Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

This study has been terminated.

(Study closed due to slow enrollment)

Sponsor:

Information provided by:

Exelixis

ClinicalTrials.gov Identifier:

NCT00234481

First received: October 5, 2005

Last updated: June 2, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	October 5, 2005
Last Updated Date	June 2, 2008
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00234481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia
Official Title ^ICMJE	A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia
Brief Summary	The purpose of this study is to assess the safety and tolerability of different doses of XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Intervention ^ICMJE	Drug: XL844
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Prior treatment with at least 2 systemic chemotherapy regimens for CLL Life expectancy of >3 months Adequate liver and kidney function Absolute neutrophil count ≥500/mm3; platelets ≥50,000/dL; hemoglobin ≥9 g/dL Willing to use accepted method of contraception during the course of the study Negative pregnancy test (females) Written informed consent Exclusion Criteria: Chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on the therapy) Investigational drug within 30 days of the start of treatment Uncontrolled intercurrent illness such as infection or cardiovascular disease Pregnant or breastfeeding women Subjects known to be HIV positive
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

Administrative Information
NCT Number ^ICMJE	NCT00234481
Other Study ID Numbers ^ICMJE	XL844-001
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Exelixis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Exelixis
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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