NCT01773109

Etirinotecan Pegol (NKTR-102) in NSCLC

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Non Small Cell Lung Cancer
• Recurrent Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-01-01
• Completion: 2017-03-15
• First posted: 2013-01-23
• Last updated: 2020-04-03
• Results posted: 2020-04-03

Locations

1 site across 1 country: United States