Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent
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|ClinicalTrials.gov Identifier: NCT02568449|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2015
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Pleural Malignant Mesothelioma Stage IV Pleural Mesothelioma||Drug: Nintedanib||Phase 2|
I. To assess the 4-month progression-free survival (PFS) in patients with recurrent, unresectable malignant pleural mesothelioma (MAM) treated with nintedanib.
I. To assess response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in the subset of patients with measurable disease by both RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria and Modified RECIST criteria for pleural tumors.
II. To assess overall survival.
III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.
IV. To collect tissue samples for future correlative studies related to overall study objectives.
Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of BIBF 1120 (Nintedanib) in Recurrent Malignant Pleural Mesothelioma|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
Experimental: Treatment (nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Progression-free survival (PFS) [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 4 months ]PFS will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
- Incidence of grade 3-4 toxicity rate [ Time Frame: Up to 1 year ]Point and exact confidence interval estimates of the grade 3-4 toxicity rate will be computed for each type of toxicity encountered, using all toxicity evaluable patients.
- Overall survival [ Time Frame: Up to 1 year ]Overall survival will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
- Response rate (complete and partial response) [ Time Frame: Up to 1 year ]Point and exact confidence interval estimates of the (complete + partial) response rate will be computed for all patients registered (the intention-to treat population), and for the subset of response- evaluable patients.
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 ClinicalTrials.gov identifier (NCT number): NCT02568449
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Wayne State University/Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Antoinette Wozniak, M.D.||Barbara Ann Karmanos Cancer Institute|