Study to Investigate the Pharmacolkinetics of Aldoxorubicin (INNO-206;DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT01706835|
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : December 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: aldoxorubicin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Lable Phase 1 Study to Investigate the Pharmacolkinetics of Aldoxorubicin (INNO-206;DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Aldoxorubicin dosages of 230 mg/m2 or 350 mg/m2 will be given as a 30 minute infusion every 3 weeks for 8 cycles.
Other Name: INNO-206
- Pharmacokinetics [ Time Frame: up to 3 months ]Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.
- Safety [ Time Frame: up to 6 months ]
All subjects who receive any amount of aldoxorubicin will be included in the safety analyses, which will include the following:
- The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.
- Deaths and other SAEs will be tabulated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706835
|United States, California|
|Samuel Oschin Comprehensive Cancer Institute|
|Los Angeles, California, United States, 90048|
|Study Director:||Dan Levitt, MD||CytRx Coorporation|