TriangleNCT00301756 · STUDY IN CONTEXT
Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.
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.
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.
Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- trial label
- Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0000
- source section id
- NCT00301756-om-0000
- source outcome index
- 0
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- Up to 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0001
- source section id
- NCT00301756-om-0001
- source outcome index
- 1
- endpoint
- Time to Disease Progression (Epithelial Ovarian Cancer Group)
- endpoint definition
- Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eighteen patients with Epethelial Ovarian Cancer were analyzed
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0002
- source section id
- NCT00301756-om-0002
- source outcome index
- 2
- endpoint
- 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)
- endpoint definition
- 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.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 14 patients with Low Malignant Potential tumours or Micropapillary / borderline were analyzed
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0003
- source section id
- NCT00301756-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response
- endpoint definition
- 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.
- time origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No participants had an objective response out of the 32 patients analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0004
- source section id
- NCT00301756-om-0004
- source outcome index
- 4
- endpoint
- Progression-free Survival
- endpoint definition
- Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
- time origin
- Duration of time from start of treatment to time of progression, assessed up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0005
- source section id
- NCT00301756-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival
- endpoint definition
- Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data were not collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Enzyme Inhibitor Therapy)
- regimen
- Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00301756-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Enzyme Inhibitor Therapy)
- regimen
- Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. belinostat: Given IV
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00301756-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Enzyme Inhibitor Therapy)
- regimen
- Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. belinostat: Given IV
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00301756-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Enzyme Inhibitor Therapy)
- regimen
- Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. belinostat: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00301756-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Enzyme Inhibitor Therapy)
- regimen
- Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. belinostat: Given IV
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00301756-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Enzyme Inhibitor Therapy)
- regimen
- Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. belinostat: Given IV
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00301756-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00301756
- harm key
- EG000
- source section id
- NCT00301756-ae
- event group key
- EG000
- event group label
- Treatment (Enzyme Inhibitor Therapy)
- serious affected
- 12
- serious at risk
- 32
- other affected
- 32
- other at risk
- 32
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice