Trial · NCT00301756
Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors
NCT00301756, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors. Trials, record NCT00301756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00301756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors
- NCT number
- NCT00301756
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor, Recurrent Ovarian Carcinoma, Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor, Stage III Ovarian Cancer, Stage IV Borderline Ovarian Surface Epithelial-Stromal Tumor, Stage IV Ovarian Cancer
- Interventions
- Belinostat, Laboratory Biomarker Analysis
- First posted
- 2006-03-13
- Last updated
- 2018-08-20
- Results first posted
- 2016-12-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD | Up to 5 years | Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria. |
| Secondary | Time to Disease Progression (Epithelial Ovarian Cancer Group) | Up to 5 years | Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion. |
| Secondary | Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group) | Up to 5 years | Stable disease rate, defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive disease, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria. |
| Secondary | Duration of Response | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | Summarized using summary statistics, such as the mean, median, counts and proportion. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots. |
| Secondary | Progression-free Survival | Duration of time from start of treatment to time of progression, assessed up to 5 years | Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots. |
| Secondary | Overall Survival | Up to 5 years | Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots. |
| Secondary | Number of Grade 3 Adverse Events Using the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Up to 5 years | Events of Thrombosis, Hypersensitivity and ALP will be tabulated. |
| Secondary | Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group) | Up to 5 years | Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion. |
| Secondary | Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group) | Up to 5 years | Stable disease rate, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria. |
| Other | Relationship Between Clinical and Pharmacodynamic Effects of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors | Up to 5 years | Summarized using summary statistics, such as the mean, median, and range. Tested using one-sample t-tests or Wilcoxon rank sum tests. Logistic regression analysis will be used to test significance. |
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 | Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD | Up to 5 years | participants | NUMBER | |
| SECONDARY | Time to Disease Progression (Epithelial Ovarian Cancer Group) | Up to 5 years | Eighteen patients with Epethelial Ovarian Cancer were analyzed | months | MEDIAN |
| SECONDARY | Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group) | Up to 5 years | 14 patients with Low Malignant Potential tumours or Micropapillary / borderline were analyzed | participants | NUMBER |
| SECONDARY | Duration of Response | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | No participants had an objective response out of the 32 patients analyzed. | ||
| SECONDARY | Progression-free Survival | Duration of time from start of treatment to time of progression, assessed up to 5 years | months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 5 years | Data were not collected | ||
| SECONDARY | Number of Grade 3 Adverse Events Using the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Up to 5 years | 18 patients with Epithelial ovarian cancer (EOC) and 14 patients with Micro-papillary ovarian tumor (LMP) | events | NUMBER |
| SECONDARY | Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group) | Up to 5 years | months | MEDIAN | |
| SECONDARY | Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group) | Up to 5 years | 18 patients from Epithelian Ovarian Cancer patients were analyzed | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Relationship Between Clinical and Pharmacodynamic Effects of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors | Up to 5 years |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD | Treatment (Enzyme Inhibitor Therapy) | 0 | participants | ||
| Time to Disease Progression (Epithelial Ovarian Cancer Group) | Treatment (Enzyme Inhibitor Therapy) | 2.3 | 95% Confidence Interval 1.2 to 5.7 | months | |
Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group) | Treatment (Enzyme Inhibitor Therapy) | 10 | participants | ||
| Progression-free Survival | Treatment (Enzyme Inhibitor Therapy) | 13.4 | 95% Confidence Interval 5.6 to NA | months | |
| Number of Grade 3 Adverse Events Using the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Treatment (Belinostat / Enzyme Inhibitor Therapy) | 5 | events | ||
| Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group) | Treatment (Enzyme Inhibitor Therapy) | 13.4 | 95% Confidence Interval 5.6 to NA | months | |
Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group) | Treatment (Enzyme Inhibitor Therapy) | 9 | 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 | Treatment (Belinostat / Enzyme Inhibitor Therapy) | 32 | |
| Overall Study | COMPLETED | Treatment (Belinostat / Enzyme Inhibitor Therapy) | 32 | |
| Overall Study | NOT COMPLETED | Treatment (Belinostat / Enzyme Inhibitor Therapy) | 0 |
Source ClinicalTrials.gov
Adverse events22
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 | Fatigue | General disorders | Treatment (Enzyme Inhibitor Therapy) | 28 | 32 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 26 | 32 | |
| other | Lymphocyte count decreased | Investigations | Treatment (Enzyme Inhibitor Therapy) | 24 | 32 | |
| other | Constipation | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 23 | 32 | |
| serious | Pneumonitis | Respiratory, thoracic and mediastinal disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 32 | |
| serious | Fatigue | General disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 32 | |
| serious | Small intestinal obstruction | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 3 | 32 | |
| serious | Constipation | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 2 | 32 | |
| serious | Cytokine release syndrome | Immune system disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 32 | |
| serious | Small intestinal obstruction | Gastrointestinal disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 32 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Enzyme Inhibitor Therapy) | ||
| Total, other adverse events | Treatment (Enzyme Inhibitor Therapy) | 32 | 32 |
| Total, serious adverse events | Treatment (Enzyme Inhibitor Therapy) | 12 | 32 |
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 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/NCT00301756
GET https://conductscience.org/api/trials/v1/NCT00301756/events?page=2