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

October 6, 2015 updated by: Pfizer

A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Pfizer Investigational Site
  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-062
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Pfizer Investigational Site
  • Chile
    • Santiago, RM
      • Providencia, Santiago, RM, Chile, 7500539
        • Pfizer Investigational Site
  • France
      • Lille Cedex, France, 59020
        • Pfizer Investigational Site
      • Lyon, France, 69373
        • Pfizer Investigational Site
      • Paris, France, 75005
        • Pfizer Investigational Site
      • Villejuif, France, 94805
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Muenchen, Germany, 80804
        • Pfizer Investigational Site
      • Muenster, Germany, 48149
        • Pfizer Investigational Site
  • Israel
      • Jerusalem, Israel, 91120
        • Pfizer Investigational Site
      • Petach Tikva, Israel, 49202
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40136
        • Pfizer Investigational Site
      • Milano, Italy, 20133
        • Pfizer Investigational Site
      • Torino, Italy, 10126
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Valencia, Spain, 46026
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Pfizer Investigational Site
      • London, United Kingdom, NW1 2PG
        • Pfizer Investigational Site
      • Oxford, United Kingdom, OX3 9DU
        • Pfizer Investigational Site
      • Oxford, United Kingdom, OX3 7LJ
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
  • United States
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10065
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4399
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: CP-751,871
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Baseline and every cycle (4 weeks), for up to 6 cycles
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline and every cycle (4 weeks), until progression or death
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
Overall Survival (OS)
Time Frame: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
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
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Minimum Observed Plasma Trough Concentration (Cmin)
Time Frame: Cycle 6: predose on Day 1
Cmin is the concentration at the end of treatment cycle (next cycle predose).
Cycle 6: predose on Day 1
Plasma Concentration at End of Infusion (Cendinf)
Time Frame: Cycle 1 Day 2 and Cycle 5 Day 1
Cycle 1 Day 2 and Cycle 5 Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time Frame: Cycle 5: 1 hour post-infusion on Day 1
The dosing interval was 1 cycle (4 weeks) in this study.
Cycle 5: 1 hour post-infusion on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
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
Number of Participants With Positive Anti-Drug Antibody (ADA) Titer
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4021020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ewing's Sarcoma Family of Tumors

Clinical Trials on CP-751,871

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings