AzTrials
AzTrials

Carcinoma, Non-Small Cell LungPhase 3NCT00300885

A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel and Carboplatin plus Paclitaxel in people with Carcinoma, Non-Small Cell Lung, run by Bayer at 202 sites in 21 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small Cell Lung
What is being tested?
Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel and Carboplatin plus Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
926 participants
Where
202 sitesin 21 countries
Study dates
Feb 2006to Feb 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Stage IIIB (with effusion) or Stage IV NSCLC any histology
  • No prior chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Greater than or equal to 18 years of age
  • Life expectancy at least 12 weeks
  • Adequate bone marrow, liver and renal function

Who cannot join

  • Prior systemic anti cancer therapy
  • Known brain metastasis. Patients with neurological symptoms should undergo at computed tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis
  • Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug
  • Thrombotic or embolic events including Transient ischemic attack (TIA) within the past 6 months
  • Uncontrolled hypertension
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
  • Major surgery within 4 weeks
  • Evidence or history of bleeding diathesis or coagulopathy

Trial locations and contacts

202 sites in 21 countries.

202 sites in 21 countries

United States80 sites

  • Study site

    Abingdon, Virginia, 24211

  • Study site

    Allentown, Pennsylvania, 18103

  • Study site

    Anaheim, California, 92801

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Beverly Hills, California, 90211-1850

  • Study site

    Birmingham, Alabama, 35211

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Boston, Massachusetts, 02130

  • Study site

    Burbank, California, 91595

  • Study site

    Charleston, South Carolina, 29403

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Columbus, Ohio, 43235

  • Study site

    Corona, California, 92829

  • Study site

    Dayton, Ohio, 45429

  • Study site

    Denver, Colorado, 80218

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Dover, Ohio, 44622

  • Study site

    Encinitas, California, 92024

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Fort Wayne, Indiana, 46815

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hattiesburg, Mississippi, 39401

  • Study site

    Highland, California, 92346

  • Study site

    Hutchinson, Kansas, 67502

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Indianapolis, Indiana, 46254

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kansas City, Missouri, 64131

  • Study site

    Knoxville, Tennessee, 37920

  • Study site

    Kokomo, Indiana, 46902

  • Study site

    Lakeland, Florida, 33805

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90057

  • Study site

    Louisville, Kentucky, 40215

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Merritt Island, Florida, 32952

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Morristown, New Jersey, 07962-1089

  • Study site

    Nashville, Tennessee, 37232-6307

  • Study site

    New York, New York, 10029

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32804

  • Study site

    Orlando, Florida, 32806

  • Study site

    Philadelphia, Pennsylvania, 19115

  • Study site

    Pittsfield, Massachusetts, 01201

  • Study site

    Portland, Oregon, 97213

  • Study site

    Pottsville, Pennsylvania, 17901

  • Study site

    Richlands, Virginia, 24641

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Richmond, Virginia, 23298-0037

  • Study site

    Rochester, New York, 14622

  • Study site

    Sacramento, California, 95817

  • Study site

    Salt Lake City, Utah, 84112

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Sayre, Pennsylvania, 18840

  • Study site

    Sioux City, Iowa, 51101

  • Study site

    Skokie, Illinois, 60076

  • Study site

    Skokie, Illinois, 60077

  • Study site

    Springdale, Arkansas, 72764

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Staten Island, New York, 10305

