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

• ClinicalTrials.gov Identifier: NCT00560235
• Recruitment Status: Completed
• First Posted: November 19, 2007
• Results First Posted: February 28, 2014
• Last Update Posted: October 28, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ewing's Sarcoma Family of Tumors	Drug: CP-751,871	Phase 1; Phase 2

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 ]
4. 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).
5. Plasma Concentration at End of Infusion (Cendinf) [ Time Frame: Cycle 1 Day 2 and Cycle 5 Day 1 ]
6. 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.
7. 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.
8. 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00560235
• Other Study ID Numbers: A4021020
• First Posted: November 19, 2007
• Results First Posted: February 28, 2014
• Last Update Posted: October 28, 2015
• Last Verified: October 2015

Additional relevant MeSH terms:

Sarcoma; Sarcoma, Ewing; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue