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
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||March 2010|
|Study Completion Date :||October 2012|
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560235
Show 37 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|