Study of ILX651 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
1 other identifier
interventional
N/A
1 country
10
Brief Summary
This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2003
10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 25, 2004
CompletedFirst Posted
Study publicly available on registry
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedMarch 5, 2015
March 1, 2015
February 25, 2004
March 4, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed locally advanced or metastatic NSCLC previously treated with 2 prior chemotherapy regimens (not including prior adjuvant therapy for stage I or II disease).
- Disease recurrence or progression after prior therapy with a platinum-based and a taxane-based regimen, given either concurrently or separately.
- Measurable disease. Measurable lesions should be outside the field of radiation. Where measurable lesions are within a previously irradiated field, there must be objective evidence of progression of the lesion prior to patient enrollment.
- Male or female patients greater than or equal to 18 years of age.
- ECOG performance status of 0 or 1.
- Must have adequate organ and immune system function as indicated by the following laboratory values, obtained less than or equal to 2 weeks prior to registration: A. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 1,000,000,000. B. Hemoglobin greater than or equal to 9.0 g/dL. C. Platelet count greater than or equal to 100 x 1,000,000,000/L. D. Serum creatinine or calculated creatinine clearance less than or equal to 1.5 mg/dL or greater than or equal to 60 mL/min. E. Serum total bilirubin within limits of normal values. F. AST and ALT less than or equal to 2 times the upper limit of normal (ULN). G. Alkaline phosphatase within limits of normal values
- Anti-cancer therapy, major surgery, or irradiation must have been completed at least 3 weeks before enrollment in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
- Female patients with childbearing potential must have a negative pregnancy test within 7 days of study enrollment. Men and women of reproductive potential must use an effective contraceptive method while enrolled in the study.
- Signed informed consent (includes HIPAA authorization).
You may not qualify if:
- Patients with uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment, or patients with cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification.
- Previously treated with \> 2 prior chemotherapy regimens for advanced or metastatic disease.
- Prior radiotherapy to the only site of measurable disease.
- Known hypersensitivity to study drug or its analogs.
- Use of investigational agents within previous 30 days.
- Known, active infection, or known HIV positive or presence of an AIDS related illness.
- Active secondary malignancy except minor skin cancers.
- Presence of symptomatic active brain metastases, including leptomeningeal involvement.
- Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results.
- Pregnant or lactating females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
US Oncology/ Arizona Clinical Research Center
Tucson, Arizona, 85712, United States
Cancer Institute Medical Group
Santa Monica, California, 90404, United States
Anshutz Cancer Pavillion
Aurora, Colorado, 80010, United States
US Oncology / Ocala Oncology
Ocala, Florida, 34474, United States
US Oncology / Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Hematology and Oncology Specialists
New Orleans, Louisiana, 70115, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
US Oncology / Texas Cancer Center
Dallas, Texas, 75230, United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410, United States
US Oncology / Tyler Cancer Center
Tyler, Texas, 75702, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 25, 2004
First Posted
March 1, 2004
Study Start
December 1, 2003
Study Completion
August 1, 2005
Last Updated
March 5, 2015
Record last verified: 2015-03