Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

PHASE3TerminatedINTERVENTIONAL
Enrollment

839

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Cisplatin

Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles

DRUG

Gemcitabine

Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

DRUG

PF-3512676

PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity

DRUG

Cisplatin

Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles

DRUG

Gemcitabine + Cisplatin

Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

Trial Locations (120)

100

Pfizer Investigational Site, Taipei

112

Pfizer Investigational Site, Taipei

704

Pfizer Investigational Site, Tainan City

1070

Pfizer Investigational Site, Brussels

1090

Pfizer Investigational Site, Jette

1200

Pfizer Investigational Site, Brussels

1529

Pfizer Investigational Site, Budapest

3000

Pfizer Investigational Site, Leuven

3500

Pfizer Investigational Site, Hasselt

4000

Pfizer Investigational Site, Liège

5703

Pfizer Investigational Site, Gyula

6000

Pfizer Investigational Site, Charleroi

6001

Pfizer Investigational Site, Port Elizabeth

Pfizer Investigational Site, Port Elizabeth

6772

Pfizer Investigational Site, Deszk

7405

Pfizer Investigational Site, Cape Town

7635

Pfizer Investigational Site, Pécs

10032

Pfizer Investigational Site, New York

12002

Pfizer Investigational Site, Castellon

17007

Pfizer Investigational Site, Girona

20100

Pfizer Investigational Site, Milan

23007

Pfizer Investigational Site, Jaén

33611

Pfizer Investigational Site, Bielefeld

34303

Pfizer Investigational Site, Istanbul / Ceraahpasa

35050

Pfizer Investigational Site, Bornova / Izmir

35233

Pfizer Investigational Site, Birmingham

35294

Pfizer Investigational Site, Birmingham

39008

Pfizer Investigational Site, Santander

44281

Pfizer Investigational Site, Kfar Saba

47100

Pfizer Investigational Site, Forlì

48903

Pfizer Investigational Site, Barakaldo

49085

Pfizer Investigational Site, Saint Joseph

55455

Pfizer Investigational Site, Minneapolis

56127

Pfizer Investigational Site, Pisa

63110

Pfizer Investigational Site, St Louis

63122

Pfizer Investigational Site, St Louis

68167

Pfizer Investigational Site, Mannheim

72076

Pfizer Investigational Site, Tübingen

74245

Pfizer Investigational Site, Löwenstein

76137

Pfizer Investigational Site, Karlsruhe

81675

Pfizer Investigational Site, München

82606

Pfizer Investigational Site, Bratislava

84101

Pfizer Investigational Site, Beersheba

93309

Pfizer Investigational Site, Bakersfield

99202

Pfizer Investigational Site, Spokane

99204

Pfizer Investigational Site, Spokane

100036

Pfizer Investigational Site, Beijing

101149

Pfizer Investigational Site, Beijing

110085

Pfizer Investigational Site, New Delhi

116023

Pfizer Investigational Site, Dalian

141001

Pfizer Investigational Site, Ludhiana

169610

Pfizer Investigational Site, Singapore

210002

Pfizer Investigational Site, Nanjing

226003

Pfizer Investigational Site, Lucknow

510060

Pfizer Investigational Site, Guangzhou

560027

Pfizer Investigational Site, Bangalore

A-6020

Pfizer Investigational Site, Innsbruck

20230-130

Pfizer Investigational Site, Rio de Janeiro

20231 -050

Pfizer Investigational Site, Rio de Janeiro

17210-080

Pfizer Investigational Site, Jaú

17210-120

Pfizer Investigational Site, Jaú

01219-000

Pfizer Investigational Site, São Paulo

01221-020

Pfizer Investigational Site, São Paulo

01224-010

Pfizer Investigational Site, São Paulo

M5G 2M9

Pfizer Investigational Site, Toronto

N8W 1L9

Pfizer Investigational Site, Windsor

N8W 2X3

Pfizer Investigational Site, Windsor

J4V 2H1

Pfizer Investigational Site, Greenfield Park

H7M 3L9

Pfizer Investigational Site, Laval

G6V 3Z1

Pfizer Investigational Site, Lévis

G1V 4G5

Pfizer Investigational Site, Québec

150 06

Pfizer Investigational Site, Prague

775 20

Pfizer Investigational Site, Olomouc

180 81

Pfizer Investigational Site, Prague

Unknown

Pfizer Investigational Site, Kowloon

Pfizer Investigational Site, Shatin

Pfizer Investigational Site, Taichung

H-8900

Pfizer Investigational Site, Zalaegerszeg

682 304

Pfizer Investigational Site, Kochi

411 004

Pfizer Investigational Site, Pune

00144

Pfizer Investigational Site, Roma

06132

Pfizer Investigational Site, S.Andrea Delle Fratte (PG)

1066 CX

Pfizer Investigational Site, Amsterdam

1502 DV

Pfizer Investigational Site, Zaandam

5211 RW

Pfizer Investigational Site, 's-Hertogenbosch

3844 DG

Pfizer Investigational Site, Harderwijk

6525 GA

Pfizer Investigational Site, Nijmegen

80-952

Pfizer Investigational Site, Gdansk

93-509

Pfizer Investigational Site, Lodz

05-400

Pfizer Investigational Site, Otwock

70-891

Pfizer Investigational Site, Szczecin-Zdunowo

00-909

Pfizer Investigational Site, Warsaw

01-138

Pfizer Investigational Site, Warsaw

02-781

Pfizer Investigational Site, Warsaw

44-300

Pfizer Investigational Site, Wodzislaw Sl.

3041-801

Pfizer Investigational Site, Coimbra

1099-023

Pfizer Investigational Site, Lisbon

1649-035

Pfizer Investigational Site, Lisbon

1769-001

Pfizer Investigational Site, Lisbon

4200-072

Pfizer Investigational Site, Porto

041 91

Pfizer Investigational Site, Košice

058 07

Pfizer Investigational Site, Kvetnica Pri Poprade

949 88

Pfizer Investigational Site, Nitra-Zobor

410-769

Pfizer Investigational Site, Gyeonggi-do

135-710

Pfizer Investigational Site, Seoul

137-701

Pfizer Investigational Site, Seoul

138-736

Pfizer Investigational Site, Seoul

03010

Pfizer Investigational Site, Alicante

08907

Pfizer Investigational Site, L'Hospitalet de Llobregat

06100

Pfizer Investigational Site, Ankara

BS2 8ED

Pfizer Investigational Site, Bristol

SO16 6YD

Pfizer Investigational Site, Southampton

SM2 5PT

Pfizer Investigational Site, Sutton

BT9 7AB

Pfizer Investigational Site, Belfast

DD1 9SY

Pfizer Investigational Site, Dundee

EH4 2XU

Pfizer Investigational Site, Edinburgh

G12 0YN

Pfizer Investigational Site, Glasgow

LE1 5WW

Pfizer Investigational Site, Leicester

NW3 2Qg

Pfizer Investigational Site, London

WV10 0QP

Pfizer Investigational Site, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00254904 - Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC | Biotech Hunter | Biotech Hunter