A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma
|ClinicalTrials.gov Identifier: NCT02029430|
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Kaposi's Sarcoma HIV+ HIV Positive AIDS||Drug: aldoxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Phase 2 Study to Investigate Efficacy, Safety, and Intratumoral Kinetics of ALDOXORUBICIN in HIV-Infected Patients With Kaposi's Sarcoma|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||October 2016|
Subjects will receive either 100 or 150 mg/m2 (75, and 110 mg/m2 doxorubicin equivalents) by intravenous infusion (IVI) to 10 subjects in each group.
Other Name: INNO-206
- Objective Response Rate [ Time Frame: up to 6 months ]To evaluate the uptake of aldoxorubicin into the tumor and the objective response rate (complete and partial response) using RECIST 1.1 criteria in subjects with HIV-infected with Kaposi's sarcoma
- Safety [ Time Frame: up to 6 months ]To evaluate the safety of ALDOXORUBICIN in this population, assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight.
- Kinetics [ Time Frame: up to 6 months ]To evaluate the intratumoral kinetics of ALDOXORUBICIN and related biomarker expression through sequential biopsies of KS skin lesions.
- Performance Status [ Time Frame: up to 6 months ]To determine the change in performance status (PS) as measured by the Karnofsky Performance Status (KPS).
- Quality of Life [ Time Frame: 6 months ]To determine the change in quality of life as measured by the KS Functional Assessment of HIV (FAHI) Quality of Life instrument (QoLI)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029430
|United States, Louisiana|
|Louisiana State University Health Science Center|
|New Orleans, Louisiana, United States, 70112|