Trial · NCT02749903
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
NCT02749903, Phase 2, Active not recruiting, Alliance for Clinical Trials in Oncology; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers. Trials, record NCT02749903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02749903
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
- NCT number
- NCT02749903
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma, Salivary Duct Carcinoma, Salivary Gland Adenocarcinoma, NOS, Salivary Gland Basal Cell Adenocarcinoma, Stage III Major Salivary Gland Cancer AJCC v7
- Interventions
- enzalutamide
- First posted
- 2016-04-25
- Last updated
- 2026-10-07
- Results first posted
- 2020-01-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate | Up to 32 weeks | The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. |
| Secondary | Progression-free Survival | Up to 32 months post study enrollment | Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0 | 30 days post-treatment, up to 32 months | The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below. |
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 | Best Overall Response Rate | Up to 32 weeks | percentage of patients | NUMBER | |
| SECONDARY | Progression-free Survival | Up to 32 months post study enrollment | months | MEDIAN | |
| SECONDARY | Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0 | 30 days post-treatment, up to 32 months | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Best Overall Response Rate | Enzalutamide | 4.3 | 95% Confidence Interval 0.5 to 14.8 | percentage of patients | |
| Progression-free Survival | Enzalutamide | 5.6 | 95% Confidence Interval 3.7 to 7.5 | months | |
| Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0 | Enzalutamide | 22 | Participants |
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 | Enzalutamide | 46 | |
| Overall Study | COMPLETED | Enzalutamide | 46 | |
| Overall Study | NOT COMPLETED | Enzalutamide | 0 |
Source ClinicalTrials.gov
Adverse events130
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 | Anemia | Blood and lymphatic system disorders | Enzalutamide | 11 | 46 | 22 |
| other | Atrial fibrillation | Cardiac disorders | Enzalutamide | 1 | 46 | 4 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Enzalutamide | 1 | 46 | 12 |
| other | Heart failure | Cardiac disorders | Enzalutamide | 1 | 46 | 2 |
| other | Ear pain | Ear and labyrinth disorders | Enzalutamide | 2 | 46 | 5 |
| other | Hearing impaired | Ear and labyrinth disorders | Enzalutamide | 1 | 46 | 4 |
| other | Tinnitus | Ear and labyrinth disorders | Enzalutamide | 1 | 46 | 1 |
| other | Blurred vision | Eye disorders | Enzalutamide | 1 | 46 | 1 |
| other | Dry eye | Eye disorders | Enzalutamide | 1 | 46 | 3 |
| other | Eye disorders - Other, specify | Eye disorders | Enzalutamide | 1 | 46 | 1 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enzalutamide | 27 | 46 |
| Total, other adverse events | Enzalutamide | 44 | 46 |
| Total, serious adverse events | Enzalutamide | 15 | 46 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35867947 | DERIVED |
Source PubMed
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/NCT02749903
GET https://conductscience.org/api/trials/v1/NCT02749903/events?page=2