Pharmacokinetic and Safety Study of Pixantrone in Patients With Metastatic Cancer and Hepatic Impairment (Hepatic)
|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: NCT01632436|
Recruitment Status : Unknown
Verified June 2012 by CTI BioPharma.
Recruitment status was: Active, not recruiting
First Posted : July 3, 2012
Last Update Posted : July 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Drug: Pixantrone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-randomized Cohort Study With Matched Controls Investigating Pharmacokinetic Parameters and Safety of a Single Dose of Pixantrone With Metastatic Cancer and Moderate, Severe, or No Hepatic Impairment.|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||February 2018|
Experimental: Stage 1 -Moderate Hepatic Impairment
Experimental: Stage 2 - Severe Hepatic Impairment
- Pharmacokinetics [ Time Frame: 5 Years ]The following pharmacokinetic parameters will be calculated; CL, Cmax, AUC-Steady State, Tmax, T 1/2, AUCo-TLAST.
- Safety [ Time Frame: 5 Years ]All adverse events that occur during the study will be listed and the number of occurrences of each event will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632436
|United States, Texas|
|UTHSCSA-Cancer Therapy-Research Center|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||John Sarantopoulos, MD||UTHSCSA- Cancer Therapy & Research Center|