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

NCT00474760

Last updated date
Study Location
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0848, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sarcoma, Ewing's
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
9 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Concurrent treatment with any other anti tumor agents

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Sarcoma, Ewing'sStudy Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors NCT00474760
  1. Ann Arbor, Michigan
  2. Rochester, Minnesota
  3. Sutton, Surrey
ALL GENDERS
9 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma, Ewing's
Intervention  ICMJE Drug: CP-751,871
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
Study Arms  ICMJE Experimental: 1
Intervention: Drug: CP-751,871
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2008)
65
Original Enrollment  ICMJE
 (submitted: May 16, 2007)
48
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

  • Concurrent treatment with any other anti tumor agents
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00474760
Other Study ID Numbers  ICMJE A4021010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP