Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
This study has been completed.
Information provided by (Responsible Party):
First received: November 15, 2007
Last updated: January 14, 2014
Last verified: January 2014
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma Ewing's Sarcoma Ewing's Family of Tumors Osteosarcoma Bone CancerU.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
|Study Start Date:||March 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560235
Show 37 Study Locations
Show 37 Study Locations
Sponsors and Collaborators
|Study Director:||Pfizer CT.gov Call Center||Pfizer|