Trial of Two Schedules of Perifosine for Patients With Solid Tumors or Lymphomas
|ClinicalTrials.gov Identifier: NCT00389077|
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tumors Lymphomas||Drug: Perifosine||Phase 2|
This is an exploratory phase IIA trial with unique elements of design and patient selection with an aim to:
- Identify responsive tumor types that were not predicted from preclinical and Phase I studies,
- Determine if tumors are more likely to stabilize than shrink, and
- Identify a dose with almost no toxicity.
- To determine whether response (or stabilization) can be observed on either a daily or weekly schedule, or both. Since the efficacy goal of the study is to look for any evidence of activity with perifosine, the daily and weekly arms will be combined when assessing response.
- Response to therapy will be based on either tumor regression (objective response, partial or complete) OR stabilization of disease.
It is not anticipated that this study will provide "proof of principle" regarding the use of perifosine or serve as a pivotal trial for regulatory purposes. Information obtained from this study will be used to design additional trials that will be more definitive in nature.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||558 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIA Trial of Two Schedules of Perifosine|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Perifosine Daily Dose
Daily dose perifosine 50 mg.
Perifosine 50 mg tablets
Experimental: Perifosine Twice Daily Dose
Twice daily dose perifosine 50 mg.
Perifosine 50 mg tablets
- Overall Response Rate (PR + CR) [ Time Frame: Evaluated every 12 weeks ]To determine for each disease category the proportion of patients treated with perifosine who experience a favorable outcome, defined as a complete or partial response; a 50% increase in progression-free survival compared to patient's latest treatment regimen for metastatic disease, or stabilization of disease.
- To Show that doses will be each sufficiently and tolerated [ Time Frame: From date of randomization ]To show that daily 50 mg daily and 50 mg twice-daily doses are each sufficiently well tolerated to ensure good compliance in future studies of these two regimens
- To obtain plasma levels [ Time Frame: Every treatment cycle ]To obtain perifosine plasma levels in a subset of patients to evaluate variability in drug uptake between patients, and to correlate plasma levels with outcomes to insure good compliance in future studies of these two regimens
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389077
|Study Chair:||Timothy Goggins, MD||Fox Valley Hematology and Oncology SC, Appleton|