A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).

Tracking Information
First Submitted Date ICMJE	November 25, 2009
First Posted Date ICMJE	November 30, 2009
Last Update Posted Date	December 20, 2010
Study Start Date ICMJE	January 2010
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 25, 2009)	To determine the effect of ketoconazole on the pharmacokinetics of ABT- 263. [ Time Frame: Weekly ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01021358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 25, 2009)	To determine the safety of ABT-263 when administered alone and in combination with Ketoconazole in these patients. [ Time Frame: Daily ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).
Official Title ICMJE	A Phase 1 Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of ABT-263 (Navitoclax)
Brief Summary	This is a single dose, open-label, single or multiple center study to determine the interaction of ketoconazole with ABT-263 in approximately 12 subjects with cancer.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Lymphoma; Chronic Lymphocytic Leukemia; Solid Tumors
Intervention ICMJE	Drug: ABT-263 Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.; Drug: Ketoconazole Subjects will be dosed with ABT-263, then dosed with ABT-263 in combination with Ketoconazole.
Study Arms	Experimental: Arm A (ABT-263 and Ketoconozole); Interventions: Drug: ABT-263; Drug: Ketoconazole
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	Completed
Estimated Enrollment ICMJE; (submitted: November 25, 2009)	12
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 18 years of age or older.; Has a non-hematologic malignancy (radiographic, histologic, or cytologic confirmation), or hematologic malignancy (histologic or cytologic confirmation) that is either: relapsed or refractory to standard therapy, failed at least one prior therapy or no known effective therapy exists.; In the investigator's opinion, the subject's life expectancy is at least 90 days.; If clinically indicated, (e.g., subjects over the age of 70) subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the first dose of study drug.; Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug. Exclusion Criteria: History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.; Has undergone an allogeneic stem cell transplant.; Has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.; Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.; Has active immune thrombocytopenic purpura or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).; Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease. Female subject is pregnant or breast-feeding.; History of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, etc).; Exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: active systemic fungal infection; diagnosis of fever and neutropenia within one week prior to study drug administration.; Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy [ERT], or agonists required to suppress serum testosterone levels [e.g., LHRH, GnRH, etc.] for subjects with prostate cancer; Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function.; Currently receiving or requires anti-fungal treatment or CYP3A inhibitors. In the opinion of the Investigator, the subject is an unsuitable candidate to receive ABT-263.; History of or is clinically suspicious for cancer-related central nervous system (CNS) disease.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01021358
Other Study ID Numbers ICMJE	M10-957
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Andrew Krivoshiik, MD, PhD, Medical Director, Abbott
Study Sponsor ICMJE	Abbott
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Abbott
Verification Date	December 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP