search
Back to results

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

Primary Purpose

Ewing's Sarcoma Family of Tumors

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CP-751,871
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ewing's Sarcoma Family of Tumors

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Overall Survival (OS)
Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Maximum Observed Plasma Concentration (Cmax)
Minimum Observed Plasma Trough Concentration (Cmin)
Cmin is the concentration at the end of treatment cycle (next cycle predose).
Plasma Concentration at End of Infusion (Cendinf)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
The dosing interval was 1 cycle (4 weeks) in this study.
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.
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.

Full Information

First Posted
November 15, 2007
Last Updated
October 6, 2015
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00560235
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ewing's Sarcoma Family of Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-751,871
Intervention Description
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Baseline and every cycle (4 weeks), for up to 6 cycles
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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).
Time Frame
Baseline and every cycle (4 weeks), until progression or death
Title
Overall Survival (OS)
Description
Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Time Frame
Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Title
Minimum Observed Plasma Trough Concentration (Cmin)
Description
Cmin is the concentration at the end of treatment cycle (next cycle predose).
Time Frame
Cycle 6: predose on Day 1
Title
Plasma Concentration at End of Infusion (Cendinf)
Time Frame
Cycle 1 Day 2 and Cycle 5 Day 1
Title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Description
The dosing interval was 1 cycle (4 weeks) in this study.
Time Frame
Cycle 5: 1 hour post-infusion on Day 1
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description
AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
Time Frame
Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Title
Number of Participants With Positive Anti-Drug Antibody (ADA) Titer
Description
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.
Time Frame
Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4399
Country
United States
Facility Name
Pfizer Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Pfizer Investigational Site
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Pfizer Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago, RM
ZIP/Postal Code
7500539
Country
Chile
Facility Name
Pfizer Investigational Site
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Pfizer Investigational Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Pfizer Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80804
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Pfizer Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Pfizer Investigational Site
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22025154
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021020
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs