NCT02029430Phase 2Completed

A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2016-04-25Actual

Enrollment · participants15Actual

Source updated2024-06-11Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Kaposi's Sarcoma; HIV Positive; AIDS

Treatments or interventions studied

50 mg/m2 aldoxorubicinDrug
100 mg/m2 aldoxorubicinDrug
150 mg/m2 aldoxorubicinDrug

Primary outcomes · main study measures

Read the study measures

measure: Objective Response Rate; description: 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. Objective responses will be evaluated using the RECIST 1.1 criteria. Changes (i.e. improvements) in tumor measurements from baseline values will be assigned a status of CR or PR or SD. Objective response measurements will comprise the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.; timeFrame: up to 6 months; measure: Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population; description: 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. * vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) * physical examination * laboratory tests (chemistry, hematology, urinalysis, anion gap); timeFrame: 30 days from last dose, up to 199 days

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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