Trial · NCT02303262
SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma
NCT02303262, Phase 2, Completed, Sarcoma Alliance for Research through Collaboration; results first posted 2019-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma. Trials, record NCT02303262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02303262
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma
- NCT number
- NCT02303262
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Conditions
- Metastatic Leiomyosarcoma
- Interventions
- Mocetinostat, Gemcitabine
- First posted
- 2014-11-27
- Last updated
- 2019-01-29
- Results first posted
- 2019-01-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (Per RECIST 1.1) | 27 months | Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions. |
| Secondary | Duration of Response | 27 months | The duration of objective response will be measured from the time measurement criteria are first met until disease progression is objectively documented. |
| Secondary | Progression Free Survival (PFS) | 27 months | Progression free survival is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression Free Survival (PFS) is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression will be assessed by RECIST v. 1.1. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (Per RECIST 1.1) | 27 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response | 27 months | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | 27 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Per RECIST 1.1) | Mocetinostat and Gemcitabine | 1 | Participants | ||
| Duration of Response | Mocetinostat and Gemcitabine | 2 | 95% Confidence Interval 1.5 to 3.1 | months | |
| Progression Free Survival (PFS) | Mocetinostat and Gemcitabine | 2.0 | 95% Confidence Interval 1.5 to 3.1 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mocetinostat and Gemcitabine | 20 | |
| Overall Study | COMPLETED | Mocetinostat and Gemcitabine | 18 | |
| Overall Study | NOT COMPLETED | Mocetinostat and Gemcitabine | 2 |
Source ClinicalTrials.gov
Adverse events105
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 | Absolute neutrophil count decreased | Investigations | Mocetinostat and Gemcitabine | 1 | 20 | 3 |
| other | Achy | General disorders | Mocetinostat and Gemcitabine | 1 | 20 | 1 |
| other | Acid reflux | Gastrointestinal disorders | Mocetinostat and Gemcitabine | 2 | 20 | 2 |
| other | Alanine Aminotransferase increased | Investigations | Mocetinostat and Gemcitabine | 1 | 20 | 2 |
| other | Alkaline phosphatase increased | Investigations | Mocetinostat and Gemcitabine | 2 | 20 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Mocetinostat and Gemcitabine | 8 | 20 | 28 |
| other | Anorexia | Metabolism and nutrition disorders | Mocetinostat and Gemcitabine | 6 | 20 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Mocetinostat and Gemcitabine | 1 | 20 | 3 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Mocetinostat and Gemcitabine | 2 | 20 | 2 |
| other | Bruising | Injury, poisoning and procedural complications | Mocetinostat and Gemcitabine | 1 | 20 | 1 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mocetinostat and Gemcitabine | 0 | 20 |
| Total, other adverse events | Mocetinostat and Gemcitabine | 20 | 20 |
| Total, serious adverse events | Mocetinostat and Gemcitabine | 12 | 20 |
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 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/NCT02303262
GET https://conductscience.org/api/trials/v1/NCT02303262/events?page=2