Phase 2
N=10
Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
Ewing's Sarcoma Family of Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00560235 ↗Enrolled (actual)
10
Serious AEs
48.6%
Results posted
Feb 2014
Primary outcome: Primary: Objective Response Rate (ORR) — 14.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CP-751,871 (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
14.2 | — |
| SECONDARY Progression-Free Survival (PFS) |
1.9 | — |
| SECONDARY Overall Survival (OS) |
8.9 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
513.2; 1075; 975.6; 729.0; 1133; 1043 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) |
389.0; 345.0; 283.6 | — |
| SECONDARY Plasma Concentration at End of Infusion (Cendinf) |
513.2; 1075; 975.6; 729.0; 1133; 1043 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) |
423000; 475000; 302900 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
187200; 338800; 343000; 423000; 509000; 310800 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibody (ADA) Titer |
— | — |
Summary
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00560235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.