Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer
This study is currently recruiting participants.
Verified February 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01499303
First received: December 19, 2011
Last updated: February 19, 2013
Last verified: February 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2011 | ||||
| Last Updated Date | February 19, 2013 | ||||
| Start Date ICMJE | December 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage patients with a complete response (CR)or partial response (PR) using the revised response criteria for malignant lymphoma (Cheson et al 2007) [ Time Frame: From randomization until disease progression (expected duration of treatment approximately 6 months) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Percentage of patients with a complete response (CR) or partial response (PR) using the revised response criteria for malignant lymphoma (Cheson et al 2007) [ Time Frame: From randomization until disease progression or discontinuation from study (expected duration of treatment: approximately 6 months) ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01499303 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Learn if 200mg Test Drug (Fostamatinib) Helps People With Large B-Cell Lymphoma,a Type of Blood Cancer | ||||
| Official Title ICMJE | Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL) | ||||
| Brief Summary | This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (abbreviated as DLBCL) |
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| Detailed Description | Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diffuse Large B-Cell Lymphoma | ||||
| Intervention ICMJE | Drug: Fostamatinib
Phase II Trial to evaluate the efficacy of 200mg fostamatinib |
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| Study Arm (s) | Experimental: Fostamatinib 200
200mg fostamatinib bid n=60
Intervention: Drug: Fostamatinib |
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| Publications * | Not Provided | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01499303 | ||||
| Other Study ID Numbers ICMJE | D4302C00001 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | AstraZeneca | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | February 2013 | ||||
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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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