Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01049841 | Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors | PHASE1 | COMPLETED | 23 | — | — | Jan 1, 2010 | Mar 1, 2017 | Mar 10, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| perifosine + temsirolimus | EXPERIMENTAL | This is a single arm, phase I study. Eligible patients will receive a loading dose of oral perifosine on the first day, followed by a maintenance dose starting on the second day until progression. Each patient is assigned to a group according to their body surface area (BSA). Temsirolimus will be combined with perifosine at four dose levels to determine the MTD for the combination therapy. Temsirolimus dosing will start on the same day as the perifosine load. |
| Name | Type | Description |
|---|---|---|
| perifosine + temsirolimus | DRUG | The patient will take oral tablets of perifosine at a dose and frequency to be determined their height, weight and time when they enter the study as those entering early will be treated with lower dose levels (dosing frequency will vary from once a week to daily). The patient will receive an intravenous injection of temsirolimus once a week at a dose to be determined by their height, weight and time when they enter the study as those entering early will be treated with lower doses. In addition they will be asked to keep a medicine diary. |
Inclusion Criteria: * Any solid tumor that has failed standard therapy * Patient must have evidence of tumor by CT, MRI, MIBG scan, serum markers, or tissue sampling. * Age ≤ 21 years (age ≤ 35 years for biopsy proven medulloblastoma or neuroblastoma) * Karnofsky/Lansky performance status ≥ 50% (Ka...