Etirinotecan Pegol (NKTR-102) in NSCLC
NCT01773109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-04-03
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.
Conditions
- Metastatic Non Small Cell Lung Cancer
- Recurrent Non Small Cell Lung Cancer
Interventions
- 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.
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Charu Aggarwal, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2016-01-31
- Completion
- 2017-03-15
Countries
- United States
Study Locations
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