TriangleNCT00365053 · STUDY IN CONTEXT
PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
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
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Estimated using the product-limit method of Kaplan and Meier.
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
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-malignant-mesothelioma
- nct id
- NCT00365053
- trial label
- PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
- 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-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0000
- source section id
- NCT00365053-om-0000
- source outcome index
- 0
- endpoint
- Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
- endpoint definition
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- time origin
- Up to 3 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-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0001
- source section id
- NCT00365053-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Estimated using the product-limit method of Kaplan and Meier.
- time origin
- Up to 3 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-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0002
- source section id
- NCT00365053-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- time origin
- Up to 3 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-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0003
- source section id
- NCT00365053-om-0003
- source outcome index
- 3
- endpoint
- Toxicity Profile
- endpoint definition
- Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
- time origin
- Up to 3 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-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0004
- source section id
- NCT00365053-om-0004
- source outcome index
- 4
- endpoint
- Apoptosis by TUNEL Assay
- endpoint definition
- Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
- time origin
- At baseline
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Assay data were not collected.
- 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-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0005
- source section id
- NCT00365053-om-0005
- source outcome index
- 5
- endpoint
- Histone Acetylation by IHC and Western Blotting
- endpoint definition
- Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.
- time origin
- At baseline and at 4 hours after last dose of PXD101 on day 5
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- IHC 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-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Belinostat)
- regimen
- Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00365053-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Belinostat)
- regimen
- Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00365053-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Belinostat)
- regimen
- Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00365053-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Belinostat)
- regimen
- Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00365053-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Belinostat)
- regimen
- Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00365053-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00365053
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Belinostat)
- regimen
- Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00365053-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT00365053
- harm key
- EG000
- source section id
- NCT00365053-ae
- event group key
- EG000
- event group label
- Treatment (Belinostat)
- serious affected
- 3
- serious at risk
- 13
- other affected
- 13
- other at risk
- 13
- frequency threshold
- 0
- collection period
- Adverse events were collected over a period of 1 year, 1 month.
- event definition
- "Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.
- 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