Trial · NCT00473889
A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)
NCT00473889, Phase 2, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2009-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056). Trials, record NCT00473889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00473889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)
- NCT number
- NCT00473889
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 253 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Stage IIIB or IV Non-Small Cell Lung Cancer
- Interventions
- vorinostat, Comparator: paclitaxel, Comparator: carboplatin, Comparator: placebo
- First posted
- 2007-05-16
- Last updated
- 2015-07-03
- Results first posted
- 2009-10-12
- Limitations and caveats
The study was stopped following a pre-planned interim analysis because the goal for this study to continue was not met, based on 100 events, a reduction in the hazard ratio for progression-free survival by \> 23% with a one-sided p-value \< 0.1
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Start of treatment to death | Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up. |
| Secondary | Progression Free Survival | Start of treatment to disease progression or death | Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions. |
| Secondary | Number of Participants Who Had a Disease Response to Treatment | Every 42 days from start of treatment until disease response | Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions). |
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 | Overall Survival | Start of treatment to death | Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized. | Months | MEDIAN |
| SECONDARY | Progression Free Survival | Start of treatment to disease progression or death | Full analysis set~(FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Had a Disease Response to Treatment | Every 42 days from start of treatment until disease response | Full analysis set~(FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Vorinostat + Paclitaxel + Carboplatin | 11.0 | Full Range 0.2 to 17.3 | Months | |
| Overall Survival | Placebo + Paclitaxel + Carboplatin | 14.0 | Full Range 0.03 to 18.7 | Months | |
| Progression Free Survival | Vorinostat + Paclitaxel + Carboplatin | 4.3 | Full Range 0.03 to 13.4 | Months | |
| Progression Free Survival | Placebo + Paclitaxel + Carboplatin | 5.5 | Full Range 0.03 to 13.8 | Months | |
| Number of Participants Who Had a Disease Response to Treatment | Vorinostat + Paclitaxel + Carboplatin | Responder | 28 | Participants | |
| Number of Participants Who Had a Disease Response to Treatment | Placebo + Paclitaxel + Carboplatin | Responder | 36 | Participants | |
| Number of Participants Who Had a Disease Response to Treatment | Vorinostat + Paclitaxel + Carboplatin | Non-Responder | 97 | Participants | |
| Number of Participants Who Had a Disease Response to Treatment | Placebo + Paclitaxel + Carboplatin | Non-Responder | 87 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vorinostat + Paclitaxel + Carboplatin | 126 | |
| Overall Study | STARTED | Placebo + Paclitaxel + Carboplatin | 127 | |
| Overall Study | COMPLETED | Vorinostat + Paclitaxel + Carboplatin | 43 | |
| Overall Study | COMPLETED | Placebo + Paclitaxel + Carboplatin | 63 | |
| Overall Study | NOT COMPLETED | Vorinostat + Paclitaxel + Carboplatin | 83 | |
| Overall Study | NOT COMPLETED | Placebo + Paclitaxel + Carboplatin | 64 |
Source ClinicalTrials.gov
Adverse events314
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 + Paclitaxel + Carboplatin | 51 | 124 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Paclitaxel + Carboplatin | 42 | 124 | |
| other | Leukopenia | Blood and lymphatic system disorders | Vorinostat + Paclitaxel + Carboplatin | 13 | 124 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Paclitaxel + Carboplatin | 18 | 124 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Vorinostat + Paclitaxel + Carboplatin | 9 | 124 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + Paclitaxel + Carboplatin | 10 | 124 | |
| other | Neutropenia | Blood and lymphatic system disorders | Vorinostat + Paclitaxel + Carboplatin | 53 | 124 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Paclitaxel + Carboplatin | 55 | 124 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vorinostat + Paclitaxel + Carboplatin | 45 | 124 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Paclitaxel + Carboplatin | 23 | 124 |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vorinostat + Paclitaxel + Carboplatin | ||
| Total, all-cause mortality | Placebo + Paclitaxel + Carboplatin | ||
| Total, other adverse events | Vorinostat + Paclitaxel + Carboplatin | 114 | 124 |
| Total, other adverse events | Placebo + Paclitaxel + Carboplatin | 117 | 124 |
| Total, serious adverse events | Vorinostat + Paclitaxel + Carboplatin | 63 | 124 |
| Total, serious adverse events | Placebo + Paclitaxel + Carboplatin | 45 | 124 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26521238 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vorinostat + Paclitaxel + Carboplatin vs Placebo + Paclitaxel + Carboplatin: serious adverse events |
Source 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/NCT00473889
GET https://conductscience.org/api/trials/v1/NCT00473889/events?page=2