ClinicalTrials.gov record
Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00986674
Public ClinicalTrials.gov record NCT00986674. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination With Cetuximab, IMC-A12 or Both in Patients With Advanced Non-Small Cell Lung Cancer Who Will Not Receive Bevacizumab-Based Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized phase II trial is studying how well giving carboplatin and paclitaxel together with cetuximab and/or cixutumumab (IMC-A12) works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel are more effective when given with cetuximab and/or cixutumumab in treating non-small cell lung cancer.
Study identification
- NCT ID
- NCT00986674
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Interventions
- cixutumumab Biological
- carboplatin Drug
- paclitaxel Drug
- cetuximab Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2009 (Type not available)
- Primary completion
- Aug 2013 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Sep 26, 2014
2009 – 2013
United States locations
- U.S. sites
- 249
- U.S. states
- 23
- U.S. cities
- 174
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University Hospitals and Clinics | Stanford | California | 94305 | — |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301 | — |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | — |
| Porter Adventist Hospital | Denver | Colorado | 80210 | — |
| Exempla Saint Joseph Hospital | Denver | Colorado | 80218 | — |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| Rose Medical Center | Denver | Colorado | 80220 | — |
| Colorado Cancer Research Program CCOP | Denver | Colorado | 80224-2522 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81502 | — |
| North Colorado Medical Center | Greeley | Colorado | 80631 | — |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | — |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | — |
| Longmont United Hospital | Longmont | Colorado | 80501 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Danbury Hospital | Danbury | Connecticut | 06810 | — |
| Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | — |
| Manchester Memorial Hospital | Manchester | Connecticut | 06040 | — |
| Medical Center of Central Georgia | Macon | Georgia | 31208 | — |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61701 | — |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Graham Hospital Association | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | — |
| Memorial Hospital | Carthage | Illinois | 62321 | — |
| Eureka Hospital | Eureka | Illinois | 61530 | — |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | — |
| Evanston CCOP-NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| Illinois CancerCare Galesburg | Galesburg | Illinois | 61401 | — |
| Illinois CancerCare-Havana | Havana | Illinois | 62644 | — |
| Mason District Hospital | Havana | Illinois | 62644 | — |
| Hinsdale Hematology Oncology Associates Incorporated | Hinsdale | Illinois | 60521 | — |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | — |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | — |
| Mcdonough District Hospital | Macomb | Illinois | 61455 | — |
| Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois | 61265 | — |
| Porubcin, Michael MD (UIA Investigator) | Moline | Illinois | 61265 | — |
| Sharis, Christine M MD (UIA Investigator) | Moline | Illinois | 61265 | — |
| Spector, David MD (UIA Investigator) | Moline | Illinois | 61265 | — |
| Stoffel, Thomas J MD (UIA Investigator) | Moline | Illinois | 61265 | — |
| Trinity Medical Center | Moline | Illinois | 61265 | — |
| Holy Family Medical Center | Monmouth | Illinois | 61462 | — |
| Illinois CancerCare-Monmouth | Monmouth | Illinois | 61462 | — |
| Bromenn Regional Medical Center | Normal | Illinois | 61761 | — |
| Community Cancer Center Foundation | Normal | Illinois | 61761 | — |
| Illinois CancerCare-Community Cancer Center | Normal | Illinois | 61761 | — |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | — |
| Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois | 61350 | — |
| Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | — |
| Pekin Hospital | Pekin | Illinois | 61554 | — |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61603 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | — |
| Proctor Hospital | Peoria | Illinois | 61614 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| Illinois Oncology Research Association CCOP | Peoria | Illinois | 61615 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | — |
| Illinois Valley Hospital | Peru | Illinois | 61354 | — |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | — |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | — |
| Illinois CancerCare-Spring Valley | Spring Valley | Illinois | 61362 | — |
| Saint Margaret's Hospital | Spring Valley | Illinois | 61362 | — |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | — |
| Richard L. Roudebush Veterans Affairs Medical Center | Indianapolis | Indiana | 46202 | — |
| Wishard Hospital | Indianapolis | Indiana | 46202 | — |
