Trial · NCT05809830
Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas
NCT05809830, Phase 1, Phase 2, Active not recruiting, Grupo Espanol de Investigacion en Sarcomas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas. Trials, record NCT05809830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05809830
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas
- NCT number
- NCT05809830
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 152 participants, estimated
- Lead sponsor
- Grupo Espanol de Investigacion en Sarcomas
- Conditions
- Advanced Soft-tissue Sarcoma
- Interventions
- LB-100 plus Doxorrubicin, Doxorubicin
- First posted
- 2023-04-12
- Last updated
- 2025-03-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximun Tolerated Dose (MTD) (Phase I) | After six months | The MTD of LB-100 in combination with doxorubicin will be determined by assessing adverse events according to CTCAE v5.0. |
| Primary | Progression-free survival (PFS) (Phase II) | After two years | Efficacy measured by median PFS according to RECIST v1.1 |
| Secondary | Adverse Events (Phase I and II) | Between six months and two years | Safety profile/Toxicity assessed by adverse events related to study drugs |
| Secondary | Overall Response Rate (ORR) (Phase I and II) | Between six months and two years | Efficacy measured by the ORR, which is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects. |
| Secondary | Progression-free survival (PFS) (Phase I) | After six months | Efficacy measured by median PFS according to RECIST v1.1 |
| Secondary | Overall survival (OS) (Phase I and II) | Between six months and two years | Censored on the last date a subject was known to be alive |
| Secondary | EORTC QLQ-C30 questionnaire (Phase I and II) | Between six months and two years | Quality of life assessed by using the EORTC QLQ-C30 questionnaire. |
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.
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/NCT05809830
GET https://conductscience.org/api/trials/v1/NCT05809830/registered