Trial · NCT01175980
Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma
NCT01175980, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-08-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma. Trials, record NCT01175980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01175980
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorinostat in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma
- NCT number
- NCT01175980
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Oral Cavity Adenoid Cystic Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Adenoid Cystic Carcinoma, Stage III Major Salivary Gland Cancer AJCC v7, Stage III Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7, Stage IVA Major Salivary Gland Cancer AJCC v7, Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7, Stage IVB Major Salivary Gland Cancer AJCC v7, Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7, Stage IVC Major Salivary Gland Cancer AJCC v7, Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7, Tongue Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Vorinostat
- First posted
- 2010-08-05
- Last updated
- 2020-08-03
- Results first posted
- 2020-08-03
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response According to RECIST 1.1 Criteria | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Objective (Best) response according to RECIST 1.1 criteria. |
| Secondary | Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Toxicity will be tabulated via frequency distributions, and also dichotomized to report the proportion (and percentage) of patients experiencing a specified level (e.g., grade 3-4) of toxicity. |
| Secondary | Time to Recurrence (TTR) | From the start of the treatment until the RECIST measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded, assessed up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | TTR will be summarized descriptively, reporting N, median, mean, standard deviation, standard error (SE), minimum, maximum, and 90% CI for the mean calculated from the SE and asymptotic normal distribution theory. |
| Secondary | Response Duration (RD) | From the time measurement criteria are met for CR or PR (whichever is first) until the first date that recurrence or progression is objectively documented, assessed up to 60 months after the last dose of vorinostat max. treatment duration= 24 months | Median point estimate and full range will be documented, since only two patients achieved a response. |
| Secondary | Progression-free Survival (PFS) | From start of treatment to time of progression or death, whichever occurs first, assessed up to 60 months after the last dose of vorinostat maximum treatment duration= 24 months | Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both median point estimate and 90% confidence interval (CI) estimate. |
| Secondary | Overall Survival (OS) | From the start of treatment until death from any cause, duration for reported probability= 1 year; survival data collected for up to a total of 60 months | Distribution will be estimated using standard survival analysis techniques, and the K-M method. From the K-M life tables, both point and 90% CI estimates of various statistics of interest can be calculated (e.g., median, 6-month event-free rate, 12-month event-free rate, etc.). Statistical graphs of each K-M curve (with 90% CI lines) will be generated for visual display. (One year survival rate will be given since OS median was not reached due to too few events) |
| Other | Metabolic Response by PET/CT Scan | Up to 56 days | Will assess the association between a metabolic response by PET/CT after one course of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria. Will also assess the association between a metabolic response by PET/CT after the first and second chemotherapy courses and PFS. |
| Other | Number of Patients With Flow Sort Diploid Populations of Tumor Cells From FFPE Tissue Blocks | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Number of patients with Flow sort diploid populations of tumor cells from FFPE tissue blocks reported as a count of participants. |
| Other | Number of Patients With Flow Sort Aneuploid Populations of Tumor Cells From FFPE Tissue | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Number of patients with Flow sort aneuploid populations of tumor cells from FFPE tissue. Reported as descriptive results. |
| Other | Number of Patients With Flow Sort Tetraploid Populations of Tumor Cells From FFPE Tissue | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Number of patients with Flow sort tetraploid populations of tumor cells from FFPE tissue. Reported as descriptive results. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response According to RECIST 1.1 Criteria | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Recurrence (TTR) | From the start of the treatment until the RECIST measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded, assessed up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | Only 2 patients achieved a response. | months | MEAN |
