Non-small Cell Lung CancerPhase 3NCT00050973
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 3 study testing bexarotene in people with Non-small Cell Lung Cancer, run by Eisai Inc. at 77 sites in 11 countries.
Trial summary
This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- bexarotene
- How many people
- 623 participants
- Where
- 77 sitesin 11 countries
- Study dates
- Start not givento Mar 2005
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients must have:
- Pathologic (histologic or cytologic) confirmation of NSCLC
- Stage IIIB with malignant pleural effusion or Stage IV disease
- At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
- ECOG performance status 0 or 1
- Adequate organ system function
- Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).
Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)
Patients must not have had:
- Brain metastasis
- Prior chemotherapy for NSCLC
- Prior platinum-based chemotherapy for any indication
Trial locations and contacts
77 sites in 11 countries.
77 sites in 11 countries
United States20 sites
Northwest Medical Specialists
Arlington Heights, Illinois, 60004
Brookwood Medical Center
Birmingham, Alabama, 35209
SUNY Downstate Medical Center
Brooklyn, New York, 11203
VA Western New York Health Care System
Buffalo, New York, 14215
University Oncology & Hematology Associates
Chattanooga, Tennessee, 37404
University of Florida
Gainsville, Florida, 32610
New Hope Cancer Center
Hudson, Florida, 34667
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
Marshfield Medical Research Foundation
Marshfield, Wisconsin, 54449
Medical Associates Health Centers
Menomonee Falls, Wisconsin, 53051
Jayne Gurtler, M.D., APMC
Metairie, Louisiana, 70006
Veterans Affairs Medical Center
Miami, Florida, 33125
Tariq Mahmood
Midwest City, Oklahoma, 73110
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Bay Area Cancer Consultants
Palm Harbor, Florida, 34684
Arroyo Research Inc.
Pasadena, California, 91105
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Desert Hematology-Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
Hematology-Oncology Associates
Toledo, Ohio, 43623
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723
Russia9 sites
Arkhangelsk Regional Oncology Center
Arkhangelsk, 163045
City Oncology Clinical Center
Moscow, 107005
Russian Oncology Research Center n.a. Blokhin
Moscow, 115478
Research Institute of Oncology n.a. Hertzen
Moscow, 12584
Central Clinical Hospital n.a. Semashko
Moscow, 129128
City Oncology Hospital #62
Moscow, 143423
City Oncology Center
Saint Petersburg, 197022
St. Petersburg Pavlov State Medical University
Saint Petersburg, 197089
Research Institute of Oncology n.a. Petrov
Saint Petersburg, 197758
Australia8 sites
Box Hill Hospital
Box Hill, Victoria, 3128
Canberra Hospital
Garran, Australian Capital Territory, 2605
Royal Hobart Hospital
Hobart, Tasmania, 7001
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
Burnside War Memorial Hospital
Toorak Gardens, South Australia, 5065
Border Medical Oncology
Wodonga, Victoria, 3690
Southern Medical Daycare Centre
Wollongong, New South Wales, 2500
Queen Elizabeth Hospital
Woodville, South Australia, 5011
Greece7 sites
6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest
Athens, 11527
7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest
Athens, 11527
University Hospital of Alexandroupolis
Dragana, Alexandroupolis, 68100
1st Pulmonary Clinic of G. Papanikolaou Hospital
Exochi, Thessaloniki, 57010
2nd Pulmonary Clinic of G. Papanikolaou Hospital
Exochi, Thessaloniki, 57010
University General Hospital of Heraklion
Heraklion, Crete
University Hospital of Patras
Rio, 26500
Israel7 sites
Barzilai Medical Centre
Ashkelon, 78308
Hadassah Medical Center
Jerusalem, 19200
Meir Hospital
Kfar Saba, 44281
Kaplan Medical Center
Rehovot, 76100
Tel-Aviv Sovrasky Medical Center
Tel Aviv, 64239
Sheba Medical Center
Tel HaShomer, 52620
Assaf Harofeh Medical Center
Tsrifin, 70300
United Kingdom6 sites
Bristol Hematology and Oncology Centre
Bristol, England, BS2 8ED
University of Edinburgh
Edinburgh, Scotland, EH4 2XU
Aberdeen Royal Infirmary
Foresterhill, Aberdeen, AB25 2ZN
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Guys & St. Thomas' Cancer Centre
London, England, SE1 9RT
Chelsea & Westminster Hospital
London, England, SW10 9NH
Poland5 sites
Regionalne Centrum Onkologii
Bialystok, 15-027
Akademii Medycznej w Gdansku
Gdansk, 80-216
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Krakow, 31-115
Wielkopolskie Centrum Chorob Pluc I Gruzlicy
Poznan, 66-569
Instytut Gruzlicy i Chorob Pluc
Warsaw, 01-138
Canada4 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Cancer Care Manitoba
Winnepeg, Manitoba, R3E 0V9
France4 sites
Centre Hospitalier General de Belfort
Belfort, Cedex, 90016
Centre Hospitalier Francois Maillot
Briey, Cedex, 54150
Institut Jean Godinot
Reims, Cedex, 51100
Centre Hospitalier Intercommunal de la Haute-Saone
Vesoul, Cedex, 70014
Hungary4 sites
Semmelweis University Department of Pulmonology
Budapest, 1125
Fovarosi Onkormanyzat Uzsoki utcai, Korhaza
Budapest, 1145
Koranyi National Institute for Pulmonology
Budapest, 1529
Csongrad Megyei Onkormanyzat Mellkasi
Deszk, 6772
Czechia3 sites
Nemocnice odd. Onkologie
České Budějovice, 370 87
Pneumologicka klinika 1. LF UK
Praha-6-Veleslavin, CZ-160 00
Klinika pneumologie a hrudni chirurgie 3.LF
Praha-8, CZ-180 00
About this study
Official title: Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.
Read the detailed description
This study evaluates the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- bexarotene
- Keywords
- NSCLC, Targretin, Retinoid, Bexarotene
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bexaroteneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2003 (estimated)
- Primary completionNov 2004
- Study completionMar 2005
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.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mack Mabry, M.D., Study director, Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050973
- Sponsor's protocol ID
- L1069-49
- Status last verified
- Jul 2008
- First submitted
- 31 Dec 2002
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00050973
- Acronym / sponsor ID
- L1069-49
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, Targretin, Retinoid, Bexarotene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Primary completion
- Nov 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 3 Jan 2003 (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.
This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.
Detailed description
This study evaluates the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| bexarotene | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- Related InfoLink provided by the sponsor.
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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.
Mack Mabry, M.D. study director
Ligand Pharmaceuticals
77 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bexarotene in people with Non-small Cell Lung Cancer, run by Eisai Inc. at 77 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Russia, Australia, Greece, Israel and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 14 May 2013.