Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML) - Tabular View

Tracking Information
First Received Date ^ICMJE	March 8, 2004
Last Updated Date	February 11, 2009
Start Date ^ICMJE	October 2003
Estimated Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 26, 2007)	Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery. [ Time Frame: 113 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00079482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 26, 2007)	- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML)
Official Title ^ICMJE	A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations
Brief Summary	The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Acute Myeloid Leukemia
Intervention ^ICMJE	Drug: lestaurtinib
Study Arms / Comparison Groups	Active Comparator: Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of 1 to 6 months, the induction regimen will be MEC. Active Comparator: Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of more than 6 months to 24 months, the induction regimen will be HiDAC.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	220
Estimated Completion Date	April 2009
Estimated Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: cytological confirmation of AML; relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days; confirmation of FLT-3 activating mutation positive status after point of initial relapse; aged 18 years or older; written informed consent; ability to understand and comply with study restrictions; no comorbid conditions that would limit life expectancy to less than 3 months; ECOG Performance Score of 0, 1,or 2; women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry Exclusion criteria: bilirubin > 2x ULN; ALT/AST > 3x ULN; serum creatinine > 1.5 mg/dL; resting ejection fraction of left ventricle l < 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC]; untreated or progressive infection; any physical or psychiatric cdtn that may compromise participation in the study; known CNS involvement with AML; any previous treatment with a FLT-3 inhibitor; requires current treatment for HIV with protease inhibitors; active GI ulceration or bleeding; use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Canada, Germany, Israel, Italy, New Zealand, Poland, Romania, Russian Federation, Spain, Sweden, Ukraine

Administrative Information
NCT ID ^ICMJE	NCT00079482
Responsible Party	Sponsor's Medical Expert, Cephalon
Study ID Numbers ^ICMJE	C701a/204/ON/US
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cephalon
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP