Trial · NCT01879085
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
NCT01879085, Phase 1, Phase 2, Completed, Melissa Burgess, MD; results first posted 2022-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma. Trials, record NCT01879085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01879085
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
- NCT number
- NCT01879085
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Melissa Burgess, MD
- Conditions
- Sarcoma
- Interventions
- Docetaxel, Gemcitabine, Vorinostat, Pegfilgrastim
- First posted
- 2013-06-17
- Last updated
- 2022-09-21
- Results first posted
- 2022-09-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Recommended Phase II Dose of Vorinostat | During Cycle 1 of treatment | Recommended Phase ll dose of vorinostat that can be safely combined with gemcitabine and docetaxel. Gemcitabine and docetaxel were given at a fixed dose while vorinostat was dose-escalated using a standard '3+3' design. Dose-limiting toxicity (DLT) is defined as specific study drug-related events experienced during Cycle 1; only DLTs observed in a patient during the first cycle of treatment will be used for the dose escalation decision. |
| Primary | Six-month Progression-free Survival (PFS) | Up to 6 months (per patient) | Proportion of participants whose disease does not progress within 6 months of start of treatment (number of patients without progressive disease/total number of patients). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. |
| Secondary | Objective Response Rate (ORR) | Up to 7 years and 7 months | Number of patients with Complete response \[CR\] + partial response \[PR\], per RECIST v1.1 criteria . Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters |
| Secondary | Progression-free Survival (PFS) | Up to 7 years and 7 months | The median length of time from the beginning of study treatment that patients remain alive without progression of their disease (cancer). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. |
| Secondary | One-year Progression-free Survival (PFS) | Up to one year (per patient) | Proportion of participants whose disease does not progress within one year of start of treatment (number of patients with progressive disease/total number of patients). Per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. |
| Secondary | Overall Survival (OS) | Up to 7 years and 7 months | The median length of time from the start of treatment that diagnosed study participants remain alive. |
| Secondary | Six-month Overall Survival (OS) | Up to 6 months (per patient) | Proportion of participants alive at six months from the start of treatment. |
| Secondary | One-year Overall Survival (OS) | Up to one year (per patient) | Proportion of participants alive at one year from the start of treatment. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: Recommended Phase II Dose of Vorinostat | During Cycle 1 of treatment | Patients treated with combination therapy. | mg/day of Vorinostat | NUMBER |
| PRIMARY | Six-month Progression-free Survival (PFS) | Up to 6 months (per patient) | Patients that received combination therapy that were evaluable for response to treatment.~Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat. | proportion of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | Up to 7 years and 7 months | Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Up to 7 years and 7 months | Patients that received combination therapy that were evaluable for response to treatment.~Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat. | months | MEDIAN |
| SECONDARY | One-year Progression-free Survival (PFS) | Up to one year (per patient) | Patients that received combination therapy that were evaluable for response to treatment.~Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat. | proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 7 years and 7 months | Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat. | months | MEDIAN |
| SECONDARY | Six-month Overall Survival (OS) | Up to 6 months (per patient) | Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat. | proportion of participants | NUMBER |
| SECONDARY | One-year Overall Survival (OS) | Up to one year (per patient) | Patients that received combination therapy. Note: Six of the twelve patients enrolled to the Phase 1b group at Dose Level 1 / RP2D were analyzed with the Phase 2 group due to same dose level of vorinostat. | proportion of 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 |
|---|---|---|---|---|---|
| Phase I: Recommended Phase II Dose of Vorinostat | Combination Therapy: Docetaxel + Gemcitabine + Vorinostat + Pegfilgrastim | 300 | mg/day of Vorinostat | ||
| Six-month Progression-free Survival (PFS) | Phase 2 | 0.473 | 95% Confidence Interval 0.325 to 0.69 | proportion of participants | |
| Objective Response Rate (ORR) | Phase 2 | 7 | Participants | ||
| Progression-free Survival (PFS) | Phase 2 | 5.552361 | 95% Confidence Interval 2.694045 to 12.41889 | months | |
| One-year Progression-free Survival (PFS) | Phase 2 | 0.304 | 95% Confidence Interval 0.177 to 0.523 | proportion of participants | |
| Overall Survival (OS) | Phase 2 | 11.92608 | 95% Confidence Interval 10.05339 to 20.33676 | months | |
| Six-month Overall Survival (OS) | Phase 2 | 0.742 | 95% Confidence Interval 0.603 to 0.913 | proportion of participants | |
| One-year Overall Survival (OS) | Phase 2 | 0.477 | 95% Confidence Interval 0.328 to 0.692 | proportion of participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1b | STARTED | Dose Level 1 | 6 | |
| Phase 1b | STARTED | Dose Level 2 | 6 | |
| Phase 1b | STARTED | Phase 2 | 0 | |
| Phase 1b | COMPLETED | Dose Level 1 | 6 | |
| Phase 1b | COMPLETED | Dose Level 2 | 6 | |
| Phase 1b | COMPLETED | Phase 2 | 0 | |
| Phase 1b | NOT COMPLETED | Dose Level 1 | 0 | |
| Phase 1b | NOT COMPLETED | Dose Level 2 | 0 | |
| Phase 1b | NOT COMPLETED | Phase 2 | 0 | |
| Phase 2 | STARTED | Dose Level 1 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events398
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 distension | Gastrointestinal disorders | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 1 | 31 | |
| other | Abdominal distension | Gastrointestinal disorders | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 0 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 6 | 31 | |
| other | Abdominal pain | Gastrointestinal disorders | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 0 | 6 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 3 | 31 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 1 | 6 | |
| other | Alanine aminotransferase increased | Investigations | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 10 | 31 | |
| other | Alanine aminotransferase increased | Investigations | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 3 | 6 | |
| other | Alkaline phosphatase increased | Investigations | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 19 | 31 | |
| other | Alkaline phosphatase increased | Investigations | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 3 | 6 |
1 to 10 of 398Source ClinicalTrials.gov
See all 398 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 26 | 31 |
| Total, all-cause mortality | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 5 | 6 |
| Total, other adverse events | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 31 | 31 |
| Total, other adverse events | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 6 | 6 |
| Total, serious adverse events | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day | 19 | 31 |
| Total, serious adverse events | Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day | 3 | 6 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day vs Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day: deaths from any cause | Trial comparisons |
| Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 300 mg/Day vs Docetaxel + Gemcitabine + Pegfilgrastim + Vorinostat 200 mg Twice/Day: 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/NCT01879085
GET https://conductscience.org/api/trials/v1/NCT01879085/events?page=2