| Community Howard Regional Health | Kokomo | Indiana | 46904 | — |
| Indiana University Health La Porte Hospital | La Porte | Indiana | 46350 | — |
| IU Health Arnett | Lafayette | Indiana | 47904 | — |
| Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana | 46545-1470 | — |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | — |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46628 | — |
| Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa | 52722 | — |
| Cedar Rapids Oncology Association | Cedar Rapids | Iowa | 52403 | — |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | — |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | — |
| Siouxland Hematology Oncology Associates | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center-Sioux City | Sioux City | Iowa | 51104 | — |
| Saint Luke's Regional Medical Center | Sioux City | Iowa | 51104 | — |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | — |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | — |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | — |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | — |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | — |
| Cancer Center of Kansas-Kingman | Kingman | Kansas | 67068 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67901 | — |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | — |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | — |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | — |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | — |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | — |
| Associates In Womens Health | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas - Main Office | Wichita | Kansas | 67214 | — |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | — |
| Wichita CCOP | Wichita | Kansas | 67214 | — |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Bixby Medical Center | Adrian | Michigan | 49221 | — |
| Hickman Cancer Center | Adrian | Michigan | 49221 | — |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | — |
| Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor | Michigan | 48106 | — |
| Oakwood Hospital | Dearborn | Michigan | 48124 | — |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| Green Bay Oncology - Escanaba | Escanaba | Michigan | 49431 | — |
| Hurley Medical Center | Flint | Michigan | 48502 | — |
| Genesys Regional Medical Center-West Flint Campus | Flint | Michigan | 48532 | — |
| Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan | 49801 | — |
| Allegiance Health | Jackson | Michigan | 49201 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| Sparrow Hospital | Lansing | Michigan | 48912 | — |
| Saint Mary Mercy Hospital | Livonia | Michigan | 48154 | — |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | — |
| Mercy Memorial Hospital | Monroe | Michigan | 48162 | — |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | — |
| Saint Joseph Mercy Port Huron | Port Huron | Michigan | 48060 | — |
| Saint Mary's of Michigan | Saginaw | Michigan | 48601 | — |
| Lakeland Hospital | Saint Joseph | Michigan | 49085 | — |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | — |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Essentia Health Duluth Clinic CCOP | Duluth | Minnesota | 55805 | — |
| Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | 55805 | — |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | — |
| Fairview-Southdale Hospital | Edina | Minnesota | 55435 | — |
| Unity Hospital | Fridley | Minnesota | 55432 | — |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | — |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | — |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | — |
| Metro-Minnesota CCOP | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | — |
| Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | — |
| Nebraska Cancer Research Center | Lincoln | Nebraska | 68510 | — |
| Missouri Valley Cancer Consortium CCOP | Omaha | Nebraska | 68106 | — |
| Alegent Health Immanuel Medical Center | Omaha | Nebraska | 68122 | — |
| Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | — |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | — |
| Hunterdon Medical Center | Flemington | New Jersey | 08822 | — |
| Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly | New Jersey | 08060 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Virtua West Jersey Hospital Voorhees | Voorhees Township | New Jersey | 08043 | — |
| New York Oncology Hematology PC - Albany | Albany | New York | 12206 | — |
| New York Oncology Hematology PC -Albany Medical Center | Albany | New York | 12208 | — |
| New York Oncology Hematology PC - Amsterdam | Amsterdam | New York | 12010 | — |
| New York Oncology Hematology PC-Hudson | Hudson | New York | 12534 | — |
| New York Oncology Hematology PC - Latham | Latham | New York | 12110 | — |
| New York Oncology Hematology PC - Rexford | Rexford | New York | 12148 | — |
| New York Oncology Hematology PC - Troy | Troy | New York | 12180 | — |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | — |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | — |
