Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
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ClinicalTrials.gov Identifier: NCT00560235 |
Recruitment Status :
Completed
First Posted : November 19, 2007
Results First Posted : February 28, 2014
Last Update Posted : October 28, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ewing's Sarcoma Family of Tumors | Drug: CP-751,871 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 138 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | March 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
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 |
- 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.
- 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).
- 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.
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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).
- Plasma Concentration at End of Infusion (Cendinf) [ Time Frame: 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.
- 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.
- 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.

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560235
United States, Florida | |
Pfizer Investigational Site | |
Tampa, Florida, United States, 33612-9497 | |
United States, Massachusetts | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Pfizer Investigational Site | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Pfizer Investigational Site | |
New York, New York, United States, 10032 | |
Pfizer Investigational Site | |
New York, New York, United States, 10065 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Philadelphia, Pennsylvania, United States, 19104-4399 | |
United States, Rhode Island | |
Pfizer Investigational Site | |
Providence, Rhode Island, United States, 02903 | |
United States, Tennessee | |
Pfizer Investigational Site | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
Pfizer Investigational Site | |
Dallas, Texas, United States, 75235 | |
United States, Washington | |
Pfizer Investigational Site | |
Seattle, Washington, United States, 98105 | |
Australia, Queensland | |
Pfizer Investigational Site | |
Brisbane, Queensland, Australia, 4029 | |
Australia, Victoria | |
Pfizer Investigational Site | |
Parkville, Victoria, Australia, 3052 | |
Brazil | |
Pfizer Investigational Site | |
São Paulo, SP, Brazil, 04023-062 | |
Canada, Ontario | |
Pfizer Investigational Site | |
Toronto, Ontario, Canada, M5G 1X8 | |
Chile | |
Pfizer Investigational Site | |
Providencia, Santiago, RM, Chile, 7500539 | |
France | |
Pfizer Investigational Site | |
Lille Cedex, France, 59020 | |
Pfizer Investigational Site | |
Lyon, France, 69373 | |
Pfizer Investigational Site | |
Paris, France, 75005 | |
Pfizer Investigational Site | |
Villejuif, France, 94805 | |
Germany | |
Pfizer Investigational Site | |
Berlin, Germany, 13353 | |
Pfizer Investigational Site | |
Freiburg, Germany, 79106 | |
Pfizer Investigational Site | |
Muenchen, Germany, 80804 | |
Pfizer Investigational Site | |
Muenster, Germany, 48149 | |
Israel | |
Pfizer Investigational Site | |
Jerusalem, Israel, 91120 | |
Pfizer Investigational Site | |
Petach Tikva, Israel, 49202 | |
Italy | |
Pfizer Investigational Site | |
Bologna, Italy, 40136 | |
Pfizer Investigational Site | |
Milano, Italy, 20133 | |
Pfizer Investigational Site | |
Torino, Italy, 10126 | |
Spain | |
Pfizer Investigational Site | |
Esplugues de Llobregat, Barcelona, Spain, 08950 | |
Pfizer Investigational Site | |
Barcelona, Spain, 08035 | |
Pfizer Investigational Site | |
Madrid, Spain, 28046 | |
Pfizer Investigational Site | |
Valencia, Spain, 46026 | |
United Kingdom | |
Pfizer Investigational Site | |
Sutton, Surrey, United Kingdom, SM2 5PT | |
Pfizer Investigational Site | |
London, United Kingdom, NW1 2PG | |
Pfizer Investigational Site | |
London, United Kingdom, SW3 6JJ | |
Pfizer Investigational Site | |
Oxford, United Kingdom, OX3 7LJ | |
Pfizer Investigational Site | |
Oxford, United Kingdom, OX3 9DU |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00560235 |
Other Study ID Numbers: |
A4021020 |
First Posted: | November 19, 2007 Key Record Dates |
Results First Posted: | February 28, 2014 |
Last Update Posted: | October 28, 2015 |
Last Verified: | October 2015 |
Sarcoma Sarcoma, Ewing Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue |