Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560235
First received: November 15, 2007
Last updated: November 8, 2012
Last verified: November 2012
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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 15, 2007 | ||||
| Last Updated Date | November 8, 2012 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety and efficacy, in terms of objective response, of CP-751,871 in this patient population [ Time Frame: 20 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety and efficacy of CP-751,871 in this patient population | ||||
| Change History | Complete list of historical versions of study NCT00560235 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
PK | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors | ||||
| Official Title ICMJE | A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors | ||||
| Brief Summary | Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Ewing's Sarcoma Family of Tumors | ||||
| Intervention ICMJE | Drug: CP-751,871
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: CP-751,871 |
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| Publications * | Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. Epub 2011 Oct 24. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 139 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Brazil, Canada, Chile, France, Germany, Israel, Italy, Spain, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00560235 | ||||
| Other Study ID Numbers ICMJE | A4021020 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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