Non-small Cell Lung CancerPhase 2NCT00964132
Oral NRX 194204 Study in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing NRX194204 in people with Non-small Cell Lung Cancer, run by NuRx Pharmaceuticals, Inc. at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- NRX194204
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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;
- Serum creatinine < 2.0 mg/dl;
- Serum calcium < 11.5 mg/dl;
- Fasting serum triglycerides < 2.5 x ULN.
- Negative urine pregnancy test for women of child-bearing potential at screening and on Day 1, and agreement by both women and men of reproductive potential to use two reliable forms of contraception during therapy and for 1 month following discontinuation of therapy unless abstinence is the chosen birth control method.
- Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dr. Pandit
Fountain Valley, California, 92708
UCSD Moores Cancer Center
La Jolla, California, 92093-0698
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Swedish Cancer Institute
Seattle, Washington, 98104
Somerset Oncology Hematology Associates
Somerville, New Jersey, 08876
About this study
Official title: 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)
The purpose of this study is to determine whether NRX 194204 is effective in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs. Because NRX 194204 is significantly more selective for the RXRs relative to the RARs than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients who have failed any 2 prior therapies.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- NRX194204
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Rexinoid, NRX194204, Lung Cancer, RXR
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRX194204Drug
Once Daily, Oral
| Study group | Role | What they receive |
|---|---|---|
| NRX194204 | Experimental | Not described Receives: Drug: NRX194204 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall objective tumor response rate
Measured: 7 months
Secondary outcomes (3)
Progression free survival
Measured: 7 months
Overall survival
Measured: 7 months
Overall safety and toxicity of NRX 194204 in NSCLC patients
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuRx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964132
- Sponsor's protocol ID
- 194204-203
- Status last verified
- Sep 2009
- First submitted
- 20 Aug 2009
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00964132
- Acronym / sponsor ID
- 194204-203
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Rexinoid, NRX194204, Lung Cancer, RXR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- NuRx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether NRX 194204 is effective in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC).
Detailed description
Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs. Because NRX 194204 is significantly more selective for the RXRs relative to the RARs than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients who have failed any 2 prior therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRX194204 | Experimental | Drug: NRX194204 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRX194204Once Daily, Oral | Drug | NRX194204 |
Primary outcome
Overall objective tumor response rate
Time frame: 7 months
3 secondary outcomes
Progression free survival
Time frame: 7 months
Overall survival
Time frame: 7 months
Overall safety and toxicity of NRX 194204 in NSCLC patients
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRX194204 in people with Non-small Cell Lung Cancer, run by NuRx Pharmaceuticals, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall objective tumor response rate (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2009.