Etirinotecan Pegol (NKTR-102) in NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01773109
First received: January 18, 2013
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Non Small Cell Lung Cancer
Recurrent Non Small Cell Lung Cancer
Drug: Etirinotecan pegol (NKTR-102)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: up to 18 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic or recurrent NSCLC. Primary or metastatic site may be used for histology.
  • After failure of 2nd line treatment with up to two prior lines of therapy, one of which may be an oral TKI.
  • Measurable disease (Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented incontrovertibly either radiographically or pathologically. For clinicians relying on biopsy documentation of recurrence, this must be obtained to confirm persistence at least 90 days following completion of radiation therapy).
  • Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
  • Age at the time of study entry is ≥ 18 years.
  • Adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9.0 g/dL, and a platelet count ≥ 100,000/μL obtained within 2 weeks prior to enrollment.
  • Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 × the upper limit of normal ([ULN]), or ≤ 5 × the ULN in the presence of known liver metastases.
  • Alkaline phosphatase (AP) ≤ 3 x the ULN or ≤ 5 × the ULN in the presence of known liver metastases
  • Adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the patient's measured or calculated creatinine clearance (CrCl) must be ≥ 50 mL/min.
  • Resolution of chemotherapy and radiation therapy related toxicities to NCI-CTCAE version 4.0 Grade 1 or lower severity, except for diarrhea (which must be Grade 0 without a supportive antidiarrheal medications) and alopecia (any grade).
  • Women of childbearing potential and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to enrollment and for the duration of study participation. Protections against pregnancy must be continued for at least 8 months after the last dose of study drug.
  • Signed informed consent.

Exclusion Criteria:

  • Untreated central nervous system metastases. Patients are eligible if they are clinically stable, off all steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radio surgery) ending at least 2 weeks prior to enrollment, or after surgical resection performed at least 2 weeks prior to enrollment.
  • History of another "active" invasive primary cancer requiring ongoing treatment.
  • Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent.
  • Patients who have had chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C), radiotherapy within 14 days, biological therapy within 14 days, hormonal therapy within 7 days, and investigational therapy within 21 days prior to enrollment.
  • Patients who have had any major surgery within 21 days prior to enrollment.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with chronic or acute 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 enrolment.
  • Administration of the CYP3A4 inducers or inhibitors, as they may induce or inhibit irinotecan or SN38 metabolism within 14 days prior to cycle 1 and throught study treatment. For a list of these agents, see: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm
  • Uncontrolled thrombotic or hemorrhagic disorder.
  • Known human immunodeficiency virus (HIV) positivity.
  • The patient, if female, is pregnant or lactating.
  • Previous therapy with a topoisomerase I or II inhibitor.
  • Known allergy to any of the treatment components.
  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: NCT01773109

Contacts
Contact: Charu Aggarwal, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Charu Aggarwal, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Charu Aggarwal, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Charu Aggarwal, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01773109     History of Changes
Other Study ID Numbers: UPCC 18512
Study First Received: January 18, 2013
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Male and female subjects 18 years of age and older
metastatic or recurrent NSCLC
who have failed 2nd line therapy (with up to two prior cytotoxic regimens and one prior exposure to an oral TKI).

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014