  • Study site

    Trophy Club, Texas, 76262

  • Study site

    Tucson, Arizona, 85715

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Wichita, Kansas, 67214

Other trials in United States

Brazil20 sites

  • Study site

    Barretos, São Paulo, 14784400

  • Study site

    Belo Horizonte, 30380490

  • Study site

    Brasília, Federal District, 70390907

  • Study site

    Curitiba, Paraná, 80730-180

  • Study site

    Fortaleza, Ceará, 60336-550

  • Study site

    Fortaleza, Ceará, 60430-230

  • Study site

    Goiânia, Goiás, 74605-180

  • Study site

    Jaú, São Paulo, 17210-120

  • Study site

    Joinville, Santa Catarina, 89202-050

  • Study site

    Nova Lima, Minas Gerais, 34000000

  • Study site

    Porto Alegre, Rio Grande do Sul, 90619900

  • Study site

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Study site

    Ribeirão Preto, São Paulo, 14015-140

  • Study site

    Salvador, Estado de Bahia, 40050410

  • Study site

    Santo André, São Paulo, 09090-780

  • Study site

    São Paulo, São Paulo, 01331010

  • Study site

    São Paulo, São Paulo, 04024-002

  • Study site

    São Paulo, São Paulo, 05403-000

  • Study site

    São Paulo, São Paulo

  • Study site

    Sorocaba, São Paulo, 18030-510

Other trials in Brazil

Germany16 sites

  • Study site

    Berlin, State of Berlin, 12200

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Essen, North Rhine-Westphalia, 45136

  • Study site

    Gauting, Bavaria, 82131

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Großhansdorf, Schleswig-Holstein, 22927

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 21075

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69126

  • Study site

    Hemer, North Rhine-Westphalia, 58675

  • Study site

    Hofheim, Hesse, 65719

  • Study site

    Leverkusen, North Rhine-Westphalia, 51375

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

  • Study site

    München, Bavaria, 80336

  • Study site

    Oldenburg, Lower Saxony, 26121

Other trials in Germany

Italy9 sites

  • Study site

    Bergamo, 24128

  • Study site

    Genova, 16132

  • Study site

    Milan, 20162

  • Study site

    Orbassano, Torino, 10043

  • Study site

    Parma, 43100

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06156

  • Study site

    Roma, 00152

  • Study site

    Torino, 10126

Other trials in Italy

Spain9 sites

  • Study site

    Alicante, Alicante, 03010

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Elche, Alicante, 03202

  • Study site

    Madrid, Madrid, 28006

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Pontevedra, Pontevedra, 36001

  • Study site

    Zamora, Zamora, 49021

  • Study site

    Zaragoza, Aragon, 50009

Other trials in Spain

Argentina7 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1405DCS

  • Study site

    Capital Federal-Buenos Aires, C1426ANZ

  • Study site

    El Palomar - Morón, Buenos Aires, 1684

  • Study site

    La Plata, Buenos Aires, B1900AVG

  • Study site

    Mar del Plata, Buenos Aires, B7602CBM

  • Study site

    Rosario, Santa Fe Province, 2000

  • Study site

    Santa Fe, S3000FFV

Other trials in Argentina

Australia7 sites

  • Study site

    Adelaide, South Australia, 5065

  • Study site

    Brisbane, Queensland, 4029

  • Study site

    Frankston, Victoria, 3199

  • Study site

    Melbourne, Victoria, 3144

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Port Macquarie, New South Wales, 2444

  • Study site

    Wollongong, New South Wales, 2500

Other trials in Australia

France7 sites

  • Study site

    Bobigny, 93009

  • Study site

    Caen, 14073

  • Study site

    Clamart, 92140

  • Study site

    Metz, 57000

  • Study site

    Nancy, 54100

  • Study site

    Nice, 06102

  • Study site

    Strasbourg, 67100

Other trials in France

Poland7 sites

  • Study site

    Gdansk, 80-952

  • Study site

    Krakow, 31-115

  • Study site

    Olsztyn, 10-228

  • Study site

    Otwock, 05-400

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 04-141

  • Study site

    Wroclaw, 53-439

Other trials in Poland

Canada5 sites

  • Study site

    Barrie, Ontario, L4M 6M2

  • Study site

    Brampton, Ontario, L6W 3X4

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    North Vancouver, British Columbia, V7L 2L7

