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Register:	EUCTR
Last refreshed on:	1 May 2012
Main ID:	EUCTR2005-005542-39-DE
Date of registration:	20/03/2008
Prospective Registration:	Yes
Primary sponsor:	Cephalon Inc.
Public title:	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
Scientific title:	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
Date of first enrolment:
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005542-39
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Germany	Italy	Spain	Sweden

Contacts

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Key inclusion & exclusion criteria

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included in this study if in the opinion of their physician they might benefit by receiving oral CEP-701, and they are withdrawn from C0701a/204/ON/US for additional chemotherapy or haematopoietic stem cell transplantation.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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with haematologic malignancies who have participated in a clinical study of CEP-701 may participate in this extension study.
MedDRA version: 9.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia

Intervention(s)

Product Name: lestaurtinib
Product Code: CEP-701
Pharmaceutical Form: Oral solution
INN or Proposed INN: Lestaurtinib
CAS Number: 111358-88-4
Current Sponsor code: CEP-701
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Main Objective: To assess the safety and tolerability of long term administration of CEP 701 in patients with haematologic malignancies.

Primary end point(s): Safety and tolerability will be assessed by evaluating:
- incidence, intensity, and attribution of treatment-emergent adverse events
- serum chemistry, haematology, and urine laboratory values
- vital signs and physical examinations
- the administration of concomitant medications

Objective disease progression as determined by routine haematology.

Secondary Objective: To measure the time to objective disease progression.

Secondary Outcome(s)

Secondary ID(s)

2005-005542-39-ES

C0701a/501/ON/US

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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