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History of Changes for Study: NCT00509041
Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
Latest version (submitted July 11, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 30, 2007 None (earliest Version on record)
2 August 24, 2007 Study Status
3 September 27, 2007 Study Status and Study Description
4 October 13, 2007 Recruitment Status, Study Status and Contacts/Locations
5 October 19, 2007 Arms and Interventions and Study Status
6 October 25, 2007 Arms and Interventions and Study Status
7 November 6, 2007 Arms and Interventions and Study Status
8 November 14, 2007 Study Status
9 November 15, 2007 Study Status and Contacts/Locations
10 November 22, 2007 Contacts/Locations and Study Status
11 December 1, 2007 Contacts/Locations and Study Status
12 December 8, 2007 Study Status and Contacts/Locations
13 December 25, 2007 Study Status
14 January 4, 2008 Study Status and Contacts/Locations
15 January 9, 2008 Contacts/Locations and Study Status
16 January 19, 2008 Contacts/Locations and Study Status
17 February 1, 2008 Contacts/Locations and Study Status
18 February 6, 2008 Study Status and Contacts/Locations
19 February 9, 2008 Contacts/Locations and Study Status
20 April 9, 2008 Study Status
21 April 25, 2008 Study Status
22 May 13, 2008 Study Status
23 May 18, 2008 Study Status and Contacts/Locations
24 May 24, 2008 Contacts/Locations, Arms and Interventions and Study Status
25 July 16, 2008 Study Status and Contacts/Locations
26 July 18, 2008 Contacts/Locations and Study Status
27 July 23, 2008 Study Design and Study Status
28 August 13, 2008 Study Status and Contacts/Locations
29 August 23, 2008 Contacts/Locations and Study Status
30 August 27, 2008 Contacts/Locations and Study Status
31 October 22, 2008 Study Status
32 October 23, 2008 Study Status and Contacts/Locations
33 October 25, 2008 Contacts/Locations and Study Status
34 October 28, 2008 Contacts/Locations and Study Status
35 November 7, 2008 Study Status
36 November 11, 2008 Contacts/Locations and Study Status
37 November 13, 2008 Contacts/Locations and Study Status
38 November 14, 2008 Contacts/Locations and Study Status
39 November 19, 2008 Contacts/Locations and Study Status
40 November 26, 2008 Contacts/Locations and Study Status
41 December 13, 2008 Study Status and Contacts/Locations
42 December 17, 2008 Contacts/Locations and Study Status
43 December 23, 2008 Contacts/Locations and Study Status
44 December 25, 2008 Contacts/Locations and Study Status
45 December 31, 2008 Contacts/Locations and Study Status
46 January 6, 2009 Contacts/Locations and Study Status
47 January 15, 2009 Contacts/Locations and Study Status
48 January 24, 2009 Contacts/Locations and Study Status
49 February 6, 2009 Arms and Interventions and Study Status
50 February 10, 2009 Study Status and Contacts/Locations
51 March 7, 2009 Eligibility and Study Status
52 March 27, 2009 Contacts/Locations and Study Status
53 April 14, 2009 Sponsor/Collaborators and Study Status
54 May 5, 2009 Study Status and Contacts/Locations
55 May 14, 2009 Contacts/Locations and Study Status
56 July 4, 2009 Study Status and Contacts/Locations
57 August 11, 2009 Study Status and Contacts/Locations
58 September 22, 2009 Recruitment Status, Study Status and Contacts/Locations
59 April 24, 2010 Sponsor/Collaborators and Study Status
60 July 10, 2010 References and Study Status
61 June 21, 2011 Outcome Measures, Study Status, Arms and Interventions, Study Design, Study Identification, Eligibility, Study Description and Oversight
62 December 11, 2012 Recruitment Status, Study Status, Outcome Measures, Sponsor/Collaborators, Results and Study Design
63 April 29, 2013 Study Identification, Study Status, Adverse Events, Outcome Measures, Baseline Characteristics and Participant Flow
64 July 11, 2016 Sponsor/Collaborators, Study Status, Study Identification and Baseline Characteristics
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Study NCT00509041
Submitted Date:  July 30, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000558362
Brief Title: Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma
Official Title: A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma
Secondary IDs: CALGB-30601
Open or close this module Study Status
Record Verification: July 2007
Overall Status: Not yet recruiting
Study Start: June 2007
Primary Completion:
Study Completion:
First Submitted: July 30, 2007
First Submitted that
Met QC Criteria:
July 30, 2007
First Posted: July 31, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 30, 2007
Last Update Posted: July 31, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Cancer and Leukemia Group B
Responsible Party:
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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.