  • Study site

    Regina, Saskatchewan, S4T 7T1

Other trials in Canada

Hungary5 sites

  • Study site

    Budapest, 1529

  • Study site

    Deszk, 6772

  • Study site

    Gyula, 5703

  • Study site

    Mátraháza, 3233

  • Study site

    Törökbálint, 2045

Other trials in Hungary

United Kingdom5 sites

  • Study site

    Bornemouth, Dorset, BH7 7DW

  • Study site

    Leicester, Leicestershire, LE1 5WW

  • Study site

    London, London, SE1 9RT

  • Study site

    Manchester, Manchester, M23 9LT

  • Study site

    Plymouth, Devon, PL6 8DH

Other trials in United Kingdom

Belgium4 sites

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Charleroi, 6000

  • Study site

    La Louvière, 7100

  • Study site

    Liège, 4000

Other trials in Belgium

Chile4 sites

  • Study site

    Santiago, Santiago Metropolitan, 838-0455

  • Study site

    Santiago, 760 0448

  • Study site

    Santiago, 836-0156

  • Study site

    Santiago

Other trials in Chile

Russia4 sites

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 117837

  • Study site

    Moscow, 143423

  • Study site

    Saint Petersburg, 198255

Other trials in Russia

South Korea3 sites

  • Study site

    Seoul, 110-799

  • Study site

    Seoul, 135710

  • Study site

    Seoul, 138736

Other trials in South Korea

Sweden3 sites

  • Study site

    Gävle, 801 87

  • Study site

    Stockholm, 171 76

  • Study site

    Uppsala, 751 85

Other trials in Sweden

Taiwan3 sites

  • Study site

    Taichung, 40705

  • Study site

    Taipei, 110

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Netherlands2 sites

  • Study site

    Eindhoven, North Brabant, 5623 EJ

  • Study site

    Zwolle, 8011 JW

Other trials in Netherlands

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

Puerto Rico1 site

  • Study site

    San Juan, 00921

Other trials in Puerto Rico

About this study

A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.

Being tested
Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel, Carboplatin plus Paclitaxel
Keywords
Non-Small Cell Lung Cancer, NSCLC
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.

  • Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxelDrug

    Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.

  • Carboplatin plus PaclitaxelDrug

    Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Study groups in NCT00300885
Study groupRoleWhat they receive
Sorafenib + C/PExperimentalChemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
Receives: Drug: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel
Placebo + C/PActive comparatorChemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
Receives: Drug: Carboplatin plus Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo

    Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.

    Measured: Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.

    Measured: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

  2. Overall Best Response

    Best overall tumor response for the ITT population was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased).

    Measured: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

  3. Duration of Response

    Duration of response (PR or better) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented).

    Measured: Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis

  4. Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)

    Functional Assessment of Cancer Therapy - Lung cancer subscore (FACT-L). Patient reported outcome as assessed by FACT-L score. FACT-L questionnaire comprises statements about physical, social / family, emotional and functional well-being as well as additional concerns which have to be rated by the patients (0="not at all" to 4="very much"). Cycle duration defined as 21 days. Change from baseline in Total FACT-L on day 1 of cycles 3,5,7,9 (weeks 7,13,19 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.

    Measured: Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis

  5. Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)

    Lung Cancer Symptoms (LCS) subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). Cycle duration defined as 21 days. Change from baseline in LCS Subscale on day 1 of cycles 2 through 9 (weeks 4,7,10,13,16,19,22 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.

    Measured: Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionOct 2007
  4. Study completionFeb 2009

Why it stopped: Based on the results of the interim analysis, it was determined that the study would not meet its primary efficacy endpoint and the study was terminated early.

Resources

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
Double blind
Enrolment
926 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00300885
Sponsor's protocol ID
11961
Other IDs
2005-005245-19, 2005
Status last verified
Oct 2014
First submitted
8 Mar 2006
Last updated
4 Nov 2014
Data monitoring committee
No

Publications

  • Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

    PubMed 20212250

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel and Carboplatin plus Paclitaxel in people with Carcinoma, Non-Small Cell Lung, run by Bayer at 202 sites in 21 countries.

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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 202 sites in United States, Brazil, Germany, Italy, Spain and 16 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?

Yes. Results are posted in the registry (first posted 20 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo (time frame: Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00300885, which also lists 1 linked publication.

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 4 Nov 2014.

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