| Toledo Clinic Cancer Centers-Bowling Green | Bowling Green | Ohio | 43402 | — |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| North Coast Cancer Care-Clyde | Clyde | Ohio | 43410 | — |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Columbus CCOP | Columbus | Ohio | 43215 | — |
| Grant Medical Center | Columbus | Ohio | 43215 | — |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | — |
| Doctors Hospital | Columbus | Ohio | 43228 | — |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | — |
| Hematology Oncology Center Incorporated | Elyria | Ohio | 44035 | — |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | — |
| Lima Memorial Hospital | Lima | Ohio | 45804 | — |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | — |
| Saint Luke's Hospital | Maumee | Ohio | 43537 | — |
| Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio | 43537 | — |
| Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee | Ohio | 43537 | — |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | — |
| Licking Memorial Hospital | Newark | Ohio | 43055 | — |
| Fisher-Titus Medical Center | Norwalk | Ohio | 44857 | — |
| UHHS-Chagrin Highlands Medical Center | Orange | Ohio | 44122 | — |
| Saint Charles Hospital | Oregon | Ohio | 43616 | — |
| Toledo Clinic Cancer Centers-Oregon | Oregon | Ohio | 43616 | — |
| North Coast Cancer Care | Sandusky | Ohio | 44870 | — |
| Springfield Regional Medical Center | Springfield | Ohio | 45505 | — |
| Flower Hospital | Sylvania | Ohio | 43560 | — |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | — |
| The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio | 43606 | — |
| Saint Vincent Mercy Medical Center | Toledo | Ohio | 43608 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| Toledo Community Hospital Oncology Program CCOP | Toledo | Ohio | 43617 | — |
| Mercy Saint Anne Hospital | Toledo | Ohio | 43623 | — |
| Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | 43623 | — |
| Fulton County Health Center | Wauseon | Ohio | 43567 | — |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | — |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | — |
| Genesis HealthCare System | Zanesville | Ohio | 43701 | — |
| Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | 74136 | — |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2001 | — |
| Geisinger Medical Center-Cancer Center Hazelton | Hazleton | Pennsylvania | 18201 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | — |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | — |
| Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | — |
| Pottstown Memorial Medical Center | Pottstown | Pennsylvania | 19464 | — |
| Mercy Hospital | Scranton | Pennsylvania | 18501 | — |
| Scranton Hematology Oncology | Scranton | Pennsylvania | 18510 | — |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | — |
| Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania | 18711 | — |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | — |
| Mainline Health CCOP | Wynnewood | Pennsylvania | 19096 | — |
| Vanderbilt-Ingram Cancer Center Cool Springs | Franklin | Tennessee | 37067 | — |
| Nashville Oncology Associates PC | Nashville | Tennessee | 37203 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Fredericksburg Oncology Inc | Fredericksburg | Virginia | 22401 | — |
| West Virginia University Charleston | Charleston | West Virginia | 25304 | — |
| Wheeling Hospital | Wheeling | West Virginia | 26003 | — |
| Fox Valley Hematology and Oncology | Appleton | Wisconsin | 54911-3496 | — |
| Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | 54729 | — |
| Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin | 54701 | — |
| Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | 54301-3526 | — |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | — |
| Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | — |
| Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | — |
| UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin | 53038 | — |
| Gundersen Lutheran | La Crosse | Wisconsin | 54601 | — |
| UW Health Oncology - 1 South Park | Madison | Wisconsin | 53715 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Holy Family Memorial Hospital | Manitowoc | Wisconsin | 54221 | — |
| Bay Area Medical Center | Marinette | Wisconsin | 54143 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | — |
| Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin | 54154 | — |
| Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin | 54501 | — |
| Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | — |
| Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | — |
| Marshfield Clinic-Wausau Center | Wausau | Wisconsin | 54401 | — |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | — |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | — |
| Riverview Hospital | Wisconsin Rapids | Wisconsin | 54494 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00986674, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 26, 2014 · Synced Oct 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00986674 live on ClinicalTrials.gov.