| SECONDARY | Response Duration (RD) | From the time measurement criteria are met for CR or PR (whichever is first) until the first date that recurrence or progression is objectively documented, assessed up to 60 months after the last dose of vorinostat max. treatment duration= 24 months | Only 2 patients achieved a response. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From start of treatment to time of progression or death, whichever occurs first, assessed up to 60 months after the last dose of vorinostat maximum treatment duration= 24 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | From the start of treatment until death from any cause, duration for reported probability= 1 year; survival data collected for up to a total of 60 months | percentage of participants surviving 1yr | NUMBER | |
| OTHER_PRE_SPECIFIED | Metabolic Response by PET/CT Scan | Up to 56 days | We did not have funding to incorporate other imaging modalities, (such as PET/CT), or to utilize other measurement criteria (such as volumetric assessment). Therefore, these data were not collected | ||
| OTHER_PRE_SPECIFIED | Number of Patients With Flow Sort Diploid Populations of Tumor Cells From FFPE Tissue Blocks | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | the two cases that had FFPE blocks for the study | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With Flow Sort Aneuploid Populations of Tumor Cells From FFPE Tissue | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | The two cases that had FFPE blocks for the study. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With Flow Sort Tetraploid Populations of Tumor Cells From FFPE Tissue | Up to 180 days after the last dose of vorinostat maximum treatment duration= 24 months | The two cases that had FFPE blocks for the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response According to RECIST 1.1 Criteria | Treatment (Vorinostat) | Partial Response | 2 | Participants | |
| Objective Response According to RECIST 1.1 Criteria | Treatment (Vorinostat) | Stable Disease | 27 | Participants | |
| Objective Response According to RECIST 1.1 Criteria | Treatment (Vorinostat) | Progressive Disease | 1 | Participants | |
| Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Vorinostat) | Appendicitis | 1 | Participants | |
| Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Vorinostat) | Atelectasis | 1 | Participants | |
| Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Vorinostat) | Bronchial obstruction | 1 | Participants | |
| Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Vorinostat) | Bronchopulmonary hemorrhage | 1 | Participants | |
| Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Vorinostat) | Cataract | 1 | Participants | |
| Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Vorinostat) | Diarrhea | 1 | Participants | |
| Number of Participants With Grade 3 or Grade 4 Toxicity as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Vorinostat) | Fatigue | 3 | Participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Vorinostat) | 30 | |
| Overall Study | COMPLETED | Treatment (Vorinostat) | 30 | |
| Overall Study | NOT COMPLETED | Treatment (Vorinostat) | 0 |
Source ClinicalTrials.gov
Adverse events194
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 | Abdominal pain | General disorders | Treatment (Vorinostat) | 9 | 30 | 24 |
| other | Abducens nerve disorder | Nervous system disorders | Treatment (Vorinostat) | 1 | 30 | 22 |
| other | Activated partial thromboplastin time prolonged | Blood and lymphatic system disorders | Treatment (Vorinostat) | 3 | 30 | 5 |
| other | Acute kidney injury | Renal and urinary disorders | Treatment (Vorinostat) | 1 | 30 | 3 |
| other | Alanine aminotransferase increased | Hepatobiliary disorders | Treatment (Vorinostat) | 11 | 30 | 41 |
| other | Alkaline phosphatase increased | Hepatobiliary disorders | Treatment (Vorinostat) | 7 | 30 | 44 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Vorinostat) | 1 | 30 | 1 |
| other | Alopecia | General disorders | Treatment (Vorinostat) | 17 | 30 | 131 |
| other | Amnesia | Nervous system disorders | Treatment (Vorinostat) | 1 | 30 | 1 |
| other | Anal pain | Gastrointestinal disorders | Treatment (Vorinostat) | 1 | 30 | 7 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Vorinostat) | 3 | 30 |
| Total, other adverse events | Treatment (Vorinostat) | 30 | 30 |
| Total, serious adverse events | Treatment (Vorinostat) | 20 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants5
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U01CA062487 | Early Clinical Trials of New Anti-Cancer Agents | LORUSSO, PATRICIA M. | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA062502 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | DOWLATI, AFSHIN | CASE WESTERN RESERVE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA062505 | Phase I Molecular and Clincal Pharmacodynamic Trials | NEWMAN, EDWARD M | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA132123 | Princess Margaret Hospital Phase I Consortium | SIU, LILLIAN L | UNIVERSITY HEALTH NETWORK | NATIONAL CANCER INSTITUTE | 2008 to 2013 | NIH RePORTER |
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/NCT01175980
GET https://conductscience.org/api/trials/v1/NCT01175980/results?page=2