Know Cancer

or
forgot password

Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-Squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non Squamous Lung Cancer

Thank you

Trial Information

Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-Squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus


Inclusion Criteria:



- Proven diagnosis of locally advanced not suitable for local treatment, recurrent and
metastatic non-squamous cell carcinoma of the lung

- Positive for translocation or inversion events involving the ALK gene locus

- No prior systemic treatment for locally advanced or metastatic disease; Patients with
brain metastases only if treated and neurologically stable with no ongoing
requirement for corticosteroids

- Evidence of a personally signed and dated informed consent document and willingness
and ability to comply with scheduled visits, treatment plans, laboratory tests, and
other study procedures including completion of patient reported outcome [PRO]
measures.

- 18 years of age or older with the exception of India which has an upper age limit of
65 years old

Exclusion Criteria:

- Current treatment on another therapeutic clinical trial.

- Prior therapy directly targeting ALK.

- Any of the following within the 3 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, or cerebrovascular accident including transient
ischemic attack. - - Appropriate treatment with anticoagulants is permitted.

- Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation
of any grade, or QTc interval >470 msec.

- Pregnancy or breastfeeding.

- Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use
of drugs that are CYP3A4 substrates with narrow therapeutic indices.

- Known HIV infection

- Known interstitial lung disease or interstitial fibrosis

- Other severe acute or chronic medical conditions (including severe gastrointestinal
conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory
abnormalities that would impart, in the judgment of the investigator and/or sponsor,
excess risk associated with study participation or study drug administration, and
which would, therefore, make the patient inappropriate for entry into this study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Time Frame:

35 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A8081014

NCT ID:

NCT01154140

Start Date:

January 2011

Completion Date:

November 2013

Related Keywords:

  • Non Squamous Lung Cancer
  • open label
  • randomized Phase 3
  • first line treatment
  • non squamous lung cancer
  • ALK translocation event positive
  • Lung Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Washington Medical CenterSeattle, Washington  98195-6043
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Loma Linda University Medical CenterLoma Linda, California  92354
Ingalls Memorial HospitalHarvey, Illinois  60426
North Shore University HospitalManhasset, New York  11030
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Georgia Cancer SpecialistsDecatur, Georgia  30033
Seattle Cancer Care AllianceSeattle, Washington  98109
OHSU Knight Cancer InstitutePortland, Oregon  97239
Siteman Cancer CenterSaint Louis, Missouri  63110
Monroe Medical AssociatesChicago, Illinois  60603
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
SUNY Upstate Medical UniversitySyracuse, New York  13210
Tower Cancer Research FoundationBeverly Hills, California  90211
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
University of ChicagoChicago, Illinois  60637
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Oregon Health and Science UniversityPortland, Oregon  97201
Georgetown University HospitalWashington, District of Columbia  20007
Karmanos Cancer InstituteDetroit, Michigan  48201
Florida HospitalOrlando, Florida  32803
The Emory ClinicAtlanta, Georgia  30322
The Community HospitalMunster, Indiana  46321
Wishard Health ServicesIndianapolis, Indiana  46202-2859
Maine Center for Cancer MedicineScarborough, Maine  04074
Emory University HospitalAtlanta, Georgia  30322
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Hematology-Oncology Associates of Northern New JerseyMorristown, New Jersey  07962
Sarah Cannon Research InstituteNashville, Tennessee  37203
Methodist HospitalIndianapolis, Indiana  46202
Indiana University HospitalIndianapolis, Indiana  46202
Winship Cancer Institute - Emory UniversityAtlanta, Georgia  30322
Pharma ResourceEast Providence, Rhode Island  02915
Memorial Medical CenterLas Cruces, New Mexico  88011
Cancer Institute Of FloridaOrlando, Florida  32804
Beth Israel Deaconess Medical Center (BIDMC)Boston, Massachusetts  02215
CCTAPAnaheim, California  92807
Loma Linda University Medical Center PharmacyLoma Linda, California  92354
Loma Linda University Cancer Center-Schuman PavilionLoma Linda, California  92354
Records Management Only- Loma Linda Cancer CenterLoma Linda, California  92354
Kaiser Permanente Southern CaliforniaSan Diego, California  92108
CTTAPSan Diego, California  92120
Drug Shipment Address and Pharmacist Designees:Washington, District of Columbia  20007
Lynn Cancer Institute Center for Hematology OncologyBoca Raton, Florida  33486
Hematology and Oncology Consultants, PAOrlando, Florida  32804
Investigational Drug ServicesOrlando, Florida  32804
Emory University Hospital MidtownAtlanta, Georgia  30308
Ship Drug To: Al Fisher, Pharm D.Harvey, Illinois  60426
Monroe Medical AssociationMunster, Indiana  46321
Dana-Farber Cancer Institute (DFCI)Boston, Massachusetts  02215
Brigham and Women's Hospital (BWH)Boston, Massachusetts  02115
Karmanos Cancer Institute at Farmington HillsFarmington Hills, Michigan  48334
Siteman Cancer Center - West CountyCreve Coeur, Missouri  63141
UNM Eye ClinicAlbuquerque, New Mexico  87106
NSLIJ Health System/Monter Cancer CenterLake Success, New York  11042
Department of Medicine MSG at SUNY HSC at Syracuse, Inc.Oneida, New York  13421
Vincent ArmenioEast Providence, Rhode Island  02914
Henry-Joyce Cancer ClinicNashville, Tennessee  37232-5536
Vanderbilt Oncology PharmacyNashville, Tennessee  37232
University of Texas Southwestern University Hospital - St. PaulDallas, Texas  75232
University of Texas Southwestern University Hospital - Zale LipshyDallas, Texas  75235