A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01506934 |
Recruitment Status
:
Terminated
(Sponsor decision)
First Posted
: January 10, 2012
Last Update Posted
: August 28, 2012
|
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | October 11, 2011 | ||
First Posted Date ICMJE | January 10, 2012 | ||
Last Update Posted Date | August 28, 2012 | ||
Study Start Date ICMJE | October 2011 | ||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Calculate the Cmax and Tmax of participating subjects [ Time Frame: PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period. ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT01506934 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
|
||
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 Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors | ||
Official Title ICMJE | A Phase 1, Open Label, Randomized, Adaptive, Cross-Over Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors | ||
Brief Summary | A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib. | ||
Detailed Description | This study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||
Condition ICMJE | Advanced or Metastatic Solid Tumors | ||
Intervention ICMJE | Drug: linifanib
Single Dose on Day 1 of Periods 1, 2 and 3 (Bioavailability Portion) Single Dose on Day 1 of Periods 1 and 2 (Food Effect Portion) Other Name: ABT-869 |
||
Study Arms | Experimental: linifanib
Single Doses
Intervention: Drug: linifanib |
||
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 | ||
Actual Enrollment ICMJE |
14 | ||
Original Estimated Enrollment ICMJE |
48 | ||
Actual Study Completion Date | January 2012 | ||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
|
||
Sex/Gender |
|
||
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 | NCT01506934 | ||
Other Study ID Numbers ICMJE | M12-468 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Abbott | ||
Study Sponsor ICMJE | Abbott | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Abbott | ||
Verification Date | August 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |