A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor (TKI) - Failure in Patients With Renal Cancer

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

This is a single-arm phase II trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib.

Key facts

Study ID

NCT00448721

Run by

AEterna Zentaris

People needed

24

Starts

2007-03-01

Expected to finish

2011-10-01

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). There must be histologic confirmation by the treating center of either the primary or a metastatic lesion
• Patients must have experienced disease progression by RECIST criteria while on sorafenib or sunitinib
• Patients must be off of sorafenib or sunitinib for >= 2 weeks prior to initiation of perifosine and <= 3 months prior to enrollment
• Patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy
• Patients must have measurable disease that is not curable by standard radiation therapy or surgery
• Age >= 18 years
• ECOG performance status 0 or 1
• - Patients must have the ability to understand and willingness to sign a written informed consent document

You may not qualify if…

• History or clinical evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke
• Other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage IV disease
• Patients may have had prior sorafenib OR sunitinib and cannot have been treated with both TKIs
• Patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed
• Patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib
• Prior Thalidomide or IFNα are allowed for adjuvant therapy or stage IV disease
• Patients may not have had prior mTOR inhibitors (CCI-779, RAD001)

Where it is running

• Investigative Site — Duarte, California, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Investigative Site — Philadelphia, Pennsylvania, United States
• Investigative Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.