Detailed Description:

OBJECTIVES:

Primary

  • To determine the rate of progression-free survival (PFS) at 24 weeks (or 5.5 months) in patients with malignant mesothelioma treated with dasatinib.

Secondary

  • To determine the response rate (partial response [PR] and complete response [CR]) in patients with malignant mesothelioma treated with dasatinib.
  • To determine the response duration in patients with malignant mesothelioma treated with dasatinib.
  • To describe the overall survival (OS) of patients with malignant mesothelioma treated with dasatinib.
  • To describe the toxicity profile of dasatinib in patients with malignant mesothelioma.
  • To determine whether the amount of expression of EphA2 and PDGFRβ, as measured by immunohistochemistry from tumor specimens, correlates with PFS in patients with malignant mesothelioma.
  • To determine whether plasma levels of VEGF and PDGFRβ, serum levels of CSF-1, and soluble mesothelin-related protein correlate with PFS in patients with malignant mesothelioma.
  • To determine whether inhibition of Src phosphorylation in PBMC correlates with PFS.
  • To assess inhibition of phosphorylation of Src, EphA2, and PDGFRβ in tumor tissue by dasatinib.

OUTLINE: Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Tumor tissue samples are analyzed for EphA2 and PDGFRβ expression by immunohistochemistry. Tumor tissue samples may also be analyzed for phosphorylation of Src, EphA2, and PDGFRβ by western blot. Blood samples are analyzed for concentration of VEGF and PDGF by quantitative sandwich enzyme immunoassay technique; mesothelin-related protein level by Mesomark® assay; CSF-1 level by ELISA assay; and phosphorylation of Src by phospho-Src (pTyr418) human ELISA.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL:

Open or close this module Conditions
Conditions: Malignant Mesothelioma
Keywords: advanced malignant mesothelioma
epithelial mesothelioma
recurrent malignant mesothelioma
sarcomatous mesothelioma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model:
Number of Arms:
Masking: None (Open Label)
Enrollment: 42
Open or close this module Arms and Interventions
Intervention Details:
Drug: dasatinib
Procedure: biological markers
Procedure: diagnostic test
Procedure: enzyme inhibitor therapy
Procedure: immunoenzyme techniques
Procedure: immunohistochemistry
Procedure: protein tyrosine kinase inhibitor therapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival (PFS) at 24 weeks (or 5.5 months)
Secondary Outcome Measures:
1. Response rate (complete and partial response) as measured by RECIST criteria
2. Response duration
3. Overall survival
4. Toxicity profile
5. Correlation of expression levels of EphA2 and PDGFRβ with response, PFS, and overall survival
6. Correlation of plasma levels of VEGF and PDGFRβ, serum levels of CSF-1, and soluble mesothelin-related protein with response, PFS, and overall survival
7. Correlation of a decrease in Src phosphorylation in PBMC with response, PFS, and overall survival
8. Correlation of a decrease in the phosphorylation of Src, EphA2, and PDGFRβ in tumor tissue with response
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
  • Must 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
  • No prior tyrosine kinase, signal transduction, or angiogenesis inhibitor therapy
  • 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 therapy
Open or close this module Contacts/Locations
Study Officials: Arkadiusz Dudek, MD
Study Chair
Masonic Cancer Center, University of Minnesota
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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