Trial · NCT03993106
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS. | Every 4 weeks until study completion (average 6 months). | The observed proportions of participants experiencing clinical response and unacceptable toxicity will be calculated with 95% confidence intervals. For clinical response, the Kaplan-Meier method will be used to estimate the distribution for time to death assessed for up to 1 month after treatment completion; for time to progression assessed from chemotherapy initiation to first documented progression up to 1 month after treatment completion; and for time to response assessed from the first dose until first documented response up to 1 month after completion of treatment. The Kaplan-Meier method will then be used to estimate the distribution of time to response, time to relapse, and time to death. Adverse events will be tabulated according to type and severity. |
| Secondary | Effects of sEphB4-HSA on tumor cell apoptosis and proliferation. | Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days). | Immunohistochemistry will be performed on biopsy samples and levels will be determine pre and post sEphB4-HSA. |
| Secondary | Effects of sEphB4-HSA on immune response as measured in blood | Blood draws at baseline, Cycle 1 Days 1 & 15 (one cycle is 28 days) and Day 1 of Cycles 4, 7, 10 and at study completion (average of 6 months) | Peripheral blood samples will be used for flow cytometric analysis, cytokine measurements, and in vitro studies of T cells. Biopsy samples will be used to perform cytokine assays and evaluate for tumor regression and immune infiltration. |
| Secondary | Effects of sEphB4-HSA on immune response as measured in tissue | Optional skin biopsies at study entry and any Day Cycle 3 (one cycle is 28 days). | Biopsy samples will be used to perform cytokine assays and evaluate for tumor regression and immune infiltration. |
| Secondary | Effects of sEphB4-HSA on viral replication and gene expression of human herpes virus-8 (HHV-8). | Baseline, Cycle 1, Day 1, Day 1 of every third cycle (one cycle is 28 days) thereafter and at study completion (average of 6 months). | HHV-8 copy number in peripheral blood mononuclear cells (PBMC) and plasma will be assessed by real-time quantitative RT-PCR. The same assay will also investigate a set of known endothelial-specific mRNAs (targeted array). |
| Secondary | Changes in the VEGF-Notch-EphrinB2 angiogenic pathway | At study entry and week 8-12 of study drug. | Optional biopsies will be taken and immunohistochemistry will be performed to determine expression for genes in the VEGF-Notch-EphrinB2 pathway. |
| Secondary | Trough levels of recombinant sEphB4-HSA fusion protein | Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days) | Trough levels (lowest concentration of sEphB4-HSA in the participant's bloodstream). sEphB4-HSA levels will be measured from blood draws on which ELISA will be run. |
| Secondary | Cmax levels of recombinant sEphB4-HSA fusion protein | Days 1 and 15 of cycles 1 and 2 (one cycle is 28 days) | Cmax levels (highest concentration of sEphB4-HSA in the participant's bloodstream). sEphB4-HSA levels will be measured from blood draws on which ELISA will be run. |
| Secondary | Quality of Life Questionnaire | Baseline, day 1 of study drug, day 1 of Cycle 4 (one cycle is 28 days), at study completion (average of 6 months) | Five measures of overall quality of life will be scored: physical well-being, emotional well-being, functional and global well-being, social well-being, and cognitive functioning. Changes in these measures will be assessed over time. |
| Secondary | Samples for banking | Optional skin biopsies at baseline, Cycle 1 Day 1 and any Day Cycle 3 (one cycle is 28 days). Blood draws at baseline, Cycle 1 Days 1 & 15 and Day 1 of Cycles 4, 7, 10 and at study completion (average of 6 months) | Archive peripheral blood mononuclear cells (PBMCs) and tissue samples to be used in conjunction with samples collected in subsequent trials of sEphB4-HSA for future studies including identification of biomarkers predictive of response |
| Secondary | Effects of sEphB4-HSA on human immunodeficiency virus (HIV) plasma viral loads in participants with HIV | Baseline, Cycle 1, Day 1, Day 1 of every third cycle thereafter (one cycle is 28 days) and at study completion (average of 6 months). | Peripheral blood will be drawn and viral loads and T-cell counts will be performed. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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