Clinical trial · Interventional
A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor (TKI) - Failure in Patients With Renal Cancer
A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
NCT00448721CI-TRIAL-00031884completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perifosine | Drug | Perifosine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perifosine
- description
- Perifosine will be administered orally at 100mg PO daily with food. One treatment cycle will consist of 42 days (6 weeks).
- interventionNames
- Drug: Perifosine
Primary outcomes (1)
- measure
- To estimate the progression free survival
- timeFrame
- Every 6 weeks
- description
- To estimate the progression free survival of Multi-Targeted Kinase Inhibitor (TKI) resistant patients with metastatic Renal Cell Carcinoma (RCC) who are treated with perifosine
Secondary outcomes (5)
- measure
- To determine the objective response rate of perifosine
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (1)
- RESULTJournal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: 5101