Clinical trial · Interventional
PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
Phase II Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients With Malignant Pleural Mesothelioma
NCT00365053CI-TRIAL-00033245completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Epithelial Mesothelioma | Epithelioid Mesothelioma | ALIAS | 0.90 |
| Recurrent Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Sarcomatous Mesothelioma | Pleural Solitary Fibrous Tumor | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| belinostat | Drug | Belinostat | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (belinostat)
- description
- 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.
- interventionNames
- Drug: belinostat
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
- timeFrame
- Up to 3 years
- description
- 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
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed malignant pleural mesothelioma (MPM) of any of the following subtypes: * Epithelial * Sarcomatoid * Mixed * Have received only 1 prior systemic chemotherapy regimen for advanced mesothelioma * Prior intrapleural cytotoxic agents (including bleomycin) not considered systemic chemotherapy * Patients who are not candidates for combination chemotherapy are eligible even if they have not received prior chemotherapy * Unresectable disease * Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan * The sole site of measurable disease must not be located within the radiotherapy port * No known brain metastases * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 3 months * WBC \>= 3,000/mm\^3 * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Bilirubin normal * AST/ALT =\< 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance \>= 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-barrier contraception for 1 week before, during, and for \>= 2 weeks after completion of study treatment * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101 * No symptomatic congestive heart failure * No congestive heart failure related to primary cardiac disease * No unstable angina pectoris * No cardiac arrhythmia * No condition requiring anti-arrhythmic therapy * No uncontrolled hypertension * No myocardial infarction within the past 6 months * No ischemic or severe valvular heart disease * No ongoing or active infection * No marked baseline prolongation of QT/QTc interval * No repeated QTc interval \> 500 msec * No long QT syndrome * No other significant cardiovascular disease * No other uncontrolled intercurrent illness * No psychiatric illness or social situation that would preclude study compliance * Recovered from prior therapy * No prior valproic acid or other known histone deacetylase (HDAC) inhibitor * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * More than 3 weeks since prior radiation therapy * No concurrent medication that may cause torsade de pointes * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer agents or therapies
References
Publications (0)
Data not yet available
No reference posted for this study.