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 : February 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tumors Lymphomas||Drug: Perifosine Daily Dose 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|
|Primary Completion Date :||July 2011|
|Study Completion Date :||September 2011|
Experimental: Daily Dose Perifosine
Drug: Perifosine Daily Dose
Daily Dose Perifosine
Experimental: Weekly Dose Perifosine
- Overall Response Rate (PR + CR) [ Time Frame: Evaluated every 12 weeks ]
- Time to Progression [ Time Frame: From date of randomization ]
- Safety [ Time Frame: Every treatment cycle ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389077
|Study Chair:||Timothy Goggins, MD|