Estudio de extensión abierto del fármaco oral CEP-701 en pacientes con enfermedades malignas hematológicas y no hematológicas que han participado en un estudio clínico del CEP-701

Cephalon Inc.0 sites100 target enrollmentFebruary 20, 2006

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with hematologic and non hematologic malignancies who have participated in a clinical study of CEP 701 may participate in this extension study.
Sponsor: Cephalon Inc.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

February 20, 2006

End Date

April 4, 2009

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Participation in a previous clinical study of oral CEP 701 and would benefit by continuing treatment with CEP 701\. Patients randomized to chemotherapy alone in study C0701a/204/ON/US may also be included in this study if in the opinion of their physician they might benefit by receiving oral CEP\-701\.
•\- Aged 18 years or older.
•Written informed consent is obtained.
•\- Diagnosis of hematologic or non hematologic malignancy.
•\- Patient must be willing and able to comply with study restrictions and to return to the clinic for clinical and follow up evaluations as specified in this protocol.
•\- Enter this study within 30 days after participating in the previous clinical study of oral CEP 701; or, if the patient received chemotherapy after the previous study of oral CEP 701, within an interval of 3 to14 days after receiving the final dose of chemotherapy.
•\- Women must be neither pregnant or lactating, and either not of child\-bearing potential or using adequate contraception with a negative pregnancy test result at study entry.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\- Active gastrointestinal ulceration or bleeding.
•\- 1 or more of the following abnormal clinical chemistry laboratory values:
•\-\>bilirubin is more than 2 times the upper limit of normal (ULN)
•\-\>alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than 3 times ULN
•\- Serum creatinine is more than 2\.0 mg/dl
•\- Non hematologic malignancy and 1 or more of the following abnormal hematology values:
•\-\>hemoglobin is below 9 g/dl
•\-\>platelet counts are below 100000/µl
•\-\>Absolute neutrophil counts are below 1500/µl
•\- The patient requires current treatment for the human immunodeficiency virus (HIV) with protease inhibitors or requires potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, voriconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin, and nefazodone