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

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

Official Title
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A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

Conditions
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Ewing's Sarcoma Family of Tumors

Intervention / Treatment
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* Drug: CP-751,871


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CP-751,871<br>* Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and every cycle (4 weeks), for up to 6 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment | 
| Maximum Observed Plasma Concentration (Cmax) |  | 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). | Cycle 6: predose on Day 1 | 
| Plasma Concentration at End of Infusion (Cendinf) |  | Cycle 1 Day 2 and Cycle 5 Day 1 | 
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | The dosing interval was 1 cycle (4 weeks) in this study. | 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. | 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. | Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose) |