Trial · NCT00128102
Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)
NCT00128102, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2020-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014). Trials, record NCT00128102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00128102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)
- NCT number
- NCT00128102
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 661 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Mesothelioma, Lung Cancer
- Interventions
- Vorinostat, Placebo
- First posted
- 2005-08-09
- Last updated
- 2020-10-26
- Results first posted
- 2020-10-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of final analysis were censored at the date of the last follow up. The final analysis for OS was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. OS analysis is reported here for all randomized participants. |
| Primary | Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. Reporting of AEs per NCI CTCAE is based on 5 grades of severity; Grade 1 (mild; no treatment needed), Grade 2 (moderate; minimal treatment needed), Grade 3 (severe, not life threatening; hospitalization needed), Grade 4 (life threatening; urgent treatment needed) and Grade 5 (death).The final analysis for Grade 3 or 4 AEs was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced Grade 3/4 AEs per NCI CTCAE is reported here for all randomized participants who received ≥1 dose of study treatment. |
| Primary | Number of Participants Who Experienced an AE | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who experienced an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced an AE is reported here for all randomized participants who received ≥1 dose of study treatment. |
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who discontinued study treatment due to an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who discontinued study treatment due to an AE is reported here for all randomized participants who received ≥1 dose of study treatment. As specified by the protocol, participants who discontinued study treatment due to an AE remained on study until investigator notification to discontinue. |
| Secondary | Progression Free Survival (PFS) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per meso-modified-Response Evaluation Criteria in Solid Tumors (Meso-modified RECIST) based on independent radiology review or death due to any cause, whichever occurred first. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. Per meso-modified RECIST, PD was defined as ≥20% increase in the total tumor measurement over the nadir measurement or the appearance of ≥1 new lesions. The final analysis for PFS per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. PFS analysis per Meso-modified RECIST by independent radiology review is reported here for all randomized participants. |
| Secondary | Objective Response Rate (ORR) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | ORR was defined as the percentage of participants in the analysis population who had a complete response (CR: disappearance of all target lesions with no evidence of tumor elsewhere) or a partial response (PR: ≥30% reduction in the total tumor measurement) per Meso-modified RECIST based on independent radiology review. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. The final analysis for ORR per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol percentage of participants who had a CR or a PR per Meso-modified RECIST by independent radiology review is reported here as the ORR for all randomized participants who had valid baseline data for ORR analysis available. |
| Secondary | Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12 | Baseline, Week 12 | LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percent change in the LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available. |
| Secondary | Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12 | Baseline, Week 12 | LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥50% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) and \>10 mm absolute change in LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available. |
| Secondary | Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 12 | Baseline, Week 12 | Pulmonary function test was conducted using a spirometer for assessment of FVC. FVC is the volume of air forcibly exhaled from the lungs after taking the deepest breath possible. Baseline measurement was taken before treatment initiation. Per protocol percent change in FVC from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for FVC available. |
| Secondary | Percentage of Participants With ≥10% Change From Baseline in FVC at Week 12 | Baseline, Week 12 | Pulmonary function test was conducted using a spirometer for assessment of FVC. FVC is the volume of air forcibly exhaled from the lungs after taking the deepest breath possible. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥10% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) in FVC from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for FVC. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | All participants randomized to a study arm. | Weeks | MEDIAN |
| PRIMARY | Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | All participants randomized to a study arm who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced an AE | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | All participants randomized to a study arm who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | All participants randomized to a study arm who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | All participants randomized to a study arm. | Weeks | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | All participants randomized to a study arm who had valid baseline data for ORR analysis available. | Percentage of Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12 | Baseline, Week 12 | All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available. | Percent Change | MEAN |
| SECONDARY | Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12 | Baseline, Week 12 | All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 12 | Baseline, Week 12 | All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for FVC available. | Percent Change | MEAN |
| SECONDARY | Percentage of Participants With ≥10% Change From Baseline in FVC at Week 12 | Baseline, Week 12 | All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for FVC available. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Vorinostat | 30.7 | 95% Confidence Interval 26.71 to 36.14 | Weeks | |
| Overall Survival (OS) | Placebo | 27.1 | 95% Confidence Interval 23.14 to 31.86 | Weeks | |
| Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | Vorinostat | 165 | Participants | ||
| Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | Placebo | 146 | Participants | ||
| Number of Participants Who Experienced an AE | Vorinostat | 327 | Participants | ||
| Number of Participants Who Experienced an AE | Placebo | 311 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Vorinostat | 60 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Placebo | 49 | Participants | ||
| Progression Free Survival (PFS) | Vorinostat | 6.3 | 95% Confidence Interval 6.1 to 7.1 | Weeks | |
| Progression Free Survival (PFS) | Placebo | 6.1 | 95% Confidence Interval 6.0 to 6.1 | Weeks |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vorinostat | 329 | |
| Overall Study | STARTED | Placebo | 332 | |
| Overall Study | Treated | Vorinostat | 329 | |
| Overall Study | Treated | Placebo | 329 | |
| Overall Study | COMPLETED | Vorinostat | 1 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Vorinostat | 328 | |
| Overall Study | NOT COMPLETED | Placebo | 332 |
Source ClinicalTrials.gov
Adverse events276
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 | Anaemia | Blood and lymphatic system disorders | Vorinostat | 45 | 329 | 86 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 22 | 329 | 24 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vorinostat | 22 | 329 | 46 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 2 | 329 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Vorinostat | 28 | 329 | 32 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 17 | 329 | 18 |
| other | Constipation | Gastrointestinal disorders | Vorinostat | 80 | 329 | 116 |
| other | Constipation | Gastrointestinal disorders | Placebo | 69 | 329 | 96 |
| other | Diarrhoea | Gastrointestinal disorders | Vorinostat | 142 | 329 | 327 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 58 | 329 | 85 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vorinostat | 288 | 329 |
| Total, all-cause mortality | Placebo | 284 | 332 |
| Total, other adverse events | Vorinostat | 303 | 329 |
| Total, other adverse events | Placebo | 281 | 329 |
| Total, serious adverse events | Vorinostat | 133 | 329 |
| Total, serious adverse events | Placebo | 131 | 329 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25800891 | RESULT |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Vorinostat vs Placebo: Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | Trial comparisons |
| Vorinostat vs Placebo: Number of Participants Who Experienced an AE | Trial comparisons |
| Vorinostat vs Placebo: Number of Participants Who Discontinued Study Treatment Due to an AE | Trial comparisons |
| Vorinostat vs Placebo: deaths from any cause | Trial comparisons |
| Vorinostat vs Placebo: serious adverse events | Trial comparisons |
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/NCT00128102
GET https://conductscience.org/api/trials/v1/NCT00128102/events?page=2