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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00070616 | Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support | PHASE1 | COMPLETED | 25 | — | — | Dec 1, 2001 | Mar 1, 2005 | Oct 24, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| Palifermin 6 x 60 μg/kg/day | EXPERIMENTAL | The first 3 consecutive daily doses were administered before the initiation of conditioning therapy (study days -11, -10, and -9); 3 additional consecutive daily doses were administered after administration of radiotherapy, chemotherapy and PBPC transplantation (study days 0, 1, and 2). |
| Palifermin 2 x 180 μg/kg/day | EXPERIMENTAL | The first dose was administered on study day -11, 3 days before the initiation of conditioning therapy, and the second dose was given on day 0 after administration of radiotherapy, chemotherapy and the PBPC infusion |
| Name | Type | Description |
|---|---|---|
| Palifermin 6 x 60 μg/kg/day | DRUG | - |
| Palifermin 2 x 180 μg/kg/day | DRUG | - |
| radiotherapy | RADIATION | - |
| Chemotherapy | DRUG | - |
* Patients diagnosed with Non-Hodgkin's Lymphoma, Hodgkin's Disease, Leukemia and Myeloma. - Eligible for treatment with radiation therapy and chemotherapy followed by blood stem cell support.