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| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2006 | ||||
| Last Updated Date | April 4, 2008 | ||||
| Start Date ICMJE | October 2006 | ||||
| Estimated Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Response rate [ Time Frame: Every 4 weeks ] | ||||
| Original Primary Outcome Measures ICMJE |
Response rate | ||||
| Change History | Complete list of historical versions of study NCT00398710 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia | ||||
| Official Title ICMJE | A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia | ||||
| Brief Summary | This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks. |
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| Detailed Description | This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks. Patients will take three 50 mg tablets of perifosine qhs daily (for 28 days cycles) with food. Patients may need anti-emetics and/or anti-diarrheas. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Patients with progressive disease or who refuse further therapy will be discontinued from the protocol. Dose modifications for toxicity will be performed. Standard criteria for evaluation of response in WM recommended by the Second International WM Workshop will be used in this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Waldenström's Macroglobulinemia | ||||
| Intervention ICMJE | Drug: Perifosine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 37 | ||||
| Estimated Completion Date | March 2009 | ||||
| Estimated Primary Completion Date | August 2008 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00398710 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | Perifosine 221 | ||||
| Study Sponsor ICMJE | Keryx / AOI Pharmaceuticals, Inc. | ||||
| Collaborators ICMJE | Dana-Farber Cancer Institute | ||||
| Investigators ICMJE |
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| Information Provided By | Keryx / AOI Pharmaceuticals, Inc. | ||||
| Verification Date | April 2008 | ||||
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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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