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Trial record 11 of 21 for:    "Adenoma" | "Sirolimus"

Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity

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ClinicalTrials.gov Identifier: NCT01024946
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : April 20, 2015
Last Update Posted : May 12, 2015
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Dana-Farber Cancer Institute
University of Pennsylvania
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Pleural Mesothelioma
Intervention Drug: everolimus
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Getting Everolimus
Hide Arm/Group Description

This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.

everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity

Period Title: Overall Study
Started 11
Completed 6
Not Completed 5
Reason Not Completed
Screen Failure             3
Withdrawal by Subject             1
Adverse Event             1
Arm/Group Title Patients Getting Everolimus
Hide Arm/Group Description

This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.

everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  63.6%
>=65 years
4
  36.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
1
   9.1%
Male
10
  90.9%
1.Primary Outcome
Title To Determine the Rate of Clinical Benefit (i.e. Rate of Complete or Partial Response Plus Stable Disease) at 16 Weeks for Patients With Malignant Mesothelioma Treated With Everolimus as Second or Third Line Therapy.
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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 Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Getting Everolimus
Hide Arm/Group Description:

This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.

everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Stable Disease 4
Progression of Disease 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Getting Everolimus
Hide Arm/Group Description

This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.

everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity

All-Cause Mortality
Patients Getting Everolimus
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Getting Everolimus
Affected / at Risk (%) # Events
Total   3/7 (42.86%)    
Blood and lymphatic system disorders   
Hemorrhage/Bleeding, other  1  1/7 (14.29%)  1
Gastrointestinal disorders   
Constipation  1  1/7 (14.29%)  2
Musculoskeletal and connective tissue disorders   
Inf norm ANC/gr1/2 neut-Myositis infection(muscle)  1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  2/7 (28.57%)  2
Pneumonitis/pulmonary infiltrates  1  1/7 (14.29%)  1
Ascites (non-malignant)  1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Inf norm ANC/gr1/2 neut-Cellulitis(skin)  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients Getting Everolimus
Affected / at Risk (%) # Events
Total   6/7 (85.71%)    
Blood and lymphatic system disorders   
Glucose, high (hyperglycemia)  1  4/7 (57.14%)  4
Hemoglobin  1  2/7 (28.57%)  2
Leukocytes (total WBC)  1  2/7 (28.57%)  2
Lymphopenia  1  1/7 (14.29%)  1
Neutrophils/granulocytes (ANC/AGC)  1  2/7 (28.57%)  2
Platelets  1  1/7 (14.29%)  1
Gastrointestinal disorders   
Constipation  1  1/7 (14.29%)  1
General disorders   
Anorexia  1  1/7 (14.29%)  1
Fatigue (asthenia, lethargy, malaise)  1  4/7 (57.14%)  6
Insomnia  1  1/7 (14.29%)  1
Rigors/chills  1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Albumin, low (hypoalbuminemia)  1  4/7 (57.14%)  4
ALT, SGPT  1  1/7 (14.29%)  1
Sodium, low (hyponatremia)  1  1/7 (14.29%)  1
Psychiatric disorders   
Mood alteration - Anxiety  1  1/7 (14.29%)  1
Renal and urinary disorders   
Bilirubin (hyperbilirubinemia)  1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/7 (57.14%)  4
Dyspnea (shortness of breath)  1  4/7 (57.14%)  7
Pneumonitis/pulmonary infiltrates  1  2/7 (28.57%)  2
Skin and subcutaneous tissue disorders   
Dry skin  1  1/7 (14.29%)  1
Rash/desquamation  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lee Krug
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4201
EMail: krugl@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01024946     History of Changes
Other Study ID Numbers: 09-142
First Submitted: December 2, 2009
First Posted: December 3, 2009
Results First Submitted: April 7, 2015
Results First Posted: April 20, 2015
Last Update Posted: May 12, 2015