Oral NRX 194204 Study in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Multiple-Center, Open-Label, Study of the Safety and Efficacy of Oral NRX 194204 Capsule Administered Daily for a Minimum of 4 Weeks in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
48
1 country
6
Brief Summary
The purpose of this study is to determine whether NRX 194204 is effective in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Mar 2009
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedSeptember 3, 2009
September 1, 2009
1 year
August 20, 2009
September 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall objective tumor response rate
7 months
Secondary Outcomes (3)
Progression free survival
7 months
Overall survival
7 months
Overall safety and toxicity of NRX 194204 in NSCLC patients
7 months
Study Arms (1)
NRX194204
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female, age ≥ 18 years
- Histologically confirmed advanced stage III or IV NSCLC that is recurrent or has progressed after treatment. Failure on at least 2 NSCLC treatment regimens
- Uni-dimensionally measurable NSCLC defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 2cm with conventional techniques or as ≥ 1cm on spiral CT scan.
- Patients are eligible if disease free from previous malignancies, other than a previous NSCLC, for greater than two years. Patients with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are not excluded.
- Karnofsky performance status ≥ 60 (Attachment 14.4) or ECOG performance status 0-2
- Life expectancy \> 12 weeks.
- Able to swallow capsule form of the drug.
- Hematology:
- Hemoglobin \> 8.5 g/dl;
- Platelets \> 100,000 cells/mm3;
- Neutrophils \> 1500 cells/mm3;
- PT and PTT within normal limits, except for patients receiving Coumadin for thromboembolic prophylaxis only, in whom INR of less than 2 will be allowable.
- Biochemistry:
- Total bilirubin \< 1.5 x ULN;
- AST/ALT \< 3.0 x ULN;
- +5 more criteria
You may not qualify if:
- Significant medical history or unstable medical condition (congestive heart failure, recent myocardial infarction within 3 months, unstable angina, active systemic infection, uncontrolled hypertension). Patients with controlled diabetes will be allowed.
- Prior treatment with bexarotene (Targretin) or NRX 194204.
- Current enrollment in an investigational drug or device study or participation in such a study within 21 days of entry into this study.
- Known sensitivity to any of the ingredients in the study medication.
- Known HIV-positive patients.
- Females who are pregnant, nursing, or planning a pregnancy.
- Major surgery within previous 4 weeks; large field radiation therapy (\> 25% of the patient's total marrow) or chemotherapy (including investigational agents or participation in another clinical study) within previous 3 weeks; mitomycin C or nitrosoureas within 6 weeks. In all instances, patients must have fully recovered from acute toxicities related to prior therapies.
- Systemic retinoid therapy, or Vitamin A at dosages \> 15,000 IU per day, during previous 4 weeks.
- Patients with a history of pancreatitis or at significant risk of developing pancreatitis (e.g., uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity).
- Primary brain tumors, active brain metastasis including progression from last scan or evidence of cerebral edema, or clinical symptoms of brain metastasis.
- Condition or situation which, in the investigator's opinion, may put patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Dr. Pandit
Fountain Valley, California, 92708, United States
UCSD Moores Cancer Center
La Jolla, California, 92093-0698, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Somerset Oncology Hematology Associates
Somerville, New Jersey, 08876, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 24, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
June 1, 2010
Last Updated
September 3, 2009
Record last verified: 2009-09