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This study is a Phase I trial in two parts. In part 1, a MTD to the combination of perifosine and sorafenib will be determined. In part 2, with the MTD as a starting point, a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least three courses of therapy, which would make them evaluable for response in a Phase II study.
This study is a Phase I trial in two parts. In part 1, an MTD to the combination of perifosine and sorafenib will be determined. The experience with perifosine and other biologic agents has been that doses determined in Phase I studies are not as well tolerated in larger groups of patients when response is an endpoint. Thus in part 2, with the MTD as a starting point, a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least three courses of therapy, which would make them evaluable for response in a Phase II study. The effects of the combination of perifosine and sorafenib will be evaluated for response rate and time to progression. The pharmacokinetics of the combination of the study drugs will be measured.
For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day. Patients may need anti-emetics and/or anti-diarrheals.
All patients should be evaluated at each visit for adverse events. Patients will keep a diary documenting compliance with study drug, toxicities and any symptoms of hand/foot syndrome including numbness, tingling, redness or presence of sores, and any symptoms of hypertension. Patients will be evaluated for progression or response at 12-week intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perifosine + Sorafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perifosine | Drug | For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Response or progression | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Preliminary results / Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 26, No 15S (May 20 Supplement), 2008: 16024 |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C105905 | perifosine |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Sorafenib | Drug | For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients will take perifosine one to three times a day and will also receive sorafenib one to two times a day. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |