Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity
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.
Time frame: Baseline and every cycle (4 weeks), for up to 6 cycles
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).
Time frame: Baseline and every cycle (4 weeks), until progression or death
Overall Survival (OS)
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
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)
Cmin is the concentration at the end of treatment cycle (next cycle predose).
Time frame: Cycle 6: predose on Day 1
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)
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Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Providence, Rhode Island, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Seattle, Washington, United States
...and 27 more locations
The dosing interval was 1 cycle (4 weeks) in this study.
Time frame: Cycle 5: 1 hour post-infusion on Day 1
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.
Time frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
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.
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)