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
- Conditions
- Haematologic and non-haematologig malignancies in patients who have participated in clinical studies with CEP-701MedDRA version: 6.1Level: PTClassification code 10059034
- Registration Number
- EUCTR2005-005542-39-IT
- Lead Sponsor
- CEPHALON EUROPE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Safety and tolerability of long term use of CEP-701 in patients affected by advanced malignancies;Secondary Objective: Objective time to disease progression;Primary end point(s): Safety and tolerability of long term use of CEP-701 in patients affected by advanced malignancies
- Secondary Outcome Measures
Name Time Method