NCT00560235

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1

Geographic Reach
11 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 28, 2014

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

November 15, 2007

Results QC Date

October 24, 2013

Last Update Submit

October 6, 2015

Conditions

Ewing's Sarcoma Family of Tumors

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Progression-Free Survival (PFS)

    Baseline and every cycle (4 weeks), until progression or death

  • Overall Survival (OS)

    Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment

  • Maximum Observed Plasma Concentration (Cmax)

    Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1

  • Minimum Observed Plasma Trough Concentration (Cmin)

    Cycle 6: predose on Day 1

  • Plasma Concentration at End of Infusion (Cendinf)

    Cycle 1 Day 2 and Cycle 5 Day 1

  • +3 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: CP-751,871

Interventions

CP-751,871DRUG

Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

1

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Pfizer Investigational Site

Tampa, Florida, 33612-9497, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

New York, New York, 10065, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104-4399, United States

Location

Pfizer Investigational Site

Providence, Rhode Island, 02903, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38105, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98105, United States

Location

Pfizer Investigational Site

Brisbane, Queensland, 4029, Australia

Location

Pfizer Investigational Site

Parkville, Victoria, 3052, Australia

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04023-062, Brazil

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 1X8, Canada

Location

Pfizer Investigational Site

Providencia, Santiago, RM, 7500539, Chile

Location

Pfizer Investigational Site

Lille, 59020, France

Location

Pfizer Investigational Site

Lyon, 69373, France

Location

Pfizer Investigational Site

Paris, 75005, France

Location

Pfizer Investigational Site

Villejuif, 94805, France

Location

Pfizer Investigational Site

Berlin, 13353, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

München, 80804, Germany

Location

Pfizer Investigational Site

Münster, 48149, Germany

Location

Pfizer Investigational Site

Jerusalem, 91120, Israel

Location

Pfizer Investigational Site

Petah Tikva, 49202, Israel

Location

Pfizer Investigational Site

Bologna, 40136, Italy

Location

Pfizer Investigational Site

Milan, 20133, Italy

Location

Pfizer Investigational Site

Torino, 10126, Italy

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46026, Spain

Location

Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Pfizer Investigational Site

London, NW1 2PG, United Kingdom

Location

Pfizer Investigational Site

London, SW3 6JJ, United Kingdom

Location

Pfizer Investigational Site

Oxford, OX3 7LJ, United Kingdom

Location

Pfizer Investigational Site

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22025154DERIVED

Related Links

MeSH Terms

Interventions

figitumumab

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 19, 2007

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Study Completion

October 1, 2012

Last Updated

October 28, 2015

Results First Posted

February 28, 2014

Record last verified: 2015-10

Locations

DE(4)AU(2)ES(4)CA(1)GB(5)IT(3)BR(1)IL(2)US(10)CL(1)FR(4)