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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 Medicine Saint Louis, Missouri  63110
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
University of Washington Medical Center Seattle, Washington  98195-6043
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Loma Linda University Medical Center Loma Linda, California  92354
Ingalls Memorial Hospital Harvey, Illinois  60426
North Shore University Hospital Manhasset, New York  11030
Ochsner Clinic Foundation New Orleans, Louisiana  70121
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
Long Island Jewish Medical Center New Hyde Park, New York  11040
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
University of Texas Southwestern Medical Center at Dallas Dallas, Texas  75235-8897
Georgia Cancer Specialists Decatur, Georgia  30033
Seattle Cancer Care Alliance Seattle, Washington  98109
OHSU Knight Cancer Institute Portland, Oregon  97239
Siteman Cancer Center Saint Louis, Missouri  63110
Monroe Medical Associates Chicago, Illinois  60603
Tower Hematology Oncology Medical Group Los Angeles, California  90048
SUNY Upstate Medical University Syracuse, New York  13210
Tower Cancer Research Foundation Beverly Hills, California  90211
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
University of Chicago Chicago, Illinois  60637
University of Texas MD Anderson Cancer Center Houston, Texas  77030
Oregon Health and Science University Portland, Oregon  97201
Georgetown University Hospital Washington, District of Columbia  20007
Karmanos Cancer Institute Detroit, Michigan  48201
Florida Hospital Orlando, Florida  32803
The Emory Clinic Atlanta, Georgia  30322
The Community Hospital Munster, Indiana  46321
Wishard Health Services Indianapolis, Indiana  46202-2859
Maine Center for Cancer Medicine Scarborough, Maine  04074
Emory University Hospital Atlanta, Georgia  30322
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Hematology-Oncology Associates of Northern New Jersey Morristown, New Jersey  07962
Sarah Cannon Research Institute Nashville, Tennessee  37203
Methodist Hospital Indianapolis, Indiana  46202
Indiana University Hospital Indianapolis, Indiana  46202
Winship Cancer Institute - Emory University Atlanta, Georgia  30322
Pharma Resource East Providence, Rhode Island  02915
Memorial Medical Center Las Cruces, New Mexico  88011
Cancer Institute Of Florida Orlando, Florida  32804
Beth Israel Deaconess Medical Center (BIDMC) Boston, Massachusetts  02215
CCTAP Anaheim, California  92807
Loma Linda University Medical Center Pharmacy Loma Linda, California  92354
Loma Linda University Cancer Center-Schuman Pavilion Loma Linda, California  92354
Records Management Only- Loma Linda Cancer Center Loma Linda, California  92354
Kaiser Permanente Southern California San Diego, California  92108
CTTAP San Diego, California  92120
Drug Shipment Address and Pharmacist Designees: Washington, District of Columbia  20007
Lynn Cancer Institute Center for Hematology Oncology Boca Raton, Florida  33486
Hematology and Oncology Consultants, PA Orlando, Florida  32804
Investigational Drug Services Orlando, Florida  32804
Emory University Hospital Midtown Atlanta, Georgia  30308
Ship Drug To: Al Fisher, Pharm D. Harvey, Illinois  60426
Monroe Medical Association Munster, Indiana  46321
Dana-Farber Cancer Institute (DFCI) Boston, Massachusetts  02215
Brigham and Women's Hospital (BWH) Boston, Massachusetts  02115
Karmanos Cancer Institute at Farmington Hills Farmington Hills, Michigan  48334
Siteman Cancer Center - West County Creve Coeur, Missouri  63141
UNM Eye Clinic Albuquerque, New Mexico  87106
NSLIJ Health System/Monter Cancer Center Lake Success, New York  11042
Department of Medicine MSG at SUNY HSC at Syracuse, Inc. Oneida, New York  13421
Vincent Armenio East Providence, Rhode Island  02914
Henry-Joyce Cancer Clinic Nashville, Tennessee  37232-5536
Vanderbilt Oncology Pharmacy Nashville, Tennessee  37232
University of Texas Southwestern University Hospital - St. Paul Dallas, Texas  75232
University of Texas Southwestern University Hospital - Zale Lipshy Dallas, Texas  75235