Etirinotecan Pegol (NKTR-102) in NSCLC
This Phase 2 study is designed to characterize the objective response rate (defined as complete response (CR) and partial response (PR)) of Etirinotecan pegol administered to subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37 eligible subjects will receive the investigational drug q3 weeks until they are no longer benefiting.
Metastatic Non Small Cell Lung Cancer
Recurrent Non Small Cell Lung Cancer
Drug: Etirinotecan pegol (NKTR-102)
|Study Design:||Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|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|
- Number of Adverse Events [ Time Frame: up to 18 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|