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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
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This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.
This study is a Phase I trial. A total of 3 - 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perifosine +Capecitabine | Experimental | One cycle of therapy will be defined as 3 weeks (21 days). Perifosine 50 mg qd (Days 1-21) + Capecitabine 1000 mg/m2 BID (Days 1-14). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perifosine | Drug | Perifosine 50 mg orally once a day (Days 1-21) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity) | The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. A DLT will be defined as any of the following deemed to be related to study drug(s):
| Every 3 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response | The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response Evaluation Criteria in solid tumors (RECIST): Measurable disease is defined as the presence of at least one measurable lesion. Measurable lesions are lesions that can be accurately measured in at least one dimension and fit one of the following criteria:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johanna Bendell,, MD | SCRI Development Innovations, LLC | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086 |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C105905 | perifosine |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine | Drug | Capecitabine 1000 mg/m2 orally twice per day (Days 1-14) |
|
|
| Every 3 cycles after dosing (length of one cycle is 21 days) |
| Time to progression | This is the interval from the initiation of treatment to the time of documented, objective progression using the same methods of evaluation that were used at baseline. In order for a patient to be regarded as having progressive disease, the following criteria must be met:
| Every 3 cycles after dosing (length of one cycle is 21 days) |
| Pharmacokinetic (PK) data for the combination of perifosine and capecitabine | PK data will also be evaluated from all enrolled patients. PK analyses will present peak plasma concentrations (Cmax) as well as Area under the plasma concentration verus time curve (AUC). | Up to cyle 5 no pharmacokinetic samples were obtained. Cycle 1/Day 11 until Cycle 4/Day 11: pharmacokinetic samples obtained 0.5, 1, 2, 4, 6 and 8 hours after dosing |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |