An Open-Label Extended-Use Study of Oral CEP-701 in Patients With Hematologic Malignancies Who Have Participated in a Clinical Study of CEP-701

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

- Patients meets 1 of the following criteria:
>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included in this study if in the opinion of their physician they might benefit by receiving oral CEP-701, and they are withdrawn from C0701a/204/ON/US for additional chemotherapy or haematopoietic stem cell transplantation.
- Aged 18 years or older.
- Written informed consent is obtained.
- Diagnosis of 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
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

Exclusion Criteria

- 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
- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of long term administration of CEP 701 in patients with haematologic malignancies.;Secondary Objective: To measure the time to objective disease progression. ;Primary end point(s): Safety and tolerability will be assessed by evaluating:<br>- incidence, intensity, and attribution of treatment-emergent adverse events<br>- serum chemistry, haematology, and urine laboratory values<br>- vital signs and physical examinations<br>- the administration of concomitant medications<br><br>Objective disease progression as determined by routine haematology.<br>

Secondary Outcome Measures

Name	Time	Method

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