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Trial record 16 of 352 for:    "Malignant mesothelioma"

S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00770120
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Malignant Mesothelioma
Intervention: Drug: everolimus

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Everolimus

Daily oral Everolimus 10 mg/day

everolimus


Participant Flow:   Overall Study
    Everolimus
STARTED   61 
Eligible   60 
Not Analyzable   1 
COMPLETED   0 
NOT COMPLETED   61 
Progression                31 
Adverse Event                11 
Not Protocol Specified                11 
Death                3 
Withdrawal by Subject                2 
Ineligible                1 
Never Received Treatment/Not Analyzable                1 
Reason under Review                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of patients who were eligible and received treatment and thus analyzable.

Reporting Groups
  Description
Everolimus

Daily oral Everolimus 10 mg/day

everolimus


Baseline Measures
   Everolimus 
Overall Participants Analyzed 
[Units: Participants]
 59 
Age 
[Units: Years]
Median (Full Range)
 67 
 (45.8 to 81.3) 
Gender 
[Units: Participants]
Count of Participants
 
Female      14  23.7% 
Male      45  76.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      9  15.3% 
Not Hispanic or Latino      47  79.7% 
Unknown or Not Reported      3   5.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   1.7% 
White      55  93.2% 
More than one race      0   0.0% 
Unknown or Not Reported      3   5.1% 
Histology 
[Units: Participants]
 
Epithelial   36 
Mesothelioma, NOS   17 
Biphasic   4 
Not Reported   2 
Number of Metastatic Sites 
[Units: Participants]
 
None   5 
Single   23 
Multiple   31 
Prior Systemic Regimens 
[Units: Participants]
 
1 Regimen   34 
2 Regimens   25 
Performance Status [1] 
[Units: Participants]
 
 13 
 46 
[1]

0: Fully active, able to carry on all pre-disease performance without restriction.

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
  2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
  3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours.
  4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
Weight Loss Last 6 Months 
[Units: Participants]
 
< 5%   47 
5% - < 10%   6 
10% - 20%   6 


  Outcome Measures

1.  Primary:   Progression-Free Survival   [ Time Frame: Every 8 weeks until disease progression, up to 3 years. ]

2.  Secondary:   Response   [ Time Frame: Every 8 weeks until disease progression, up to 3 years. ]

3.  Secondary:   Overall Survival   [ Time Frame: Every 8 weeks until disease progression, up to 3 years. ]

4.  Secondary:   Frequency and Severity of Toxicities   [ Time Frame: Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lung Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-6197
e-mail: jmoon@fredhutch.org


Publications of Results:
Garland LL, Ou SH, Moon J, et al.: SWOG 0722: A phase II study of mTOR inhibitor everolimus (RAD001) in malignant pleural mesothelioma (MPM). [Abstract] J Clin Oncol 30 (Suppl 15): A-7083, 2012.


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00770120     History of Changes
Other Study ID Numbers: CDR0000616162
S0722 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: October 8, 2008
First Posted: October 9, 2008
Results First Submitted: October 26, 2016
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017