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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00254891
Other study ID # A8501001
Secondary ID
Status Terminated
Phase Phase 3
First received November 15, 2005
Last updated March 10, 2015
Start date November 2005
Est. completion date July 2008

Study information

Verified date March 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel


Description:

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.


Recruitment information / eligibility

Status Terminated
Enrollment 828
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV

- No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs

- Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

- Small cell or carcinoid lung cancer

- Known Central Nervous System (CNS) metastasis

- Pre-existing auto-immune or antibody mediated diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
PF-3512676 + Paclitaxel + Carboplatin
PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
Paclitaxel + Carboplatin
Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Locations

Country Name City State
Australia Pfizer Investigational Site Albury New South Wales
Australia Pfizer Investigational Site Bedford Park South Australia
Australia Pfizer Investigational Site Camperdown New South Wales
Australia Pfizer Investigational Site East Melbourne Victoria
Australia Pfizer Investigational Site East Ringwood Victoria
Australia Pfizer Investigational Site Nedlands Western Australia
Australia Pfizer Investigational Site Pimlico Queensland
Australia Pfizer Investigational Site Randwick New South Wales
Australia Pfizer Investigational Site Toorak Gardens South Australia
Australia Pfizer Investigational Site Townsville Queensland
Australia Pfizer Investigational Site Wodonga Victoria
Australia Pfizer Investigational Site Woolloongabba Queensland
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Liège
Canada Pfizer Investigational Site Moncton New Brunswick
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Rimouski Quebec
Canada Pfizer Investigational Site Saskatoon Saskatchewan
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Dalian, Xigang District Liaoning
China Pfizer Investigational Site Shanghai
Cyprus Pfizer Investigational Site Nicosia
Czech Republic Pfizer Investigational Site Nova Ves Pod Plesi
Czech Republic Pfizer Investigational Site Ostrava-Poruba
Czech Republic Pfizer Investigational Site Usti nad Labem
France Pfizer Investigational Site Angers cedex
France Pfizer Investigational Site Caen cedex
France Pfizer Investigational Site Dijon
France Pfizer Investigational Site Limoges
France Pfizer Investigational Site Nantes Cedex 2
France Pfizer Investigational Site Paris Cedex 13
France Pfizer Investigational Site St Herblain Cedex
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Toulouse cedex 9
France Pfizer Investigational Site Vandoeuvre Les Nancy
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Bielefeld
Germany Pfizer Investigational Site Bonn
Germany Pfizer Investigational Site Essen
Germany Pfizer Investigational Site Frankfurt
Germany Pfizer Investigational Site Karlsruhe
Germany Pfizer Investigational Site Muenchen
Greece Pfizer Investigational Site Athens Attica
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Heraklion Crete
Greece Pfizer Investigational Site Rio, Patras
Greece Pfizer Investigational Site Thessaloniki Macedonia
Hong Kong Pfizer Investigational Site Pokfulam
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Debrecen
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Chandigarh Punjab
India Pfizer Investigational Site Jaipur Rajasthan
India Pfizer Investigational Site Kochi Kerala
India Pfizer Investigational Site Pune Maharashtra
Israel Pfizer Investigational Site Zerifin
Italy Pfizer Investigational Site Lido di Camaiore (LU)
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Pavia
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Puebla
Netherlands Pfizer Investigational Site Amstelveen
Netherlands Pfizer Investigational Site Den Haag
Netherlands Pfizer Investigational Site Groningen GR
Netherlands Pfizer Investigational Site Tiel GLD
Poland Pfizer Investigational Site Otwock
Poland Pfizer Investigational Site Wodzislaw Sl.
Portugal Pfizer Investigational Site Faro
Portugal Pfizer Investigational Site Porto
Portugal Pfizer Investigational Site Porto
Portugal Pfizer Investigational Site Vila Nova de Gaia
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Cape Town
South Africa Pfizer Investigational Site Johannesburg
South Africa Pfizer Investigational Site Parktown Gauteng
Spain Pfizer Investigational Site Alcorcon Madrid
Spain Pfizer Investigational Site Badalona Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Pamplona Navarra
Spain Pfizer Investigational Site Santa Cruz de Tenerife
Spain Pfizer Investigational Site Valencia
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Uppsala
Switzerland Pfizer Investigational Site Lausanne
Taiwan Pfizer Investigational Site Taipei
United Kingdom Pfizer Investigational Site Exeter Devon
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Portsmouth
United Kingdom Pfizer Investigational Site Sheffield
United Kingdom Pfizer Investigational Site Surrey GU2 5XX
United Kingdom Pfizer Investigational Site Swansea
United Kingdom Pfizer Investigational Site Truro Cornwall
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Allegan Michigan
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Arlington Texas
United States Pfizer Investigational Site Asheville North Carolina
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Biddeford Maine
United States Pfizer Investigational Site Bountiful Utah
United States Pfizer Investigational Site Brevard North Carolina
United States Pfizer Investigational Site Brunswick Maine
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Burlington Vermont
United States Pfizer Investigational Site Canton Ohio
United States Pfizer Investigational Site Cedar Rapids Iowa
United States Pfizer Investigational Site Chattanooga Tennessee
United States Pfizer Investigational Site Chula Vista California
United States Pfizer Investigational Site Columbus Mississippi
United States Pfizer Investigational Site Corinth Mississippi
United States Pfizer Investigational Site Covington Louisiana
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Dover Ohio
United States Pfizer Investigational Site Dubuque Iowa
United States Pfizer Investigational Site Everett Washington
United States Pfizer Investigational Site Fayetteville Georgia
United States Pfizer Investigational Site Great Neck New York
United States Pfizer Investigational Site Gretna Louisiana
United States Pfizer Investigational Site Hot Springs Arkansas
United States Pfizer Investigational Site Jefferson Indiana
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Kennewick Washington
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Lafayette Louisiana
United States Pfizer Investigational Site Langhorne Pennsylvania
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Layton Utah
United States Pfizer Investigational Site Lexington North Carolina
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Little Rock Alaska
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Macon Georgia
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Marietta Georgia
United States Pfizer Investigational Site Marrero Louisiana
United States Pfizer Investigational Site Marrero Louisiana
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Murray Utah
United States Pfizer Investigational Site New Albany Indiana
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Oceanside California
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Palm Springs California
United States Pfizer Investigational Site Papillion Nebraska
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Provo Utah
United States Pfizer Investigational Site Richardson Texas
United States Pfizer Investigational Site Richland Washington
United States Pfizer Investigational Site Rockford Illinois
United States Pfizer Investigational Site Ruidoso New Mexico
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Scarborough Maine
United States Pfizer Investigational Site Shelbyville Kentucky
United States Pfizer Investigational Site St. Joseph Michigan
United States Pfizer Investigational Site Trophy Club Texas
United States Pfizer Investigational Site Tucker Georgia
United States Pfizer Investigational Site Tupelo Mississippi
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Worcester Massachusetts
United States Pfizer Investigational Site WVC Utah

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Cyprus,  Czech Republic,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival 656 Events No
Secondary Overall Objective Response End of Treatment No
Secondary Time to Tumor Progression Time of progressive disease No
Secondary Progression Free Survival Time of primary endpoint No
Secondary Duration of Response Time of progressive disease No
Secondary Patient Reported Outcomes End of Treatment No
Secondary Overall Safety Profile 28 days post PF-3512676 dosing Yes
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