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Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

NCT ID: NCT00043927

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

Detailed Description

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Conditions

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Small Cell Lung Cancer

Keywords

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Chemotherapy-naive Small Cell Lung Cancer SCLC Extensive disease ED topotecan Hycamtin oral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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topotecan/cisplatin

Intervention Type DRUG

etoposide/cisplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent (patient's written understanding of and agreement to participate in this study).
* Patients with confirmed extensive small cell lung cancer (SCLC).
* No prior chemotherapy within 5 years of the diagnosis of SCLC.
* Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
* At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
* At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria

* Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
* Any active infection.
* Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
* Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
* Use of an investigational drug within 30 days before the first dose of study medication.
* Women who are pregnant or lactating.
* Patients of child-bearing potential who refuse to practice an adequate form of birth control.
* Patients with clinical evidence of any stomach or intestinal (GI) condition.
* Patients requiring treatment with the drug cyclosporin A.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trial, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Hoover, Alabama, United States

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Chula Vista, California, United States

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Fountain Valley, California, United States

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Greenbrae, California, United States

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Poway, California, United States

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Rancho Mirage, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Soquel, California, United States

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Vista, California, United States

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Colorado Springs, Colorado, United States

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Norwich, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Miami Shores, Florida, United States

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Ocala, Florida, United States

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Pensacola, Florida, United States

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Tarpon Springs, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Cumming, Georgia, United States

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Decatur, Georgia, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Elk Grove Village, Illinois, United States

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Park Ridge, Illinois, United States

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Evansville, Indiana, United States

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South Bend, Indiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Frederick, Maryland, United States

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Pittsfield, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Reno, Nevada, United States

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Voorhees Township, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Valhalla, New York, United States

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Bismarck, North Dakota, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Lemoyne, Pennsylvania, United States

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Limerick, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Spartanburg, South Carolina, United States

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Memphis, Tennessee, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Abingdon, Virginia, United States

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Norfolk, Virginia, United States

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Olympia, Washington, United States

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Yakima, Washington, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Laramie, Wyoming, United States

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Vienna, Vienna, Austria

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Vienna, Vienna, Austria

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Vienna, Vienna, Austria

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Charleroi, , Belgium

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Edegem, , Belgium

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Haine-Saint-Paul, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Luxembourg, , Belgium

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Belo Horizonte, , Brazil

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Caxias do Sul, , Brazil

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Fortaleza, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Burgas, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Sydney, Nova Scotia, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Santiago, , Chile

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Beijing, , China

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Shanghai, , China

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Wangfujing, , China

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Xi'an, , China

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San José, , Costa Rica

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Tallinn, , Estonia

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Helsinki, , Finland

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Kangasala, , Finland

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Oulu, , Finland

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Caen, , France

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Calais, , France

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Strasbourg, , France

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Vesoul, , France

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Heidelberg, Baden-Wurttemberg, Germany

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Ebensfeld, Bavaria, Germany

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Gauting, Bavaria, Germany

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Großhansdorf, , Germany

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Tegucigalpa, , Honduras

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Budapest, , Hungary

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Hungary, , Hungary

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Genoa, Liguria, Italy

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Lazio, , Italy

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Roma, , Italy

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Roma, , Italy

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Kingston, , Jamaica

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Chihuahua City, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Apeldoorn, , Netherlands

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Arnhem, , Netherlands

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Ede, , Netherlands

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Harderwijk, , Netherlands

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Nieuwegein, , Netherlands

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Hamilton, , New Zealand

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Wellington South, , New Zealand

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Oslo, , Norway

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Panama City, , Panama

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Gdansk, , Poland

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Kielce, , Poland

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Ponce, , Puerto Rico

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Moscow, , Russia

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Moscow, , Russia

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Moscow Region, , Russia

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Singapore, , Singapore

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Nitra, , Slovakia

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Johannesburg, Gauteng, South Africa

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Seoul, , South Korea

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Seoul, , South Korea

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Valencia, Valencia, Spain

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Lleida, , Spain

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Taipei, , Taiwan

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Taipei, , Taiwan

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Aberdeen, Aberdeenshire, United Kingdom

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Nottingham, Nottinghamshire, United Kingdom

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Glasgow, , United Kingdom

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Leeds, , United Kingdom

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Leicester, , United Kingdom

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GSK Clinical Trials Call Center

Poole, , United Kingdom

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Countries

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United States Austria Belgium Brazil Bulgaria Canada Chile China Costa Rica Czechia Estonia Finland France Germany Honduras Hungary Italy Jamaica Lithuania Mexico Netherlands New Zealand Norway Panama Poland Puerto Rico Russia Singapore Slovakia South Africa South Korea Spain Taiwan United Kingdom

Other Identifiers

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104864-A/389

Identifier Type: -

Identifier Source: org_study_id