Trial · NCT01495598
Pomalidomide for Kaposi Sarcoma in People With or Without HIV
NCT01495598, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-11-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pomalidomide for Kaposi Sarcoma in People With or Without HIV. Trials, record NCT01495598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01495598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pomalidomide for Kaposi Sarcoma in People With or Without HIV
- NCT number
- NCT01495598
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Kaposi Sarcoma, Sarcoma, Kaposi
- Interventions
- Pomalidomide
- First posted
- 2011-12-20
- Last updated
- 2022-11-01
- Results first posted
- 2022-11-01
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day. | Adverse events (AE's) that are possibly, probably, and/or definitely attributed to pomalidomide were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. |
| Primary | Progression Free Survival (PFS) | time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months | PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions. |
| Primary | Maximal Plasma Concentration (Cmax) of Pomalidomide | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California). |
| Primary | Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Time to maximum observed serum concentration of Pomalidomide was reported. |
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Area under the plasma concentration versus time curve (AUC) was calculated using the log-linear trapezoidal method. The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Primary | Area Under the Curve Extrapolated to Infinity (AUCinf) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | AUC is a measure of the serum concentration of Pomalidomide over time. It is used to characterize drug absorption. The AUC extrapolated to infinity was used, unless the percent extrapolated exceeded 25% in which case AUC to the last quantifiable time point (AUCLast) was used. The steady-state exposure on Day 15 of cycle 1 was calculated using AUCLast. |
| Primary | Half-Life of Pomalidomide | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half. |
| Secondary | Antitumor Effect of a Second Course of Pomalidomide | After completion of 2 cycles of therapy up to 48 weeks after the start of the second course of Pomalidomide | Antitumor effect of pomalidomide was assessed at the established tolerated dose after a second course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions. |
| Secondary | Antitumor Effect of a First Course of Pomalidomide | After completion of 2 cycles of therapy up to 48 weeks | Antitumor effect of pomalidomide was assessed at the established tolerated dose after a first course of pomalidomide. Kaposi sarcoma responses were assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Complete Response (CR) required clinical resolution of all lesions and tumor-associated phenomenon with biopsy confirmation. Clinical Complete Response (cCR) is resolution of all lesions except for some residual pigmentation but who did not have a biopsy of a representative pigmented area. Partial Response (PR) required ≥ 50% decrease in the number of lesions and/or sum product of the diameters of marker lesions and/or nodularity of lesions, and no new lesions in previously uninvolved areas or criteria. Stable Disease (SD) was assessed for all participants who did not meet criteria doe CR, PR, or PD. And progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions. |
| Secondary | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks | Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | During each cycle and 4 weeks after completing therapy, with any continuing AE's observed until resolution, approximately 124 months and 1 day. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Progression Free Survival (PFS) | time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months | months | MEDIAN | |
| PRIMARY | Maximal Plasma Concentration (Cmax) of Pomalidomide | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | ng/mL | MEAN | |
| PRIMARY | Time to Maximum Observed Serum Concentration of Pomalidomide (Cmax) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | hours | MEDIAN | |
| PRIMARY | Area Under the Plasma Concentration Versus Time Curve (AUC) to the Last Timepoint (AUCLast) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | hours*ng/mL | MEAN | |
| PRIMARY | Area Under the Curve Extrapolated to Infinity (AUCinf) | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | hours*ng/ml | MEAN | |
| PRIMARY | Half-Life of Pomalidomide | At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15. | hours | MEAN | |
| SECONDARY | Antitumor Effect of a Second Course of Pomalidomide | After completion of 2 cycles of therapy up to 48 weeks after the start of the second course of Pomalidomide | 4/28 participants were eligible for a second course of pomalidomide at time of progression within 12 months of treatment cessation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antitumor Effect of a First Course of Pomalidomide | After completion of 2 cycles of therapy up to 48 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) | Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks | Missing responses within questionnaire in category FAHI Total at baseline (n=21). And missing responses within questionnaire in category FAHI Total after completion of therapy (n=17). | score on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group281
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 1 | Low white cell count | 21 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 2 | Low white cell count | 10 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 3 | Low white cell count | 1 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 4 | Low white cell count | 0 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 1 | Febrile neutropenia | 0 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 2 | Febrile neutropenia | 0 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 3 | Febrile neutropenia | 1 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 4 | Febrile neutropenia | 0 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 1 | Neutropenia | 24 | Participants | |
| Number of Participants With Grades 1-4 Adverse Events That Are Possibly, Probably, and/or Definitely Attributed to Pomalidomide | Grade 2 | Neutropenia | 26 | Participants |
1 to 10 of 281Source ClinicalTrials.gov
See all 281 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pomalidomide 5mg Daily | 28 | |
| Overall Study | COMPLETED | Pomalidomide 5mg Daily | 14 | |
| Overall Study | NOT COMPLETED | Pomalidomide 5mg Daily | 14 |
Source ClinicalTrials.gov
Adverse events205
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Pomalidomide 5mg Daily | 2 | 28 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Pomalidomide 5mg Daily | 7 | 28 | 9 |
| other | Alanine aminotransferase increased | Investigations | Pomalidomide 5mg Daily | 16 | 28 | 47 |
| other | Alkaline phosphatase increased | Investigations | Pomalidomide 5mg Daily | 5 | 28 | 12 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Pomalidomide 5mg Daily | 2 | 28 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pomalidomide 5mg Daily | 1 | 28 | 1 |
| other | Amylase | Investigations | Pomalidomide 5mg Daily | 1 | 28 | 1 |
| other | Anal hemorrhage | Gastrointestinal disorders | Pomalidomide 5mg Daily | 1 | 28 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Pomalidomide 5mg Daily | 22 | 28 | 61 |
| other | Anorexia | Metabolism and nutrition disorders | Pomalidomide 5mg Daily | 3 | 28 | 5 |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pomalidomide 5mg Daily | 4 | 28 |
| Total, other adverse events | Pomalidomide 5mg Daily | 28 | 28 |
| Total, serious adverse events | Pomalidomide 5mg Daily | 12 | 28 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT01495598
GET https://conductscience.org/api/trials/v1/NCT01495598/results?page=2