A Phase 2 interventional study of Perifosine in Waldenström's Macroglobulinemia, sponsored by AEterna Zentaris. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-15.
Sponsored by AEterna Zentaris · Phase 2, Interventional, and Treatment
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.
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.
365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's enrollment of 37 is close to the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →AEterna Zentaris is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive perifosine orally at 150 mg daily after food for 28-d cycles.
Drug: Perifosine
150 mg daily (100 mg daily in case of dose reduction)
Also known as: D-21266, KRX-0401
Response rate
Response will include complete remission, partial remission (PR), and minimal response (MR) using serum protein electrophoresis. Response will also be assessed by IgM using nephelometry.
Time frame: Every 4 weeks
Safety
Adverse events will be assessed at each visit and graded according to the National Cancer Institute Common Toxicity Criteria (version 3.0) from the first dose until 30 d after the last dose of perifosine.
Time frame: Every 4 weeks
Time to progression
This will be calculated using Kaplan-Meier methodology.
Time frame: Every 4 weeks
Progression free survival
This will be calculated using Kaplan-Meier methodology.
Time frame: Every 4 weeks
Duration of response
This will be reported among responding patients.
Time frame: Every 4 weeks
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Waldenstrom Macroglobulinemia→
AEterna Zentaris