Etirinotecan Pegol (NKTR-102) in NSCLC

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT01773109
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etirinotecan pegol (NKTR-102) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2013
Status verified
Apr 2020
Primary completion
Jan 31, 2016
Completion
Mar 15, 2017

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall Objective Response Rate [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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