Clinical trial · Interventional
Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma
NCT00509041CI-TRIAL-00023465completedPhase 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)
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with previously treated malignant mesothelioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib
- description
- Use of dasatinib in treatment of pts with previously treated malignant mesothelioma
- interventionNames
- Drug: dasatinib
Primary outcomes (1)
- measure
- 24 Week Progression Free Survival
- timeFrame
- 24 weeks
- description
- Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Secondary outcomes (3)
- measure
- Number of Participants With Overall Tumor Response
- timeFrame
- Duration of study until progression (up to 3 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant mesothelioma of any of the following subtypes:
* Epithelial
* Sarcomatoid
* Mixed
* Any site of origin of malignant mesothelioma allowed including, but not limited to, any of the following:
* Pleura
* Peritoneum
* Pericardium
* Tunica vaginalis
* Pathology blocks or slides from a core surgical biopsy must be available
* Not amenable to curative surgery
* Measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (CT scan , MRI, or x-ray) or as ≥ 10 mm with spiral CT scan
* Patients with pleural rind only disease must have at least one level with one rind measurement ≥ 1.5 cm
* Lesions that are considered nonmeasurable include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Prior treatment with one and only one systemic chemotherapy regimen, which must have included pemetrexed disodium required
* Treatment may have been with pemetrexed disodium alone or in combination with any other agent
* No symptomatic pleural effusions, unless the patient undergoes a therapeutic thoracentesis
* Patients with pleural effusions who have had a pleurodesis are eligible
* No known brain metastases
* May be registered on CALGB-150707 companion study
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Granulocytes ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Total bilirubin ≤ 2 x upper limit of normal (ULN)
* AST (SGOT) ≤ 2.5 x ULN
* Creatinine clearance ≥ 60 mL/min
* INR \< 1.5
* PTT \< 40 seconds
* QTc \< 450 msec
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No significant cardiac disease, including any of the following:
* New York Heart Association (NYHA) class III-IV congestive heart failure (CHF)
* Unstable angina
* Myocardial infarction or ventricular tachyarrhythmia within 6 months of study entry
* Ejection fraction less than institutional normal (in patients with a history of CHF or currently with NYHA class I or II CHF)
* Prolonged QTc \> 450 msec (Fridericia correction)
* Major conduction abnormality, unless a cardiac pacemaker is present
* Hypokalemia or hypomagnesemia that cannot be corrected
* No history of significant bleeding disorder unrelated to cancer, including any of the following:
* Congenital bleeding disorder (e.g., von Willebrand disease)
* Acquired bleeding disorder within the past year (e.g., acquired anti-factor VIII antibodies)
* Ongoing or recent (≤ 3 months) significant GI bleeding or hemoptysis
* No requirement for supplemental oxygen (i.e., pulse oximetry \< 89% at rest)
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior pemetrexed disodium-containing chemotherapy
* At least 4 weeks since prior major surgery
* At least 4 weeks since prior radiation therapy
* Measurable disease must be outside the radiation port
* Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
* Intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy
* At least 7 days since prior and no concurrent antithrombotic or anti-platelet agents, including any of the following:
* Aspirin or aspirin-containing combinations
* Clopidogrel
* Dipyridamole
* Tirofiban
* Epoprostenol
* Eptifibatide
* Cilostazol
* Abciximab
* Ticlopidine
* Warfarin
* Low-dose warfarin for prophylaxis to prevent catheter thrombosis allowed
* Heparin or low molecular weight heparin
* Heparin for IV line flush allowed
* At least 7 days since prior and no concurrent use of the following drugs:
* Itraconazole
* Ketoconazole (at doses \> 200 mg/day)
* Miconazole
* Voriconazole
* Telithromycin
* Primidone
* Rifabutin
* Rifampin
* St. John's wort
* Carbamazepine
* Oxcarbazepine
* Rifapentine
* Phenobarbital
* Phenytoin
* Quinidine
* Procainamide
* Disopyramide
* Amiodarone
* Sotalol
* Ibutilide
* Dofetilide
* Erythromycin
* Clarithromycin
* Chlorpromazine
* Haloperidol
* Mesoridazine
* Thioridazine
* Pimozide
* Bepridil
* Droperidol
* Halofantrine
* Levomethadyl
* Sparfloxacin
* No concurrent H2 blockers or proton pump inhibitors
* No bisphosphonate therapy during the first 8 weeks of study treatment
* No concurrent hormones or other chemotherapeutic agents except for steroids administered for dasatinib-related pleural effusion or hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
* No concurrent palliative radiation therapyReferences
Publications (1)
- RESULTDudek A, Pang H, Kratzke RA, et al.: CALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM). [Abstract] J Clin Oncol 28 (Suppl 15) A-7037, 2010.