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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560235
First received: November 15, 2007
Last updated: January 14, 2014
Last verified: January 2014

November 15, 2007
January 14, 2014
March 2008
March 2010   (final data collection date for primary outcome measure)
Objective Response Rate (ORR) [ Time Frame: Baseline and every cycle (4 weeks), for up to 6 cycles ] [ Designated as safety issue: No ]
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.
Safety and efficacy of CP-751,871 in this patient population
Complete list of historical versions of study NCT00560235 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival (PFS) [ Time Frame: Baseline and every cycle (4 weeks), until progression or death ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Cycle 6: predose on Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Cycle 5: 1 hour post-infusion on Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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.
PK
Not Provided
Not Provided
 
Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ewing's Sarcoma Family of Tumors
Drug: CP-751,871
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity
Experimental: 1
Intervention: Drug: CP-751,871
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
October 2012
March 2010   (final data collection date for primary outcome measure)

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
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Chile,   France,   Germany,   Israel,   Italy,   Spain,   United Kingdom
 
NCT00560235
A4021020
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

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