A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).
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ClinicalTrials.gov Identifier: NCT01021358 |
Recruitment Status
:
Completed
First Posted
: November 30, 2009
Last Update Posted
: December 20, 2010
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Sponsor:
Abbott
Information provided by:
Abbott
Tracking Information | |||
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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 |
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 |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Experimental: Arm A (ABT-263 and Ketoconozole)
Interventions:
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |