An open label extended study use of oral CEP-701 in patients with haematologic and non-haematologic malignancies who have participated in a clinical study of CEP-701 - ND

CEPHALON EUROPE0 sites100 target enrollmentMay 25, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Haematologic and non-haematologig malignancies in patients who have participated in clinical studies with CEP-701
Sponsor: CEPHALON EUROPE
Enrollment: 100
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

May 25, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CEPHALON EUROPE

•The patient participated 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 and older written informed consent is obtained The patient has a diagnosis of haematologic or non\-haematologic malignancy The 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. The patient must enter the study within 30 days of participating in the previous clinical study of CEP\-701; or if the patient received chemotherapy after the previous study of CEP\-701, within a window of 3 to 14 days after receiving the last dose of chemotherapy women must be neither pregnant nor lactating, and either of non\-childbearing 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
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•active gastrointestinal ulceration or bleeding bilirubin levels greater than 2 times upper limit of normal ULN , alanine transaminase or aspartate transaminase levels greater than 3 times ULN serum creatinine concentrations greater than 2\.0 mg/dL The patient has a non\-haematological malignancy and one or more of the following abnormal haematologic values \- haemoglobin below 9 g/dL \- patelets count below 100000/ 956;L \- absolute neutrophil counts below 1500 / 956;L The patient requires current treatment for the human immunodeficiency virus with protease inhibitors or requires potent CYP3A4 inhibitors cyclosporine, clotrimazole, fluconazole, itraconazole, voriconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin, and nefazodone