCT00560235: Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
Official title: A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ewing's Sarcoma Family of Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 138
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors


Eligibility criteria: Inclusion Criteria:

* Ewing's family of tumors
* Current disease state for which there is no curative therapy

Exclusion Criteria:

* Prior anti-IGF-1R therapy
* Concurrent treatment with other anti-cancer agents

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Baseline and every cycle (4 weeks), for up to 6 cycles
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline and every cycle (4 weeks), until progression or death
measure: Overall Survival (OS)
timeFrame: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: Cycle 6: predose on Day 1
measure: Plasma Concentration at End of Infusion (Cendinf)
timeFrame: Cycle 1 Day 2 and Cycle 5 Day 1
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: Cycle 5: 1 hour post-infusion on Day 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
measure: Number of Participants With Positive Anti-Drug Antibody (ADA) Titer
timeFrame: Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Brisbane
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Lille Cedex
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Petach Tikva
country: Israel
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Esplugues de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Oxford
country: United Kingdom
facility: Pfizer Investigational Site
city: Oxford
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.