Trial · NCT02049905
Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
NCT02049905, Phase 3, Completed, ImmunityBio, Inc.; results first posted 2024-06-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study to Treat Patients With Soft Tissue Sarcomas. Trials, record NCT02049905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02049905
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
- NCT number
- NCT02049905
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 433 participants, actual
- Lead sponsor
- ImmunityBio, Inc.
- Conditions
- Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma
- Interventions
- Aldoxorubicin, Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
- First posted
- 2014-01-30
- Last updated
- 2024-06-13
- Results first posted
- 2024-06-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 24 months | PFS is defined as the time from the date of randomization to first documentation of objective tumor progression, according to RECIST 1.1 Criteria, or to death due to any cause in the absence of previous documentation of objective tumor progression. For subjects without documentation of objective tumor progression, who started other anti-tumor treatment, or lost to follow up/withdrew consent prior to confirmed progression, PFS is censored at the date of the last tumor assessment. PFS is defined as the interval from the date of randomization to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first. PD is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered PD. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | 24 months | 5 patients were randomized, but not treated on Aldoxorubicin arm. 8 patients were randomized, but not treated on Investigator's Choice of Treatment. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Aldoxorubicin | 4.04 | 95% Confidence Interval 2.79 to 4.83 | Months | |
| Progression-Free Survival (PFS) | Investigator's Choice of Treatment | 2.96 | 95% Confidence Interval 2.63 to 4.17 | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aldoxorubicin | 218 | |
| Overall Study | STARTED | Investigator's Choice of Treatment | 215 | |
| Overall Study | Safety Population | Aldoxorubicin | 213 | |
| Overall Study | Safety Population | Investigator's Choice of Treatment | 207 | |
| Overall Study | COMPLETED | Aldoxorubicin | 213 | |
| Overall Study | COMPLETED | Investigator's Choice of Treatment | 207 | |
| Overall Study | NOT COMPLETED | Aldoxorubicin | 5 | |
| Overall Study | NOT COMPLETED | Investigator's Choice of Treatment | 8 |
Source ClinicalTrials.gov
Adverse events376
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 | Nausea | Gastrointestinal disorders | Aldoxorubicin | 108 | 213 | |
| other | Nausea | Gastrointestinal disorders | Investigator's Choice of Treatment | 91 | 207 | |
| other | Stomatitis | Gastrointestinal disorders | Aldoxorubicin | 114 | 213 | |
| other | Stomatitis | Gastrointestinal disorders | Investigator's Choice of Treatment | 31 | 207 | |
| other | Diarrhoea | Gastrointestinal disorders | Aldoxorubicin | 48 | 213 | |
| other | Diarrhoea | Gastrointestinal disorders | Investigator's Choice of Treatment | 62 | 207 | |
| other | Vomiting | Gastrointestinal disorders | Aldoxorubicin | 60 | 213 | |
| other | Vomiting | Gastrointestinal disorders | Investigator's Choice of Treatment | 44 | 207 | |
| other | Constipation | Gastrointestinal disorders | Aldoxorubicin | 63 | 213 | |
| other | Constipation | Gastrointestinal disorders | Investigator's Choice of Treatment | 33 | 207 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aldoxorubicin | 148 | 213 |
| Total, all-cause mortality | Investigator's Choice of Treatment | 131 | 207 |
| Total, other adverse events | Aldoxorubicin | 209 | 213 |
| Total, other adverse events | Investigator's Choice of Treatment | 203 | 207 |
| Total, serious adverse events | Aldoxorubicin | 91 | 213 |
| Total, serious adverse events | Investigator's Choice of Treatment | 68 | 207 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aldoxorubicin vs Investigator's Choice of Treatment: deaths from any cause | Trial comparisons |
| Aldoxorubicin vs Investigator's Choice of Treatment: serious adverse events | Trial comparisons |
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/NCT02049905
GET https://conductscience.org/api/trials/v1/NCT02049905/events?page=2