Trial · NCT04305691
Trial of Ixazomib for Kaposi Sarcoma
NCT04305691, Phase 2, Active not recruiting, AIDS Malignancy Consortium
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Ixazomib for Kaposi Sarcoma. Trials, record NCT04305691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04305691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Ixazomib for Kaposi Sarcoma
- NCT number
- NCT04305691
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 41 participants, estimated
- Lead sponsor
- AIDS Malignancy Consortium
- Conditions
- Kaposi Sarcoma, Skin
- Interventions
- Ixazomib Citrate, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2020-03-12
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate | Up to 4 weeks post treatment | The binomial proportion and its 90% one-sided confidence interval will be used to estimate the overall response rate. Response and progression will be evaluated in this study using the acquired Immunodeficiency syndrome (AIDS) Clinical Trials Groups (ACTG) response criteria for Kaposi sarcoma, as outlined in the AIDS Malignancy Consortium (AMC) Kaposi sarcoma Response Evaluation Manual of Procedures (MOP). |
| Secondary | Incidence of adverse events | Up to 4 weeks post treatment | Frequencies of toxicities will be presented by severity at the event and person level; 95% confidence intervals will be computed for the proportion of participants experiencing grade 3 and higher toxicities. The incidence of toxicity-related dose reductions and treatment discontinuations will be summarized. |
| Secondary | Change in Kaposi-sarcoma associated herpes virus (KSHV) viral load (VL) | Baseline up to 4 weeks post treatment | KSHV lytic gene expression over time will be summarized; changes will be graphed and explored using paired t-tests or Wilcoxon signed rank tests. KSHV levels will be correlated with tumor response by computing descriptive statistics and making exploratory comparisons according to response, as well as examining Spearman's rank correlations between tumor size KSHV levels. |
| Secondary | Change in CD4 counts | Baseline up to 4 weeks post treatment | Immune status over time will be summarized; changes in immune status will be graphed and explored using paired t-tests or Wilcoxon signed rank tests. |
| Secondary | Change in human immunodeficiency virus (HIV) VL | Baseline up to 4 weeks post treatment | HIV viral load over time will be summarized; changes in HIV VL will be graphed and explored using paired t-tests or Wilcoxon signed rank tests. HIV levels will be correlated with tumor response by computing descriptive statistics and making exploratory comparisons according to response, as well as examining Spearman's rank correlations between tumor size and HIV levels. |
| Secondary | Complete response rate | Up to 4 weeks post treatment | Complete response will be defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. |
| Other | Change in quality of life | Baseline up to 4 weeks post treatment | General estimating equations will be used to evaluate changes in the functional assessment of HIV Infection (FAHI) + Kaposi sarcoma (KS) (FAHI+KS) questionnaire measures over time, accounting for clustering of responses within participants. There are three supplemental statements regarding participant perception of KS-specific symptoms: pain, swelling, and physical appearance. Agreement with each of these statements is graded using a Likert scale from 0 to 4. Responses to these statements may be dichotomized to reflect positive or negative impact of these symptoms. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA121947 | Consortium for Advancing Management and Prevention of Cancer in People with HIV | SPARANO, JOSEPH A. | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2015 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04305691
GET https://conductscience.org/api/trials/v1/NCT04305691/registered