Trial record 1 of 1 for:    NCT01876446
Previous Study | Return to List | Next Study

Etirinotecan Pegol (NKTR 102) in Treating Patients With Relapsed Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
Nektar Therapeutics
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01876446
First received: June 10, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This phase II trial studies how well etirinotecan pegol (NKTR 102) works in treating patients with relapsed small cell lung cancer. Etirinotecan pegol (NKTR 102) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Condition Intervention Phase
Recurrent Small Cell Lung Cancer
Drug: etirinotecan pegol (NKTR 102)
Other: pharmacogenomic studies
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Proportion of patients who are progression-free [ Time Frame: Time from registration to the date of first documented disease progression or death, assessed at 18 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    The distribution of survival time will be estimated in each group using the method of Kaplan-Meier. Probability of survival at 3, 6, and 9 months will be estimated.

  • Objective tumor response measured with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    Objective tumor response will be tabulated overall (and by dose level if appropriate).

  • Best response, defined as best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started), measured by RECIST 1.1 [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in the cohorts (overall and by tumor group).

  • Incidence of hematologic and non-hematologic toxicity per NCI Common Toxicity Criteria (CTC) [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

  • Number and severity of adverse events, assessed using NCI CTCAE v 4.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    The number and severity of all adverse events (overall, by regimen, and by dose level if appropriate) will be tabulated and summarized. The grade 3+ adverse events will also be described and summarized in a similar fashion.


Estimated Enrollment: 38
Study Start Date: August 2013
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment etirinotecan pegol (NKTR 102)
Patients receive etirinotecan pegol (NKTR 102) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Drug: etirinotecan pegol (NKTR 102)
Given IV
Other Names:
  • NKTR 102
  • etirinotecan pegol
Other: pharmacogenomic studies
Correlative studies
Other Name: Pharmacogenomic Study
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

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

(SECONDARY OBJECTIVES: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 etirinotecan pegol(NKTR-102) in this patient population.

TERTIARY OBJECTIVES:

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

OUTLINE:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) >= 1500/uL
  • Serum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either measured or calculated with Cockcroft-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 6 months 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 to concerns of potential drug interaction with various antiretroviral agents.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876446

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Alex A. Adjei         
Sponsors and Collaborators
Roswell Park Cancer Institute
Nektar Therapeutics
Investigators
Principal Investigator: Alex Adjei Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01876446     History of Changes
Other Study ID Numbers: I 225612, NCI-2013-01142, P30CA016056
Study First Received: June 10, 2013
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014