Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amgen | INDUSTRY |
Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of palifermin in the blood following administration will be evaluated. The safety of palifermin administration and its effect on reducing mucositis will also be evaluated.
Mucositis is a common side effect to chemotherapy and radiotherapy involving the formation of erythema and ulcerative lesions in the mouth. Mucositis can be serious, resulting in pain requiring interventions such as analgesic medications and the use of parenteral feedings. Currently, no standard therapy is available to prevent or treat mucositis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palifermin 6 x 60 μg/kg/day | Drug |
| ||
| Palifermin 2 x 180 μg/kg/day |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the PK profile of 3 daily intravenous (IV) doses of rHuKGF before total body irradiation (TBI) / high-dose chemotherapy conditioning treatment and after PBPC transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of rHuKGF in subjects with hematologic malignancies undergoing TBI and high-dose chemotherapy followed by PBPC transplantation. | ||
| To assess oral mucositis in subjects receiving rHuKGF. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17896890 | Result | Zia-Amirhosseini P, Hurd DD, Salfi M, Cheah TC, Aycock J, Cesano A. Pharmacokinetics of palifermin administered as the standard dose and as a collapsed dose in patients with hematologic malignancies. Pharmacotherapy. 2007 Oct;27(10):1353-60. doi: 10.1592/phco.27.10.1353. |
| Label | URL |
|---|---|
| FDA-approved Drug Labeling | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| radiotherapy | Radiation |
|
| Chemotherapy | Drug |
|
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided