Etirinotecan Pegol (NKTR-102) in NSCLC
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|ClinicalTrials.gov Identifier: NCT01773109|
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non Small Cell Lung Cancer Recurrent Non Small Cell Lung Cancer||Drug: Etirinotecan pegol (NKTR-102)||Phase 2|
This is a Phase 2 study designed to characterize the objective response rate (defined as complete response (CR) and partial response (PR)) of Etirinotecan pegol (NKTR-102) administered to subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37 eligible subjects will be enrolled at the University of Pennsylvania.
One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters and physical exam. Response will be determined by RECIST version1.1 after 2 cycles of therapy. Patients with stable disease (SD), PR or CR will continue on treatment for up to six cycles. Those who are benefitting after six cycles will have the option of continuing on treatment. Patients with progressive disease will be taken off study and will be followed for OS data.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Etirinotecan Pegol (NKTR-102) in the Treatment of Patients With Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of 2nd Line Treatment|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 15, 2017|
Experimental: Eligible patients will receive etirinotecan pegol at a dose of
single-arm, open-label study is designed to investigate the efficacy and safety of etirinotecan pegol in patients with metastatic or recurrent NSCLC after failure of 2nd line therapy. Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters (section 6.2.1) and physical exam. Response will be determined with RECIST version 1.1 after 2 cycles of therapy. Patients with Stable disease (SD), partial response (PR) or complete response (CR) will continue on additional therapy for up to six cycles. In the absence of disease progression in subjects completing six full cycles, further treatment beyond cycle #6 will be left to the discretion of the treating physician and his/her staff. Patients with progressive disease will be taken off study and will be followed for OS
Drug: Etirinotecan pegol (NKTR-102)
Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Treatment will be administered on an outpatient basis.
Other Name: Etirinotecan Pegol (Topoisomerase I Inhibitor Polymer Conjugate) is a polyethylene glycol (PEG) conjugate of irinotecan.
- Number of Adverse Events [ Time Frame: up to 18 weeks ]
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): NCT01773109
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Charu Aggarwal, MD||Abramson Cancer Center of the University of Pennsylvania|