A Study of NK012 in Patients With Relapsed Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00951613
First received: May 21, 2009
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of relapsed small cell lung cancer.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: NK012
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of NK012 in Sensitive Relapsed and Refractory Relapsed Small-Cell Lung Cancer (SCLC)

Resource links provided by NLM:


Further study details as provided by Nippon Kayaku Co.,Ltd.:

Primary Outcome Measures:
  • To evaluate the overall antitumor activity (overall response rate) of NK012 [ Time Frame: At baseline and after every 2 cycles; PR or CR must be confirmed no less than 4 weeks after the first response was recorded ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter ] [ Designated as safety issue: No ]
  • Toxicity profile of NK012 [ Time Frame: Duration of study and up to 30 days after off-study ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: July 2009
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: NK012
    30 minute IV infusion once every 28 days. NK012 dose is 28 mg/m^2 (or 18 mg/m^2 depending on UGT1A1 polymorphism, with potential to dose escalate). Dose escalation cannot exceed 28 mg/m^2. Dosing will proceed until progression or unacceptable toxicity develops, or decision by patient or investigator to stop.
Detailed Description:

This is a Phase II, open label, single arm, multicenter study of NK012 in patients with sensitive relapsed SCLC (at least 90 days since first line therapy) or refractory relapsed SCLC (< 90 days since first line therapy). NK012 will be administered by intravenous infusion over 30 minutes once every 28 days (on Day 1 of each cycle). Patients will be screened for UGT1A1 polymorphism prior to enrollment.

  Eligibility

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

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of SCLC, which has relapsed after first line chemotherapy for extensive-stage SCLC or first-line chemoradiotherapy for limited-stage SCLC.
  2. Have received one, and only one, prior chemotherapy or chemoradiotherapy regimen for either newly diagnosed extensive-stage disease or limited-stage disease.
  3. Prior therapies must be completed at least 4 weeks prior to enrollment and patients must have recovered from all acute toxicities.
  4. Measurable disease by RECIST.
  5. ECOG performance status of 0-2.
  6. At least 18 years of age.
  7. Adequate bone marrow function as defined by absolute neutrophil count of greater than or equal to 1,500/mm^3 and platelets of greater than or equal to 100,000/mm^3.
  8. AST (SGOT) and ALT (SGPT) levels no greater than 3 x the institutional ULN, and total bilirubin less than or equal to 1.5 x ULN.
  9. Serum creatinine less than or equal to 1.5 x ULN, or creatinine clearance greater than or equal to 60 mL/min (Cockcroft-Gault formula) for patients with serum creatinine levels > 1.5 x ULN.
  10. Able to understand and show willingness to sign a written informed consent document.

Exclusion criteria:

  1. Patient has Gilbert's Syndrome.
  2. Prior chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
  3. Lack of recovery from adverse effects due to agents administered more than 4 weeks prior to study entry.
  4. Concurrent use of other investigational agent.
  5. History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for > 1 week.
  6. Prior exposure to topoisomerase 1 inhibitors (i.e., irinotecan, topotecan, camptothecin).
  7. Concurrent serious infections requiring parenteral therapy.
  8. Pregnant or of childbearing potential and not using methods to avoid pregnancy. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed infants while on this study.
  9. Significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias or poorly controlled angina.
  10. History of serious ventricular arrhythmia (VT or VF, greater than or equal to 3 beats in a row), QTc greater than or equal to 450 msec for men and 470 msec for women, or LVEF less than or equal to 40% by MUGA or ECHO.
  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: NCT00951613

Locations
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Nippon Kayaku Co.,Ltd.
Investigators
Principal Investigator: David R Spigel, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: Nippon Kayaku Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00951613     History of Changes
Other Study ID Numbers: A6012212US
Study First Received: May 21, 2009
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Nippon Kayaku Co.,Ltd.:
small cell lung cancer
carcinoma, lung
Sensitive-relapsed or refractory-relapsed small cell lung cancer

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

ClinicalTrials.gov processed this record on September 29, 2014