NCT00365053 · 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: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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

Source null

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secondary · POSTED

Estimated using the product-limit method of Kaplan and Meier.

Source null

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secondary · POSTED

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.

Source null

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secondary · POSTED

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.

Source null

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secondary · POSTED

Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.

Assay data were not collected.

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secondary · POSTED

Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.

IHC data were not collected.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-recurrent-f0c1024d
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: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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-recurrent-f0c1024d
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