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Sorafenib in Previously Treated Malignant Mesothelioma (SMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00794859
Recruitment Status : Unknown
Verified August 2009 by King's College London.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2008
Last Update Posted : August 4, 2009
Information provided by:
King's College London

Brief Summary:
The principal objective of the study is to investigate the effect of sorafenib on progression free survival (time until the cancer begins to grow again,) in patients with malignant mesothelioma who have had prior treatment with chemotherapy. Effectiveness of the drug will also be explored with PET scans before and during treatment.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Sorafenib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of Sorafenib in Malignant Mesothelioma Previously Treated With Platinum-based Chemotherapy
Study Start Date : October 2008
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Intervention Details:
  • Drug: Sorafenib
    400mg twice daily

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Response rate as assessed with CT scan [ Time Frame: 2 months ]
  2. Overall survival [ Time Frame: Median ]
  3. Change in FDG-PET avidity [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Malignant pleural or peritoneal mesothelioma previously treated with first line platinum-based chemotherapy (prior pemetrexed not required)
  • Not suitable for radical resection. Prior radical or cytoreductive surgery allowed
  • Age >18 years
  • ECOG performance status 0-2
  • Measurable disease. Lesions must be measured by CT scan or MRI according to modified RECIST (Appendix B)
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:

    • haemoglobin ≥ 9.0 g/dL
    • neutrophil count ≥ 1.5 x109/L
    • platelet count ≥ 100 x109/L
    • total bilirubin ≤ 1.5 x upper limit of normal
    • ALT and AST ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for *alkaline phosphatase ≤ 4 x upper limit of normal
    • PT-INR (international normalized ratio of PT) / PTT ≤1.5 x upper limit of normal
  • Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.

Exclusion Criteria:

  • History of cardiac disease: congestive heart failure > NYHA (New York Heart Association) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); or uncontrolled hypertension (defined as systolic blood pressure >150mmHg or diastolic pressure >90mmHg despite optimal medical management)
  • Impaired immunity or chronic infection including history of HIV (human immunodeficiency virus) infection or chronic hepatitis B or C
  • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
  • Seizure disorder requiring medication (such as steroids or anti-epileptics)
  • Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
  • History of organ allograft
  • Evidence or history of bleeding diathesis or coagulopathy;
  • Renal dialysis
  • Cancer other than mesothelioma within 5 years prior to start of study treatment EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumours [Ta (noninvasive tumour), Tis (carcinoma in situ) & T1 (tumour invading lamina propria)]
  • Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
  • Pulmonary haemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
  • Any other haemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
  • Serious, non-healing wound, ulcer, or bone fracture
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or could jeopardise the safety of the patient and their compliance in the study
  • Patients unable to swallow oral medications
  • Any malabsorption condition.
  • Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for malignant mesothelioma, other than first line platinum-based combination chemotherapy
  • Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section)
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug (bronchoscopy is allowed)
  • Granulocyte colony stimulating factor (GCSF) or granulocyte macrophage colony stimulating factor (GMCSF), within 3 weeks of study entry
  • Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin (1 mg po OD) is permitted if the INR (international normalized ratio) is < 1.5. Low-dose aspirin is permitted (≤ 81 mg daily)
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00794859

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United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
King's College London
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Principal Investigator: James Spicer, MRCP, PhD King's College London

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Responsible Party: James Spicer, King's College London Identifier: NCT00794859     History of Changes
Other Study ID Numbers: 2007-005091-13
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action