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

NCT00951613 | Completed Phase 2 DMC

• 1 other identifier: A6012212US
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; carcinoma, lung; Sensitive-relapsed or refractory-relapsed small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the overall antitumor activity (overall response rate) of NK012

  At baseline and after every 2 cycles; PR or CR must be confirmed no less than 4 weeks after the first response was recorded

Secondary Outcomes (4)

• Progression-free survival

  Monthly for 6 months after patient goes off study, then every 3 months thereafter

• Duration of response

  Monthly for 6 months after patient goes off study, then every 3 months thereafter

• Overall survival

  Monthly for 6 months after patient goes off study, then every 3 months thereafter

• Toxicity profile of NK012

  Duration of study and up to 30 days after off-study

Interventions

NK012 DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have received one, and only one, prior chemotherapy or chemoradiotherapy regimen for either newly diagnosed extensive-stage disease or limited-stage disease.
• Prior therapies must be completed at least 4 weeks prior to enrollment and patients must have recovered from all acute toxicities.
• Measurable disease by RECIST.
• ECOG performance status of 0-2.
• At least 18 years of age.
• 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.
• 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.
• 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.
• Able to understand and show willingness to sign a written informed consent document.

You may not qualify if:

• Patient has Gilbert's Syndrome.
• Prior chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
• Lack of recovery from adverse effects due to agents administered more than 4 weeks prior to study entry.
• Concurrent use of other investigational agent.
• 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.
• Prior exposure to topoisomerase 1 inhibitors (i.e., irinotecan, topotecan, camptothecin).
• Concurrent serious infections requiring parenteral therapy.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Nippon Kayaku Co., Ltd.: lead

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David R Spigel, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2012
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

US (1)