Trial · NCT03781986
APG-115 in Salivary Gland Cancer Trial
NCT03781986, Phase 1, Phase 2, Active not recruiting, University of Michigan Rogel Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. APG-115 in Salivary Gland Cancer Trial. Trials, record NCT03781986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03781986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- APG-115 in Salivary Gland Cancer Trial
- NCT number
- NCT03781986
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Malignant Salivary Gland Cancer, Salivary Gland Cancer
- Interventions
- APG-115, Carboplatin
- First posted
- 2018-12-20
- Last updated
- 2026-07-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Toxicity Endpoint: dose-limiting toxicity (DLT) | 42 days | DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0 |
| Primary | Maximally tolerated dose (MTD) | 42 days | MTD will be determined based on DLTs observed during the first 6 weeks (2 cycles) of study treatment. |
| Primary | Overall response rate | up to 12 months | Overall response rate will be defined as the proportion of patients achieving either complete response (CR) or partial response (PR). Response will be assessed via RECIST v1.1. |
| Secondary | Overall response rate by tumor histology | Until death or end of study; up to approximately 5 years | Overall response rate will be defined as the proportion of patients achieving either complete response (CR) or partial response (PR), assessed via RECIST v1.1 and reported separately for those with histologically confirmed adenoid cystic carcinoma (ACC) versus other malignant salivary gland tumors (non-ACC) |
| Secondary | Duration of response | Until death or end of study; up to approximately 5 years | The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started. |
| Secondary | Progression-free survival | Until death or end of study; up to approximately 5 years | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever is earlier. |
| Secondary | Overall survival | Until death or end of study; up to approximately 5 years | Overall survival (OS) is defined as the duration of time from start of treatment to time of death or end of study. |
| Secondary | Disease control rate | Until death or end of study; up to approximately 5 years | Defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD). Response will be assessed via RECIST v1.1 |
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/NCT03781986
GET https://conductscience.org/api/trials/v1/NCT03781986/registered