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A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Recurrent Small Cell Lung Cancer

Thank you

Trial Information

A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer


I. To evaluate the 18-week progression free survival (PFS) rate of relapsed small cell lung
cancer (SCLC) patients treated with NKTR-102 (Etirinotecan pegol).


I. To evaluate the objective response rate. II. To evaluate the duration of response. III.
To evaluate the overall survival. IV. To evaluate the toxicity of NKTR-102 in this patient


I. To explore the correlation between UDP glucuronosyltransferase 1 family, polypeptide A
cluster (UGTIA1) polymorphisms and NKTR-102 toxicities.


Patients receive Etirinotecan pegol NKTR 102 intravenously (IV) over 90 minutes on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3
months thereafter.

Inclusion Criteria:

- Written informed consent granted prior to initiation of any study-specific screening
procedures, given with the understanding that the patient has the right to withdraw
from the study at any time, without prejudice

- Histologic or cytologic diagnosis of SCLC (Note: patients with mixed histology are
not eligible)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Presence of measurable disease defined as >= 1 lesion whose longest diameter can be
accurately measured as >= 20 mm with conventional techniques or as >= 10 mm with
spiral computed tomography (CT)

- Previously treated SCLC with only one prior treatment regimen
(cyclophosphamide/doxorubicin/vincristine [CAV] alternating with etoposide/cisplatin
[EP] is acceptable)

- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, hormonal
therapy, or surgery to National Cancer Institute (NCI)-Common Terminology Criteria
for Adverse Events (CTCAE) version 4.0 grade 1, except for diarrhea (which must be
grade 0 without supportive antidiarrheal medications) and alopecia (any grade)

- Platelet count >= 100 x 10^9/L

- Hemoglobin (Hgb) >= 9 gm/dL

- Absolute neutrophil count (ANC) >= I 500/uL

- Serum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either
measured or calculated with Cockroft and Gault formula

- Serum total bilirubin >= 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 x ULN or 5 x
ULN if caused by liver metastasis

- Women of childbearing potential must have a negative pregnancy test performed within
seven days prior to the start of study drug; male and female subjects of
child-bearing potential must agree to use double-barrier contraceptive measures, or
avoidance of intercourse during the study and for 90 days after last investigational
drug dose received

Exclusion Criteria:

- Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks
(6 weeks for nitrosoureas or mitomycin C) prior to the first day of study defined
treatment; palliative radiation < 2 weeks, biological therapy within 2 weeks,
hormonal therapy within 1 week prior to day I cycle 1

- Prior treatment with a topoisomerase-I inhibitor (e.g., topotecan, irinotecan)

- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ, unless
diagnosed and definitively treated more than 5 years prior to enrollment

- Substance abuse, medical, psychological or social conditions that may, in the opinion
of the Investigator, interfere with the patient's participation in the study or
evaluation of the study results

- Known human immunodeficiency virus (HIV) infection

- Pregnancy or breast-feeding

- Concurrent administration or received cytochrome P450 3A4 (CYP3A4) inducers or
inhibitors within 2 weeks prior to the first day of study drug treatment

- Patients with chronic or acute gastrointestinal (GI) disorders resulting in diarrhea
of any severity grade; patients who are using chronic anti-diarrheal supportive care
(more than 3 days/week) to control diarrhea in the 28 days prior to study entry

- Major surgery < 4 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy,
etc) < 2 weeks prior to the first day of study defined treatment

- Have central nervous system (CNS) metastases (unless the patient has completed
successful local therapy for CNS metastases and has been off corticosteroids for at
least 4 weeks before starting study therapy); brain imaging is required in
symptomatic patients to rule out brain metastases, but is not required in
asymptomatic patients

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Unwilling or unable to follow protocol requirements

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who are progression-free

Outcome Description:

The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier. Probability of PFS at 18 weeks and 24 weeks will be estimated.

Outcome Time Frame:

Time from registration to the date of first documented disease progression or death, assessed at 18 weeks

Safety Issue:


Principal Investigator

Alex Adjei

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:

I 225612



Start Date:

June 2013

Completion Date:

Related Keywords:

  • Recurrent Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Roswell Park Cancer Institute Buffalo, New York  14263