Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors

Ewing's Sarcoma Family of Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560235
• Other study ID #: A4021020
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 15, 2007
• Last updated: October 6, 2015
• Start date: March 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ewing's Sarcoma Family of Tumors
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• CP-751,871
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Brisbane	Queensland
Australia	Pfizer Investigational Site	Parkville	Victoria
Brazil	Pfizer Investigational Site	São Paulo	SP
Canada	Pfizer Investigational Site	Toronto	Ontario
Chile	Pfizer Investigational Site	Providencia	Santiago, RM
France	Pfizer Investigational Site	Lille Cedex
France	Pfizer Investigational Site	Lyon
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Villejuif
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenster
Israel	Pfizer Investigational Site	Jerusalem
Israel	Pfizer Investigational Site	Petach Tikva
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Torino
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Esplugues de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Valencia
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Oxford
United Kingdom	Pfizer Investigational Site	Oxford
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Rochester	Minnesota
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Chile,  France,  Germany,  Israel,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as =30% decrease under baseline of the sum of diameters of all target lesions.	Baseline and every cycle (4 weeks), for up to 6 cycles	No
Secondary	Progression-Free Survival (PFS)	PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).	Baseline and every cycle (4 weeks), until progression or death	No
Secondary	Overall Survival (OS)	Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.	Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin)	Cmin is the concentration at the end of treatment cycle (next cycle predose).	Cycle 6: predose on Day 1	No
Secondary	Plasma Concentration at End of Infusion (Cendinf)		Cycle 1 Day 2 and Cycle 5 Day 1	No
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	The dosing interval was 1 cycle (4 weeks) in this study.	Cycle 5: 1 hour post-infusion on Day 1	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.	Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1	No
Secondary	Number of Participants With Positive Anti-Drug Antibody (ADA) Titer	Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.	Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)	Yes

External Links

•   To obtain contact information for a study center near you, click here.