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

Phase 1

Completed

• Conditions: Ewing's Sarcoma Family of Tumors
• Interventions: Drug: CP-751,871

• Registration Number: NCT00560235
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-19
• Study Start: 2008-03
• Primary Completion: 2010-03
• Disposition First Submitted: 2011-05-18
• Disposition First Submitted QC: 2011-05-18
• Disposition First Posted: 2011-05-20
• Study Completion: 2012-10
• Results First Submitted: 2013-10-24
• Results First Submitted QC: 2014-01-14
• Results First Posted: 2014-02-28
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Ewing's family of tumors
• Current disease state for which there is no curative therapy

Read More

Exclusion Criteria

• Prior anti-IGF-1R therapy
• Concurrent treatment with other anti-cancer agents

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CP-751,871	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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

Name	Time	Method
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Cycle 5: 1 hour post-infusion on Day 1	The dosing interval was 1 cycle (4 weeks) in this study.
Maximum Observed Plasma Concentration (Cmax)	Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Plasma Concentration at End of Infusion (Cendinf)	Cycle 1 Day 2 and Cycle 5 Day 1
Overall Survival (OS)	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.
Number of Participants With Positive Anti-Drug Antibody (ADA) Titer	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.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	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.
Progression-Free Survival (PFS)	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).
Minimum Observed Plasma Trough Concentration (Cmin)	Cycle 6: predose on Day 1	Cmin is the concentration at the end of treatment cycle (next cycle predose).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Oxford, United Kingdom